The Newsletter of the Asia-Pacific Federation for Clinical Biochemistry
and Laboratory Medicine for circulation among APFCB and IFCC members only

APFCB News 2015
Publication Team, 2015 Issue
Chief Editor

Prof. Praveen Sharma
Jodhpur, India
praveensharma55@gmail.com

Immediate past
Chief Editor

Joseph B Lopez
Kualalumpur, Malaysia
jblopez2611@gmail.com

General andCase Studies Editors

Leslie Lai
Kuala lumpur, Malaysia
lesliecharleslai@gmail.com
Tester Ashavaid
Mumbai, India
dr_tashavaid@hindujahospital.com
Aysha Habib
Karachi, Pakistan
aysha.habib@aku.edu

APFCB Membership
Members
Australasian Association of Clinical Biochemists (AACB)
Chinese Society of Laboratory Medicine (CSLM)
Hong Kong Society of Clinical Chemistry (HKSCC)
Association of Clinical Biochemists of India (ACBI)
Indonesian Association for Clinical Chemistry (IACC)
Japan Society of Clinical Chemistry (JSCC)
Korean Society of Clinical Chemistry (KSCC)
Malaysian Association of Clinical Biochemistry (MACB)
Nepal Association for Medical Laboratory Sciences (NAMLS)
Pakistan Society of Chemical Pathologists (PSCP)
Philippine Association of Medical Technologists (PAMET)
Singapore Association of Clinical Biochemistry (SACB)
Association for Clinical Biochemistry, Sri Lanka (ACBSL)
Chinese Association for Clinical Biochemistry, Taiwan (CACB)
Thailand Association of Clinical Biochemists (TACB)
Vietnamese Association of Clinical Biochemistry (VACB)
Mongolian Association of Health Laboratorians (MAHL)
Corporate Members
Abbott Diagnostics
BD Diagnostics
Beckman Coulter
Bio-RadDiasorin Ltd
Diasys Diagnostic Systems, GmbH
Guangzhou Wondfo Biotech Co
Kopran Laboratories Ltd
Ortho-Clinical Diagnostics
PM Separations
Randox Laboratories
Roche Diagnostics
Sekisui Chemical Co
Shenzen Mindray Bio-Medical Electronics Co Ltd
Siemens
Sukraa Software Solution Pvt Ltd
SysmexTechnidata Medical Software
Affiliate Members
Chinese Association of Clinical Laboratory Management CACLM)
Association of Medical Biochemists of India (AMBI)
Macao Laboratory Medicine Association (MLMA)

APFCB News 2015
APFCB Executive Board and Chairmenof Committees, Elected October, 2015
Executive Board
President

Dr Leslie C Lai
Consultant Chemical Pathologist,
Kuala Lumpur, Malaysia
lesliecharleslai@gmail.com

Immediate Past
President

Mr Joseph B Lopez
MAHSA University College,
Kuala Lumpur, Malaysia
jblopez2611@gmail.com

Vice-President

Dr Sunil K Sethi
National University Hospital, Singapore
patsks@nus.edu.sg

Secretary

Dr Endang Hoyaranda
Prodia, Jakarta, Indonesia
ehoya@prodia.co.id

Treasurer

Dr Elizabeth Frank
BioChem Diagnostic Laboratory,
Mysore, India
anet21frank@gmail.com

Corporate Representative

Mr Alexender Wong
Siemens Healthcare Diagnostics Holding
GmbH, Germany
alexender.wong@seimens.com

Chairman of Committees
Communications

Prof. Praveen Sharma
All India institute of Medical Sciences Jodhpur,
India
praveensharma55@gmail.com

Education

Dr Samuel Vasikaran
Royal Perth Hospital
Perth, Australia
samuel.vasikaran@health.wa.gov.au

Laboratory
Management

Dr Tony Badrick
Brisbane, Australia
tony_badrick@snp.com.au

ScientificProf. Kiyoshi Ichihara
Yamaguchi University, Japanichihara@yamaguchi-u.ac.jp

Congress andConference

Mr Joseph B Lopez
MAHSA University College
Kuala Lumpur, Malaysia
jblopez2611@gmail.com

Hon. Auditors

Woei-horng Fang. Ph.D.
President Chinese Association for Clinical
Biochemistry, Taipei, Taiwan
whfang@ntu.edu.tw
Romeo Joseph Ignacio
Vice President & General Manager
Sysmex Philippines Inc.
Ignacio.RomeoJoseph@sysmex.com.ph

Submissions
The APFCB News welcomes suitable contributions for publication.
These should be sent electronically to the Chief Editor. Statements ofopinions are those of the contributors and are not to be construed as
Official statements, evaluations or endorsements by the APFCB or its
Official bodies.
Cover page: "Playing music on a Chinese zither while crossing abamboo-lined mountain stream by boat".
Contributed by Tan It Koon
Founding and Past President APFCB

Address

The registered address of APFCB is as follows:
APFCB, c/o Solid Track Management Pte Ltd.
150 Cecil Street, #10-06, Singapore 069543
Tel: 6223 9118 Fax: 6223 9131

APFCB News 2015

Contents
APFCB Activities
From the desk of Chief Editor - Praveen Sharma
Message from APFCB President - Leslie Charles Lai
APFCB Annual Report for 2015- Leslie Charles Lai
APFCB Work plan 2015 - Leslie Charles Lai
APFCB Auspices of Meetings

01
02
04
16
24

IFCC Activities
6th “ACBI-IFCC Task Force for Young Scientists”
Educational Symposium - Pradeep Kumar Dabla

26

Member Societies- Annual activities reports 2015
Association of Clinical Biochemists of India (ACBI)
Chinese Association for Clinical Biochemistry, Taiwan (CACB)
Indonesian association of clinical chemistry (IACC)
Japan Society of Clinical Chemistry (JSCC)
Korean Society of Clinical Chemistry ( KSCC)

31
38
42
48
50

Macao Laboratory Medicine Association (MLMA)
Mongolian Association of Health Laboratorians (MAHL)
Singapore Association of Clinical Biochemists (SACB)

52
53
54

FeaturesTan It koon- A Renaissance Man Shares His Life Experiences byJoseph Lopez

56

The Clinical Value of Assay Standardization and Traceability
Howard A. Morris

Therapeutic drug monitoring of rifampicin & isoniazid-

Chawla PK, Lokhande RV, Naik RV, Dherai AJ, Amale RA, Udwadia ZF, Mahasur AA, Soman R, Ashavaid TF.

Book Review
Clinical Cases In Laboratory Medicine -Jane French, Beverly Harris and William Marshall by Joseph

63

APFCB travel award - 53rd Annual Scientific AACB Conference

65

Corporate
Seimens- ADVIA Centaur Vitamin D Total 2015 ENDO/AACC/IFCC Posters

67

Lopez

APFCB Activities A

APFCB News 2015

From the desk of Chief Editor…
Dear Colleagues,
Greetings!
It is with a deep sense of satisfaction and fulfillment that I am before you with this annual
issue of APFCB News. It is my pleasure to come back to you with the new issue of
APFCB news 2015.
This issue is special in a way since it is the last annual issue of APFCB news; henceforth the
APFCB news shall be published biannually. It is due to the constant and unfailing efforts ofal the member societies and the corporate that the APFCB news has become a successful
and much awaited annual publication of APFCB.
I very much look forward to your sustained support in future to maintain APFCB website
as a very interactive and well updated representing the active picture of APFCB andreflecting its activities. So friends, please use this forum effectively to share your progress,
achievements and your thoughts and contributions on different issues related to theclinical biochemistry and laboratory medicine disciplines. My team shall be extremely
pleased to hear from you and this shall make the APFCB community well communicated.
This issue features a special article on Tan It Koon, the founding president of APFCB, who
has been a constant source of inspiration and has been actively involved in all the issues of
APFCB news till date by contributing his marvelous art work as cover page. Once again
the cover page of the current issue is an exemplary piece of art by Dr Koon, symbolizing
the blending of creative spirits and science.
Endeavoring further to fulfill of my commitments as chief editor, I shall steadfastly
continue my dedicated efforts to raise APFCB news to further heights.

Praveen Sharma
Editor in Chief

1

APFCB News 2015

APFCB Activities

Message from APFCB President…
Greetings to all members of the APFCB.
I would like to begin by thanking Prof Praveen Sharma for the excellent work he is doingas Editor-in-Chief of the APFCB eNews. There will be two issues a year from 2016.
We had to say good-bye to Mr. Martin Fuhrer, Corporate Representative to the APFCB
Executive Board as he resigned from Siemens on 31st August 2015. Mr Martin Fuhrer was
Corporate Representative to the Executive Board from October 2010 till the end of
August 2015. He was truly an asset to the APFCB and contributed significantly to theactivities and growth of the APFCB. On behalf of the APFCB EB I would like to thankMartin for the great job he did as Corporate Representative and wish him well for the
future. We will miss Martin.
The APFCB renewed its MoU with WASPaLM (World Association of the Societies of
Pathology and Laboratory Medicine) in August 2014 effective for a three year period from27th August 2014 and also signed an MoU with AACC on 11th December 2014 effective
for a two year period from 1st January 2015 till 31st December 2016. We have two
projects planned with WASPaLM, namely, a regional Chronic Kidney Disease project andone on Laboratory Accreditation. APFCB will be sponsoring a scientific symposium at the
WASPaLM World Congress to be held in Cancun from 18th till 21st November 2015.
Mr. Alexander Wong, also from Siemens, has been appointed as Corporate
Representative from 1st September 2015 till 31st December 2016 by the APFCB
Executive Board with the agreement of the corporate members to replace Mr. Martin
Fuhrer. Welcome Alexander!
The term of the current Executive Board ends on 31st December 2016. There will be a
new Executive Board from 1st January 2017 for a three year term. Elections will takeplace for the new Executive Board on 26th November 2016 just prior to thecommencement of the 14th APFCB Congress in Taipei this year.
I would like to invite all readers of the eNews to attend the 14th APFCB Congress in
Taipei from 26th till 29th November 2016. The theme of the congress is „Laboratory
Medicine in Cloud‟ and this promises to be a wonderful congress with a very strong
scientific programme and a good social programme. I would also like to thank in advancethe international, regional and national associations for supporting our congress bysponsoring symposia and plenary speakers, including the IFCC, WASPaLM, EFLM, AACC,
NACCCA and APFCB member societies. Thanks are also proferred to the Corporate
sector for their invaluable support of our congress.
From 1st January 2018 the IFCC Executive Board will have regional federation
representation. Each region will have to hold elections for its Regional Federation
Representative to the IFCC EB in 2017.

2

APFCB Activities

APFCB News 2015

The person elected must be able to present his/her region well. The APFCB Executive
Board will discuss this matter with the APFCB Council members at the Council meetingon 26 November 2016 so that elections will proceed smoothly in 2017.
The Malaysian Association of Clinical Biochemists (MACB) celebrated its Silver Jubilee inAugust 2015 and I was privileged enough to participate and deliver a plenary lecture on
tumour markers at the Silver Jubilee celebrations and annual scientific meeting of the
MACB. On behalf of the APFCB I would like to offer our congratulations to the MACB for
this important milestone.
Wishing all our readers a wonderful year ahead.

Dr Leslie Charles Lai
President, APFCB

3

APFCB News 2015 APFCB Activities
ASIA-PACIFIC FEDERATION FOR CLINICAL
BIOCHEMISTRY AND LABORATORY MEDICINE
Annual Report for 2015
1. APFCB Matters
Ordinary Members
The following National Societies are members of the APFCB:
1. Australasian Association of Clinical Biochemists (AACB)
2. Chinese Society of Laboratory Medicine (CSLM)
3. Hong Kong Society of Clinical Chemistry (HKSCC)
4. Association of Clinical Biochemists of India (ACBI)
5. Indonesian Association of Clinical Chemistry (IACC)
6. Japan Society of Clinical Chemistry (JSCC)
7. Korean Society of Clinical Chemistry (KSCC)
8. Malaysian Association of Clinical Biochemists (MACB)
9. Nepal Association for Medical Laboratory Sciences (NAMLS)
10. Pakistan Society of Chemical Pathologists (PSCP)
11. Philippine Association of Medical Technologists (PAMET)
12. Singapore Association of Clinical Biochemists (SACB)
13. Association for Clinical Biochemistry, Sri Lanka (ACBSL)
14. Chinese Association for Clinical Biochemistry, Taiwan (CACB)
15. Thailand Association of Clinical Biochemists (TACB)
16. Vietnamese Association of Clinical Biochemistry (VACB)
17. Mongolian Association of Health Laboratorians (MAHL)
Corporate Members
1. Abbott Diagnostics
2. BD Diagnostics
3. Beckman Coulter
4. Bio-Rad
5. Diasorin Ltd
6. Diasys Diagnostic Systems, GmbH
7. Guangzhou Wondfo Biotech Co
8. Kopran Laboratories Ltd
9. Ortho-Clinical Diagnostics
10. PM Separations
11. Randox Laboratories
12. Roche Diagnostics
13. Sekisui Chemical Co
14. Shenzen Mindray Bio-Medical Electronics Co Ltd
15. Siemens
16. SNIBE (Shenzhen New Industries Biomedical Engineering Co Ltd)
17. Sukraa Software Solution Pvt Ltd
18. Sysmex
19. Technidata Medical Software

Affiliate Members
1. Chinese Association of Clinical Laboratory Management (CACLM)
2. Association of Medical Biochemists of India (AMBI)
3. Macao Laboratory Medicine Association (MLMA)
4. Nepalese Association of Clinical Chemistry (NACC)

Office Bearers (1 January 2014 till 31 December 2016)

4

APFCB Activities APFCB News 2015
Executive Board
President
Immediate Past President
Vice-President
Secretary
Treasurer
Corporate Representative

Leslie Lai (Malaysia)
Joseph Lopez(Malaysia)
Sunil Sethi (Singapore)
Endang Hoyaranda (Indonesia)
Elizabeth Frank (India)
Martin Fuhrer (Siemens)

Chairs of Committees
Communications (C-Comm)
Congress and conferences(C-CC)
Education Laboratory
Management (C-LM)
Scientific (C-Sci)

Praveen Sharma (India)
Joseph Lopez (Malaysia)
Tony Badrick (Australia)
Kiyoshi Ichihara (Japan)

Executive Board meetings
The Executive Board held a meeting from 5th to 6th September 2015 in Singapore.

Resignation of Mr. Martin Fuhrer, Corporate Representative to the EB
The former Corporate Representative to the EB, Mr Martin Fuhrer, resigned from
Siemens on 31st August 2015. EB would like to records its thanks to Mr Martin Fuhrerfor his invaluable and tireless contributions to the APFCB which has helped greatly in theadvancement and growth of the APFCB and its activities. Mr. Martin Fuhrer elected by
the corporate members as Corporate Representative to the APFCB EB in October 2010
in Seoul, Korea re-elected for a second term in October 2013 in Bali, Indonesia.

New Corporate member to the APFCB EB
Agappe Diagnostics Ltd informed the APFCB in November 2014 that it no longer wished
to be a member of the APFCB. The APFCB EB welcomed the new Corporate
Representative, Mr. Alexander Wong of Siemens, when it held its EB meeting at theSiemens headquarters in Singapore on 5th and 6th September 2015. Mr. Alexander
Wong was elected to be the new Corporate Representative with the agreement of thecorporate members from 1st September 2015.

New Member
Ordinary member
MAHL was promoted from Affiliate membership to Ordinary membership in Mar 2015.

Affiliate member
NACC was accepted as an Affiliate member in October 2015.

Corporate members
Two new Corporate members joined the APFCB:
1. Guangzhou Wondfo Biotech Co in May 2015
2. SNIBE in October 2015

Memorandum of Understanding (MoU) between APFCB and AACC
An MoU between APFCB and AACC was signed on 11 December 2014 between the
President of APFCB and the CEO of AACC, Dr Janet Kreizman. The MOU is effective
for a period of two years from 1.1.2015 till 31.12.2016.

5

APFCB News 2015 APFCB Activities
Silver Jubilee Celebration

The MACB celebrated its Silver Jubilee at its Annual Scientific Conference from 3rd to
5th August 2015 at the Double Tree Hotel in Kuala Lumpur, Malaysia. The Presidentof APFCB presented the President of MACB, Dr Raja Elina Raja Aziddin with a crystal
memento from the APFCB.

From left to right: Dr Leslie Lai, President of APFCB, VIP Dato' Tan Yoke Hwa,
Director of Allied Health Sciences Division, Ministry of Health Malaysia, Dr Raja Elina
Raja Aziddin. President of MACB.

2. APFCB Activities
I. APFCB Education and Laboratory Management Committee (CELM)
Chair: Associate Prof Tony Badrick (Australia)

6

1.

IFCC-Abbott Visiting Lecturer for 2015 and 2016: Prof Howard Morris (Australia)
The topic of Prof Howard Morris‟s visiting lectureship was Vitamin D and bonedisease. Prof Howard Morris delivered his talks in Hong Kong, Australia, Seoul Korea
and Taipei.

2.

APFCB Travelling Lecturer for 2015and 2016: Associate Prof Graham Jones
Associate Prof Graham Jones spoke on the topic of Chronic Kidney Disease (CKD) in
the following countries Singapore, Vietnam, India (AMBI), China and Mexico (WAS Pa
LM World Congress). Associate Prof Graham Jones will deliver his lectures in Hong
Kong in January 2016 and will deliver a Plenary Lecture at the 14th APFCB Congressin Taipei in 2016.

3.

APFCB-AACB Travel Scholarships
The two winners of the 2015 APFCB-AACB Travel Scholarships to attend the AACBAnnual Scientific Meeting in Sydney were:APFCB Activities APFCB News 2015

Dr. Sudhesna Mohapatra of Neogen Labs Private Ltd, Bangalore, India who presented aposter entitled “Evaluation of newborn screening for the diagnosis of Carnitine Uptake
deficiency in Indian Population” and Jinia Lilianty of PT. Prodia Widyahusada, Jakarta,
Indonesia who presented a poster entitled “Vitamin A and Vitamin E deficiency
development in Indonesian Population”.
4. Planning of future Courses and Congress Symposia and Workshops
There will be two workshops for to be held at the 14thAPFCB Congress in Taipei in2016. The first workshop is a Joint WASPaLM-APFCB Accreditation Workshop with thefollowing topics covered by either APFCB or WASPaLM speakers;
1. Quality Systems Approach to Improvement
2. Introduction to ISO 15189
3. Ethical Practice/Governance
4. Staff training and competence
5. Request-Report cycle and error
6. QA/QC
The other workshop will be an APFCB Pre-analytical workshop with the following topics
and speakers:
1. Introduction and Chair – Joseph Lopez
2. Pre-analytical errors and quality improvement – Qing He Meng
3. Phlebotomy competence – solutions – Endang Hoyaranda
4. Haemolysis an ongoing problem – Tony Badrick
Also at the 14th APFCB Congress will be a hypothetical entitled “the value of pathology”
organized by the C-ELM in conjunction with Roche. The aim of this activity is to raiseawareness of the importance of Pathology testing.
Planning began in 2015 with Roche Diagnostics to develop a series of workshop/courses dealing with Lean-Six Sigma. These workshops will be jointly organized by the
local APFCB Ordinary Member or Affiliate Member Society, the APFCB and Roche
Diagnostics. The first of these will be run in Vietnam in 2016.
The Committee is also planning for a Chemical Pathology Course to be run in Malaysia
in 2016.The course will run for 3 days and will involve local and invited speakers. The
content will be developed from a curriculum based on the AACB Chemical Pathology
Course and is a pilot for this type of course in the region.
The APFCB will be sponsoring a symposium at the AACC 2016 Annual Meeting that has
already been accepted by the Organizing Committee. The programme and speakers are
as follows: Title of Symposium: Addressing pre and post analytical issues in developing
countries. Chair: Tony Badrick.
The APFCB will be sponsoring a symposium at the AACC 2016 Annual Meeting that has
already been accepted by the Organizing Committee. The programme and speakers are
as follows:
Title of Symposium: Addressing pre and post analytical issues in developing countries.
Chair: Tony Badrick.
1.
2.
3.

Driving change in the pre-analytical phase of testing Endang Hoyaranda
Understanding the impact of race and ethnicity on common tests Kiyoshi
Ichihara
Improving clinical commenting by a QA program Tony Badrick

5. Interpretative comments programme
There were six cases in 2015. The purpose of these cases and suggested responses isto provide some clinical cases for continuing education. Again there was a wide rangeof responses with between 15 and 45 participants for each case.

7

APFCB News 2015 APFCB Activities

6.

Young Scientist Competition (coordinated by Dra Endang Hoyaranda)
The APFCB Young Scientist Award Competition is a scientific paper competition
conducted by the APFCB through C-ELM with the following objectives:
1. To foster and encourage scientific inter-exchange amongst young scientists within
the Asia-Pacific region
2. To help and encourage young scientists in both written and oral communication of
their research results
Scientists under the age of 40 on 26 November 2016 (opening of the 14th APFCBCongress in Taiwan) are eligible for this competition. There will be 5 (five) young
scientists selected from all those who submit papers to present their papers as oralpresentations at the 14th APFCB Congress in Taipei, Taiwan, on 26-29 November
2016. A dedicated symposium during this congress will be allocated to thiscompetition. All five oral presenters will be sponsored by Siemens to attend the 14th
APFCB Congress and the Congress Organizing Committee has kindly agreed towaive registration fees. There will be a first prize winner of SGD 1,000 and a second
prize of SGD 500 sponsored by Siemens.

II. Scientific Committee (C-Sc)

Chair: Prof Kiyoshi Ichihara (Japan)

1.

Regional reference interval study (chaired by Prof Kiyoshi Ichihara)
After completing the study in Japan, China, Pakistan, India, and Philippines, teams in
Nepal, Malaysia and Bangladesh began to actively conduct the study for derivation ofcountry-specific reference intervals. Representatives for Nepal, Malaysia, India,
Pakistan are members of the C-Sci and all met and discussed the progress in Paris
during Euro Med Lab 2015 at the IFCC C-RIDL meeting.
A web-site was developed in June 2015 for evidence-based laboratory medicine(EBLM) based on results from the 2009 Asian multicenter study which provides
interactive viewing of information on sources of variations of reference values for 72
analytes: http://c-sci-apfcb.net/eblm/index.html.
Publications
Shimizu Y, Ichihara K. Sources of variation analysis and derivation of reference
intervals for ALP, LDH, and amylase isozymes using sera from the Asian multicenter
study on reference values. Clin Chim Acta 2015; 446: 64–72.
Masuda S, Ichihara K, Yamanishi H, Hirano Y, Tanaka Y, Kamisako T. The fluctuationof Clinical laboratory data across the menstrual cycle in healthy women with normal
cycles. Submitted to Ann Clin Biochem (to be accepted soon).
Jono H, Su Y, Obayashi K, Tanaka Y, et al. Sources of variation of transthyretin in
healthy subjects in East and Southeast Asia: Clinical and experimental evidence forthe effect of alcohol on transthyretin metabolism. Submitted to Ann Clin Biochem(under evaluation).

2.

8

New regional project on building a case record database of haematologicalmalignancy (chaired by Prof Kiyoshi Ichihara)
Making best use of value-assigned serum panel, a new project of building a welldefined, case record database of hematological malignancy in collaboration with four
Asian countries: Pakistan, Bangladesh, India, Japan is being planned. The purpose of the
project is to explore possible country specific differences in clinical and laboratory test
results of the disorders. The information will be useful for the practice of EBLM for
pathological conditions.

APFCB Activities APFCB News 2015
3.

Urine steroid metabolomic studies by gas chromatography mass spectrometry to aid
the diagnosis of disorders of sex development in Vietnamese children (working groupchaired by Dr Ronda Greaves)
The National Hospital of Pediatrics (NHP) has progressed well with this difficult
project. Dr Mai and her colleagues worked in the first half of 2015 to validate themethod. In May 2015, Dr Mai reported that her team was ready to commence
participation in the external quality assurance program offered by SKML in the
Netherlands and SKML advised that a mid-year enrolment was acceptable. From July
2015 NHP has been enrolled in the SKML programme for urine steroids and the 2015
material supplied has been used for initial evaluation of the method.
The 2016 SKML enrolment will be used as a formal EQA to confirm on-going method
performance. Once this has been established the reference interval and ratio studies
will be performed. All samples for these studies have been collected and are stored at-20oC awaiting analysis.

4.

Vietnam Chemical Pathology Course conducted under APFCB auspices (organized by
Dr Ronda Greaves)
The 7th Vietnam Chemical Pathology Course (CPC) was conducted on Saturday 6thJune 2015 in Ho Chi Minh City and on Tuesday 9th June 2015 in Hanoi. Speakers
were Assoc Prof Graham Jones, Dr. Dinh Thi Thanh Hoa (Clinical Biochemist, BachMai hospital, Ha Noi), Pharm. Tran Huu Tam (Director of CSQL of HCMC, Vietnam)
and Dr Ronda Greaves. The attendance was as anticipated with around 350
participants in Ho Chi Minh City and 200 participants in Hanoi. Post the CPC rerecordings were also made of the 6th Vietnam CPC; as the original recordings wereof poor quality. Discussions have commenced for the 8th Vietnam CPC for 2016.
Preliminary discussions are also in place to initiate a similar CPC in Yangon within thenext year.
All recordings will be made available online for the APFCB website in dual language
and also for the IFCC e-Academy in English.
Acknowledgements:
The APFCB thanks Roche Diagnostics Vietnam, particularly Mr Tien and Mr Rod
Ward, for their continued support of professional development in the region.

5.

Vietnam Workshops – Point of care testing (organised by Dr Ronda Greaves)
The 3rd Vietnam Point of Care Patient Testing Workshop was conducted in Ho Chi
Minh City on 11th June 2015 at the RMIT Vietnam Campus in District 3. Mrs Jo-Ann
Northfield (Royal Children‟s Hospital Melbourne POCT phlebotomy nurse / technician
and RMIT POCT Course workshop leader) and Dr Ronda Greaves conducted thisworkshop. On Friday 12th June 2015 a POCT half-day seminar was conducted inassociation with Jo-Ann Northfield, Mr Eric Law (Roche Diagnostics Singapore) and Dr
Ronda Greaves to present quality management solutions for POCT to senior hospital
officials. The eventuation of the potential Six Sigma Workshop did not progress in 2015
and is now planned for 2016. Discussions have commenced to expand the workshop
activities to Hanoi.
Acknowledgements:
The APFCB acknowledges the support of Roche Diagnostics Vietnam and Asia for theWorkshop and Seminar.

6.

Regional project for harmonisation of mass spectrometry-based steroid assays (working
group chaired by Dr Ronda Greaves)
The list of scientists / laboratories interested in participating in the APFCB Mass
Spectrometry (MS) Harmonisation working group continues to grow, withapproximately two thirds encompassing members of the AACB. This APFCB MS Mastergroup list has become quite large and required some time for management.

9

APFCB News 2015 APFCB Activities
After some initial discussions with the AACB CEO, Mr Peter Graham, the Master List
was transferred to the AACB Office for administration purposes.
The Office has agreed to send out emails on behalf of the APFCB Harmonisation
Working Group and will support maintaining the contact list. The first email trial,
which informed everyone on the list of this change (with an opt-out option) was
successful. This centralised list was also used to invite people to this year‟s open face
to face group meeting conducted on Wednesday 16th September 2015 during the
AACB Annual Scientific Meeting. The added advantage of this centralised approach isthat there is now a place to record the RSVP and attendance record for these annual
face to face meetings.
The work conducted by the group was initially focused on serum testosterone
analysis, with the plan to expand this work to other serum steroids in 2015. The
establishment of the DHT pilot programme within the RCPAQAP Endocrine program
was the primary focus of the 2015 harmonisation initiative.
For this project the working group obtained help from Prof Stefan Wudy (University
Giessen Germany) to establish targets for DHT and other steroid analytes using GCMS. These targets were successfully applied to DHT for the second cycle of 2015.
This is the first EQA scheme to offer DHT to our knowledge worldwide and theRCPAQAP have agreed to continue this into 2016.
One of the difficult hurdles to overcome is the establishment of commutability ofcommercial calibrators and the RCPAQAP material; as it is the base for the
harmonisation comparison. As an outcome of the 2015 AACB Annual Scientific
Meeting in Sydney, a Commutability Working Party was formed. This group‟s focus is
to establish the commutability of the RCPAQAP Endocrine material; including theserum steroids. The APFCB MS Harmonisation Working Group is represented on thisWorking Party. To date experimental studies are being developed.
Objectives still in early progress which will be carried forward into 2016:
Investigation of third party sources of quality control material and support
establishment of MS appropriate ranges for package inserts.
The
implementation of the BioRad MS ranges in the package inserts is still
outstanding.

Provision of longitudinal data for preterm infant steroids using traceablecommon calibrator. (Note: reference intervals have already been establishedand published for this group). The longitudinal neonatal hormone data analysis
is planned for later in 2016; based on a recent communication with statistician
Dr James Baglin.

Comparison of the common calibrator based MS testosterone method withpatient results obtained from immunoassay platforms. The New Zealand
Quality Assurance Group has requested support for harmonisation of theirimmunoassay serum testosterone methods against our groups LC-MS/MS
method. The samples have been collected and shipped to Australia and are still
awaiting analysis as the LC method is being revamped in order to add additional
steroids to the analytical run.

Travel to Hong Kong to promote harmonisation collaboration.

Publications
Lisa Jolly, Stefan A. Wudy, Michaela F. Hartmann, Chung Shun Ho, Richard KT Kam,John Joseph, Conchita Boyder, Ronda F Greaves. Establishment of an external quality
assurance program for serum dihydrotestosterone.

10APFCB Activities APFCB News 2015

Accepted as a hot topic oral presentation at the 53rd AACB Annual Scientific Meeting.
The abstract was published in the Clin Biochem Reviews 2015.
Ronda F Greaves, Janne Pitkin, Chung Shun Ho, James Baglin, Rodney W Hunt,
Margaret R Zacharin. Hormone modelling in preterm neonates: Establishment ofserum steroid reference intervals by LC-MS/MS. Accepted as an extended oralpresentation at the 53rd AACB Annual Scientific Meeting. The abstract was also
published in the Clin Biochem Reviews 2015.
A publication developing reference intervals using the “common” calibrator piloted by
the APFCB Harmonisation Working Group was published in JCEM in 2015; DOI:
http://dx.doi.org/10.1210/jc.2014-3681.This work developed mass spectrometry basedreference intervals for preterm neonatal serum for testosterone, 17OHP, androstenedione, cortisol and cortisone.
RF Greaves, L Jolly, MF Hartmann, SA Wudy. Should we target set our RCPAQAP
material when there are gaps in the traceability chain? Target assignment of 17-OHP,
androstenedione, DHEA and DHT by GC-MS/MS. Accepted as a poster presentation at
the 53rd AACB Annual Scientific Meeting. The abstract was published in the Clin
Biochem Reviews 2015.
Greaves RF, Ho CS, Hoad KE, Joseph J, McWhinney B, Gill JP, Koal T, Fouracre C, Iu Y,
Cooke B, Boyder C, Pham H, Jolly L. Achievements and future directions of the APFCB
harmonisation project on serum testosterone. Clin Biochem Rev 2015. Manuscript
submitted November 2015 and currently under review.
A systematic review of the literature has been conducted to ascertain the publishedreference intervals for MS based serum steroid assays.
This review, “Systematic review of serum steroid hormone reference intervals for mass
spectrometry methods”, has been registered with PROSPERO (CRD42015029637).
We are now in the process of collating the data for publication and distribution to the
APFCB MS working group in 2016 for further input.
7.

APFCB Chronic Kidney Disease (working group chaired by Associate Prof Graham Jones
who is also the APFCB Travelling Lecturer for 2015 and 2016)
The key activities have been coupled with the opportunities provided through the
APFCB Travelling Lecture Programme. Associate Prof Graham Jones delivered his
lectures in Singapore, Vietnam, India, China and Mexico in 2015.
Of the countries Associate Prof Graham Jones has visited there is a great need foraction in the area of CKD. In many laboratories, creatinine assays are not standardized,
although it seems likely that doctors are calculating the eGFR using smart phones orsimilar, based on the assumption of standardization. Similarly, while there appears to be
excellent co-operation between some laboratories and their local clinical renalcolleagues, there does not seem to be as much activity at the national organization level.
Associate Prof Graham Jones hopes that some of the presentations and discussions
obtained through the APFCB Travelling Lectureship may promote these activities.
A press release from KDIGO on 14th July 2015, KDIGOto Strengthen Implementation
Programs in Low and Middle Income Countries, may provide opportunities forcollaboration with clinical groups as the organization appears to have representatives
from a number of Asia-Pacific nations.

11APFCB News 2015 APFCB Activities
III. Communications Committee (C-Comm)
Chair: Prof Praveen Sharma (India)
1. APFCB website
The APFCB website (www.apfcb.org) was launched on 1st Nov 2011and is being
maintained with regularly updated comprehensive information on the organization
and activities of APFCB and its member societies. Access is made available throughthe site to the on-going scientific, educational and laboratory management
programmes of APFCB, to the activities of communication & publications committee
and to the photo gallery of these events. It also serves well as a source of information
for the APFCB Congress / regional meetings and future events. APFCB e-News andannual reports are conveniently published online on this platform making themreadily available to all the members. It also facilitates webinars on different aspects
related to clinical biochemistry and laboratory medicine.
The year 2015 witnessed the on-line live telecast of the Vietnam CPC in the month ofJune (6th June 2015) which was viewed by almost 200 people across the Asia-PacificRegion.
2. APFCB e-News:The APFCB e-News is published online on the APFCB web-site. This has ensured
wide reach of the e-News to all members at no additional cost.
As decided by the EB at its meeting in Singapore on 5th and 6th September 2015, the
APFCB e-News shall be published twice a year commencing in 2016. The C-Comm
has requested member societies through their National Representatives to contributeannual activities report for publication in the e-News.
3. Public Relations
A power point presentation on the APFCB, its members and its activities wasdeveloped by Mr Martin Fuhrer, Corporate Representative to the EB and is now
being updated regularly by the new Corporate member, Mr Alexander Wong since
Martin Fuhrer‟s resignation from Siemens. This power point presentation is ready for
use at member society conferences and at regional and international meetings topromote the APFCB.

IV. Congress and Conferences Committee (C-CC)
Chair: Joseph Lopez (Malaysia)
1. 14th APFCB Congress
The C-CC Chair has been in close contact with the Chair of the Organising
Committee of the 14th APFCB Congress on preparations for the congress. The latest
report from the OC is appended below.
The APFCB President and Chair C-CC visited Taipei on 24 Oct 2015 to confer with
the COC on preparations for the 14th Congress. A report of this visit has been
submitted to EB and the COC. One of the important points noted was thatsponsorship from the major vendors of diagnostic products was still not yet
forthcoming.
2.

12

APFCB auspices
The following conferences/courses have been granted APFCB auspices:APFCB Activities APFCB News 2015

i. EFLM-IFCC EuroMedLab, Paris, 21-25 June 2015
ii. Chemical Pathology Course 2015 that was held on 06 June 2015 in Ho Chi Minh Cityand on 09 June 2015 in Ha Noi, Vietnam, upon application received from Dr. Ronda
Greaves of the RMIT. The groups organising this meeting were the Vietnam
Association of Clinical Biochemists, Ho Chi Minh City Association of Clinical
Biochemists, Ho Chi Minh City Association of Medical Laboratory Technologists,
Roche Vietnam Co. Ltd. and RMIT, Melbourne.
iii. WASPaLM World Congress that was held in Cancun, Mexico from 18-21 November
2015.
iv. Cherry Blossom Symposium to be held in Seoul from 20-22 April 2016 in Seoul
College of Chemical Pathologists of Sri Lanka Annual Academic Sessions from 4-5
March 2016
3. The Chair of the C-CC has written an article entitled “APFCB Auspices of Meetings”
for the 2015 APFCB e-News as a way of informing learned societies in laboratory
medicine and APFCB members of the opportunity to apply for auspices
4. Turning Science into Caring (TSIC)
Abbott Laboratories has held TSIC meetings in the Asia-Pacific region over the past few
years in conjunction with the IFCC. The purpose of these meetings is to bringlaboratory and other healthcare professionals together to exchange information on
trends in laboratory medicine.
Following a discussion with a representative from Abbott at the EuroMedLab in Milan in
May 2013, the APFCB was invited to become a partner of these meetings. An
agreement to this effect was signed between the APFCB and Abbott on 22 July 2013
which enables the APFCB to be a partner and contribute to the planning of the scientificprogramme of TSIC meetings.
This year‟s TSIC meeting was initially planned for Bangkok, 2-3 September 2015.
However, due to the bombing that occurred in Bangkok the TSIC meeting was held in
Bali, Indonesia, 2-3 December 2015. The theme for this years‟ TSIC meeting was:Elevating the standard of patient care”. The APFCB was represented by Dr Elizabeth
Frank, Treasurer of APFCB.
5. Asia Pacific Federation for Clinical Biochemistry and Laboratory
Beckman Coulter (BC) Scientific Symposia

Medicine (APFCB)-

Ho Chi Minh City, Vietnam 8 October 2015
Jakarta, Indonesia 10 October 2015
Bangkok, Thailand 14 October 2015
The APFCB-BC Symposia was an educational series proposed by Beckman for the
purpose of raising the standard of laboratory medicine within the region. Beckman had
indicated that they were prepared to organise, fund and promote the series of symposia
in their selected cities – Ho Chi Minh, Jakarta and Bangkok..This report outlines theactivities for 3 events in these three cities within the APFCB region. Planning for theentire event began in May 2015.
Ms Ng Siew Bee from Beckman was the coordinator of the activities and had
discussions with Associate Prof Sunil Sethi who represented the APFCB and Beckman
Headquarters, particularly Dr Jack Zakowski, Director of Scientific Affairs andProfessional Relations at Beckman Coulter. Dr Zakowski also holds appointments
within the Board of Directors at Clinical Laboratory Standards Institute (CLSI) andCollege of American Pathologists (CAP). Dr Zakowski had agreed to participate in all
three of the APFCB –BC Symposia as a subject expert in the area of laboratory
standards, accreditation and the clinical value of specific biomarkers.
The series of APFCB-BC Symposia were held in hotels within the city centre and theprogramme was usually a one-day activity with a series of talks from local experts,
APFCB representative and BC expert.

13
13

APFCB News 2015 APFCB Activities
The events were generally well received and participation rates were between 70 150 participants, who were a mix of laboratory professional and technical staff as wellas medical staff. The audience was generally well engaged and there were lively Q&A
sessions and panel discussions as part of the planned activities. Overall, the scientificcontent was tailored in some ways to the needs and interests of the local laboratories
which helped maintain the interest. There was 16 also a small exhibition area whichfeatured BC equipment. This gave the event a rather nice conference with exhibition
atmosphere.
Each event was opened with formal introductions by the BC senior management
team, followed by Associate Prof Sunil Sethi representing the APFCB. The APFCB
hopes to continue to work with Beckman and perhaps enshrine the APFCB-BC
Symposia as a regular series rather than only for this occasion.

Report prepared by Leslie Lai with contributions from Joseph Lopez, Sunil Sethi,
Endang Hoyaranda, Kiyoshi Ichihara, Tony Badrick, Praveen Sharma, Ronda Greaves
and Graham Jones.

14

APFCB News 2015 APFCB Activities
APFCB WORK PLAN FOR 2015
1.

EB, Committee Chairs and Committee Membersi.

Promotion of the APFCB internationally, regionally and nationally, including atworkshops, conferences, scientific meetings and during visiting lectureships.
Recruiting new Full members, Affiliate members and Corporate members.
Maintaining good and strong relationships with other regional clinicalbiochemistry organisations, AACC, IFCC and WASPaLM.
An MoU was signed on 11 December 2014 between APFCB and AACC
effective for a period of two years beginning in 2015. AACC will besponsoring a symposium at the APFCB Congress in Taipei in November 2016
and the APFCB will be sponsoring a symposium at the 2016 AACC Annual
Meeting. APFCB and AACC will collaborate to provide education activities to
the Asia-Pacific region in the field of Clinical Chemistry and Laboratory
Medicine.

ii.
iii.
iv.

2.

Education and Laboratory Management Committee (CELM)
Chair: Associate Prof Tony Badricki.

IFCC Visiting Lecturer for 2015/2016: Prof Howard Morris (Australia)
The topic of Prof Howard Morris‟s visiting lectureship is Vitamin D and bone.

ii.

APFCB Travelling Lecturer for 2015 and 2016: Dr Graham Jones(Australia)
The topic of Associate Prof Graham Jones travelling lectureship is Chronic
Kidney Disease. Lectures will be delivered at the 14th APFCB Congress in
Taipei (Plenary Lecture) and in Hong Kong in 2016.

iii.

Planning for a Chemical Pathology Course in Malaysia in 2016
The course will run for 3 days and will involve local and some invited speakers.
The content will be developed from a curriculum based on the AACB Course.

iv.

Pre-Analytical Working Group to work together with EFLM
Pre- Analytical Group
There will be a pre-analytical workshop for the Taipei meeting in 2016. A
proposal was submitted for the 2016 AACC in 2015 and has been accepted by
the AACC 2016 Organising Committee. The APFCB-sponsored symposium at
the AACC 2016 Annual Meeting is as follows:
1. Driving change in the pre-analytical phase of testing Dra. Endang
Hoyaranda
2. Understanding the impact of race and ethnicity on common tests
Prof Kiyoshi Ichihara
3. Improving Clinical Commenting by a QA program Tony Badrick.

v.

Development of Material for self-directed learning for QA/QC/Lab
Accreditation on the webpage
The C-ELM webpage has seen some expansion with some material supplied
from Randox. It is expected that another two articles will be added in 2016.

vi.

Awareness of Environmental Impact of Clinical Laboratories
Mr Joseph Lopez and Dr Tony Badrick are also about to submit a second
article on this topic. A Survey of suppliers will be conducted to add further
information to this paper.

16

APFCB Activities APFCB News 2015vii.

14th APFCB Congress, Taipei, 26-29 November 2016
The C-ELM will be coordinating a session sponsored by Roche entitled the„Value of Pathology‟ event at the Taipei meeting in 2016. The format will be a„hypothetical‟.

3. Congresses and Conferences Committee (C-CC)
Chair: Mr Joseph Lopezi.

14th APFCB Congress, Taipei, 26 – 29 November 2016
The C-CC Chair has been in close contact with the Chair of the Organising
Committee of the 14th APFCB Congress on preparations for the congress.
The APFCB President and Chair C-CC visited Taipei on 24 Oct 2015 to confer
with the OC on preparations for the 14th Congress. A report of this visit has
been submitted to EB and the Congress OC. One of the important points
noted was that sponsorship from the major vendors of diagnostic products was
still not yet forthcoming.
The C-CC will continue to liaise with the OC and monitor preparations for the
congress.
A report has been prepared by Mr Joseph Lopez together with Prof WoeiHorng Fang, Chair of the 14th APFCB Congress OC (please refer to Appendix
1).

ii.

APFCB auspices
APFCB auspices will continue to be provided upon application after review by
the C-CC.

iii.

16th APFCB Congress.
The C-CC will issue an invitation to members in early 2016 to bid to host the
16th APFCB Congress at the APFCB Council meeting in Taipei.

iv.

Revision of the APFCB Congress Guidelines
The Chair of C-CC will draft a revised set of Guidelines for the APFCBCongress for presentation to Council before its meetings in November.

4. Communications Committee (C-Comm)
Chair: Prof Praveen Sharma
i.
ii.
iii.
iv.
v.
vi.
vii.
viii.

To publish the APFCB e-News 6 monthly from 2016
To maintain and further enhance the quality of the APFCB website.
To ensure that the information on the APFCB website is relevant and up to date.
Uploading learning materials developed by APFCB members and APFCB
Committees on the APFCB website.
To provide more active support for the web-based distance-learning activities
like webinars planned by C-ELM.
Multidisciplinary approach to patient care by obtaining educational material,
making it available on the web site and by providing links to other relevant
resources.
Develop a new PR brochure targeted to the general public, governments,
industry, etc.
Publicise and promote APFCB through participation at various National andInternational congresses and exhibit and promote „Clinical Biochemist Reviews‟.

17

APFCB News 2015 APFCB Activitiesix.
x.

To communicate with member societies requesting them to provide theirmember societies journals weblink on the APFCB website.
Establish a communication process among the committee members andmember society representatives to update and work on agreed upon activities
and initiatives.

5. Scientific Committee (C-Sci)
Chair: Prof Kiyoshi Ichiharai.

The regional multicentre study on reference values (RVs)a.

Expansion of the study
As of now, 5 countries in the APFCB region, Japan, China, India, the Philippines,
and Pakistan, have completed their studies for derivation of country specificreference intervals (RIs) and sources of variation analyses of RVs, which wereconducted as a part of the global multicentre project on RVs led by IFCC
Committee on Reference Intervals and Decision Limits.

b.

More analysis on sources of variation of RVs
Between-country comparison of RVs will be performed to elucidate geographicalregion and ethnicity-related differences in RVs. The most impressive findings
obtained so far are differential effects of BMI on test results depending on
ethnicity: i.e., higher sensitivity of HDL-C and ALT to BMI change in Japanese andChinese, compared with that in Indian, Pakistani, or Caucasian. The findings will
be confirmed by the additional results of RVs to be obtained from the three
countries.

c.

Publication of analytical results for the Asian and global RI studies
with international perspective
More papers will be published on analytical results of RVs obtained in the 2008−9
Asian study. The themes of the papers are (1) systematic analyses of sources ofvariation of RVs for 72 analytes measured, including sex- and age-related changes
profiles of major analytes, (2) detailed analysis of sources of variation of thyroid
function related tests, and (3) analyses of relationships among test results of ironrelated parameters, New papers on country specific reference intervals (RI) will
be published by the team scientists in China, India, and Pakistan. The C-Sci will
fully support their efforts.

ii.

Distribution of computer software for derivation of reference
interval (RI-Master)A beta version of the software was distributed at the pre-congress workshop
during 2013 APFCB congress. An updated version with improved user-interface
for intuitive use of the software is now available. The new version is not only forderiving the RI more flexibly by coping with various need for secondary exclusionand partition based on sources of variation of RVs. It is also capable of graphicaloutputs of analytical results including depiction of histogram and probability paper
plot of the RV distribution. The new version is to be distributed not only to themembers of the C-Sci but also to participants of the Taipei APFCB 2016 during
the hands-on statistical educational course.

18

APFCB Activities

iii.

APFCB News 2015

Development of a clinical case bank and a web-system for thepractice of EBLM
Accumulation of a clinical laboratory database, or a clinical case bank, targeting
major diagnostic categories, such as common haematological malignancy,
autoimmune diseases etc., are being planned in Japan by collaboration of four
national universities. The keen interest in joining the project was alreadyexpressed by C-Sci members of Bangladesh and Pakistan as well as IFCC C-RIDL
members of UK, Turkey and USA. The database is to be used as a source
reference data for the practice of evidence-based-laboratory medicine (EBLM).
The laboratory test results across the collaborating institutions are to beharmonised by use of serum panel produced for the global multicenter study on
RVs.

iv.

Hands-on course on statistics for laboratory medicine
As was done at the APFCB Congress 2013 in Bali, an intensive hands-on course on
statistics specifically required for conducting scientific research in the field ofclinical chemistry and laboratory medicine will be provided as a pre-congressworkshop at the 14th APFCB Congress in Taipei. Its objective is to enhance thescientific level of researchers in the APFCB region. The same course is also being
planned for the Nepal Association for Medical Laboratory Sciences (NAMLS) for
promotion of the scientific research in the country.

v.

Regional project for harmonisation of mass spectrometry-based
assays (chaired by Dr Ronda Greaves and deputy chaired by Dr CS
Ho)This regional activity originally focused on serum testosterone analysis by LCMS/MS. With the knowledge built from this activity, work has now expanded toinclude other steroids. In September 2015 we met face-to-face and via
teleconference at the AACB meeting held in Sydney to summarise our current
activities and plan for 2016. The resulting work plan for 2016 incorporates:a)Ongoing review of EQA performance for steroids analysed by MS andsupport establishment of MS based targets.
b) Expansion of the current initiative to focus on serum 17OHP analysis.
c) Investigate establishment of a pilot EQA program for serum DHEA.
d) Investigate commutability of the RCPAQAP Endocrine material in
conjunction with the AACB Commutability Working Party.
e) Complete systematic literature review and disseminate information for“serum steroid hormone reference intervals for mass spectrometry
methods”; PROSPERO registration CRD42015029637.

f) Comparison of the common calibrator based MS testosterone method withpatient results obtained from immunoassay platform.
Complete statistical analysis of longitudinal data for preterm infant steroids
using traceable common calibrator. (Note: reference intervals alreadyestablished and published for this group).
h) Continue investigation of third party sources of quality control material andsupport establishment of MS appropriate ranges for package inserts.
g)vi.

Development of regional appropriate methods and reference
intervals for complex biochemical tests for children. (coordinatedby Dr Ronda Greaves and Dr Tran Mai with supported by aqualified statistician Dr James Baglin)

19

APFCB News 2015

APFCB Activities

Disorders of sex development – urine steroids metabolomics project. This
project aims to develop a regional method for urine steroid profiles measured in
fresh and blotter urine samples. The project is conducted at the National
Hospital of Paediatrics (NHP) in Hanoi Viet Nam. From July 2015 NHP has beenenrolled in the SKML programme for urine steroids and the 2015 material
supplied has been used for initial evaluation of the method. The 2016 SKML
enrolment will be used as a formal EQA to confirm on-going method
performance. Once this has been established the reference interval and ratio
studies will be performed. All samples for these studies have been collected andare stored at -20oC awaiting analysis.

vii.

Training (co-ordinated by Dr Ronda Greaves in conjunction with
Roche Diagnostics).

Training activities proposed for 2016 to underpin quality scientific research andestablish further collaborations for APFCB are:a) 2016 Vietnam Chemical Pathology Course conducted in Ho Chi Minh City
(HCMC) and Hanoib) Workshop/s to be conducted in Vietnam including the 4th POCT
workshop.
c) 1st Myanmar Chemical Pathology Course.

viii.

Paediatric/ Endocrine Symposium at the EFLM-UEMS Conference
Warsaw 2016.
This proposed APFCB Symposium will incorporate the following presentations:a) Dr Tze Ping Loh - National Hospital Singapore – “Clinical Utility of Steroid
Analysis”b) Dr CS Ho - Prince of Wales Hospital Hong Kong – “Mass Spectrometry
Analysis of Serum Steroids”c) Prof Stefan Wudy – Giessen University Germany – “Interpreting Mass
Spectrometry data for the Diagnosis of Disorders of Sex Development ”d) Dr Ronda Greaves - RMIT / Murdoch Children's Research Institute
Australia; “Mass Spectrometry Reference Intervals for Serum Steroids”.

ix.

Addressing chronic kidney disease (CKD) in the Asia-PacificRegion (Chair of CKD working group: Associate Prof Graham
Jones)The overall goal is to support member societies (Ordinary and Affiliate members)
in developing policies for laboratory testing in CKD to match the clinical need intheir countries. The model is based on the IFCC-WASPALM Task Force on
Chronic Kidney Disease.
Proposed actions for the project:
a. A call for nominations from member societies to submit individuals to bemembers of this working group. This proposal of an individual should indicate
an interest in the area of a national policy on CKD testing. The individual
should have an interest in CKD.

20b.

Circulation of current recommendations from the TF-CKD for discussion andpossible adoption. In general, these are support for the KDIGO 2012
Guidelines for CKD diagnosis and monitoring, a recognition that collaboration
with the relevant national nephrology and other clinical organisations is vitaland that where possible a national approach is preferred.

c.

A meeting will be planned of nominees and other interested parties to be heldat the 14th APFCB congress in Taipei in November 2016.

APFCB Activities APFCB News2015d.

Nominees and national organisations will identify opportunities for improvements
in CKD-related testing and, if possible, the CKD Working Group will provide suchadvice and assistance as is possible

6. Corporate Representative Reporti.

A new APFCB Promotional Presentation Deck has been developed for the EB‟suse in raising awareness of the APFCB and its committee activities. The
presentation deck will be continuously updated, taking into account new
members as well as initiatives.

ii.

Formation of cross-committee Working Groups across the region on selecttopics for greater integration and impact across meetings, education, speakers,
and scientific publications, with Corporate member participation. Key topics
include laboratory quality and disease states of interest to the Asia- Pacific region.

iii.

Working with C-CC to understand the various mechanisms for Corporate
member participation and development of key metrics to track promotional andbranding activities, e.g., number of unique visitors per month, and outreach tomember associations. These numbers are useful indicators to justify marketing
spending by Corporate Members.

iv.

Convene a Corporate Members‟ meeting at the 14th APFCB Congress, Taipei,
26 – 29 November 2016, to foster deeper ties between EB and Corporate
Members.

Prepared by Leslie, with contributions from Tony badrick, Ronda Greaves,
Kiyoshi Ichihara Graham Jonesh Lopez, Praveen Sharma and Alexander Wong.
17 January 2016

21
21

APFCB News 2015

APFCB Activities

Progress report of APFCB Congress 2016
APFCB President Leslie Lai and Dr. Joseph Lopez, Chair, APFCB C-CC met theOrganising Committee on Saturday 24th October 2015 to discuss the progress of
preparations for the 14th APFCB Congress to be held from 26th-29th November 2016,
in Taipei. A power point presentation was made by Prof. Woei-horng Fang, Chair of theCongress Organising Committee (COC), Prof. Shu-Chu Shiesh, Chair, ScientificCommittee (SC) and other colleagues from the COC. Also present wererepresentatives from the professional conference organiser (PCO). The EB
representatives considered that overall preparations appeared to be on course. The
following are some key points of the progress:

221.

Scientific Programme:a. There are 4 plenary lectures and 24 symposia and the speakers and titles are inplace.
b. Dr. Kuo, Director-General of Centres for Disease Control Taiwan, has been
invited to be the Keynote speaker with the title of his talk being “Laboratory
Medicine in Cloud.”c. The abstracts submission system was opened in December 2015 and the closing
date is 31 May 2016.
d. APFCB Travelling Lecturer, Dr. Graham Jones is one of the plenary speakers.
e. Some APFCB national societies have not yet confirmed the themes of their talks
and speakers and we are actively tracking them and will reserve some rooms forlate additions of symposia.

2.

Taiwan Society of Laboratory Medicine (TSLM) accepted our invitation to include
their annual conference as a satellite meeting of the APFCB Congress. The timeframe of this satellite meeting will be on 26th - 27th November with the title “AsiaPacific Chinese Conference of Clinical Biochemistry and Laboratory Medicine” andMandarin will be used in this conference. This satellite meeting is expected to attract
more participants from China, Hong Kong, Macao, as well as the bulk of local
medical technologists. An effort is being made to attract the local clinical pathologists
to participate in the congress.

3.

Registration: USD 550 (same as Bali) for foreign participants; free registration for
scholarship holders. Daily registration will be USD 100 and an extra payment isrequired for the banquet. The registration system will be open in early 2016.

4.

Corporate Sponsorship:a. There are 2 diamond sponsors – Roche and Siemens.
b. However, some of the well-known vendors who are APFCB Corporate
Members have yet to register their interest in the congress. APFCB willassist the COC in contacting these prospective sponsors.
c. Local sponsors will be actively contacted in the coming months. Good local
vendor support is expected because of the participation of the TSLM.
d. There are still slots available for industrial workshops and it is expected thatthese will be taken up in the coming months by the major vendors.

5.

Venue: the venue of the congress will be the Taiwan International Convention
Centre (TICC). The entire building of the TICC is available for the period of the
APFCB Congress. The trade exhibition will be held at the Taiwan World Trade
Centre which is just across the road from the TICC. TICC, TWTC and the Grand
Hyatt are all within the vicinity of the iconic 101 Building and within walking distanceof each other and metro stations.

APFCB Activities APFCB News 2015

6.

Professional Conference Organiser (PCO):The local Enjoy-PCO will act as the congress‟s contact point. It will manage
everything, including registration, communication with speakers and participants,
accommodation arrangements, etc.

7.

Social:a. The reception for the opening will be held at the TICC.
b. Packed lunch will be provided to all registered participants on each day ofthe congressc. The congress banquet will be held at the Grand Hyatt hotel and will be
open to all registered participants for a fee. This venue can hold 800 guests.

8.

Promotions:a. The official web-site http://www.apfcbcongress2016.org/ will be
progressively updated.
b. It will be used for registrations and submission of abstracts.
c. A major promotional effort will be made at the IFCC General
Conference in Madrid.

9.

We are ready to provide venues for meetings of the APFCB EB and committees,
and the IFCC and its Divisions, Committees, if requested, and other joint meetings(e.g. APFCB-IFCC; APFCB-WASPaLM) that are held in conjunction with the
APFCB Congress.

Report prepared by Mr. Joseph Lopez with contributions from Prof Woei-Horng Fang

23

APFCB News 2015

APFCB Activities

APFCB Auspices of Meetings
Joseph Lopez

On behalf of the APFCB Congresses and Conferences Committee

One of the functions of the APFCB Congresses and Conferences Committee (C-CC) isthe conferment of the APFCB‟s auspices for scientific meetings within and outside theAsia-Pacific region. The provision of auspices simply means an endorsement by the
APFCB and it is mutually beneficial to both the event and the APFCB. In conferring its
auspices, the APFCB lends its prestige with the expectation that the meeting will be of astandard acceptable to it and there by attractgood participation. The APFCB in turnbenefits by raising its profile within the laboratory community.
Every application for APFCB auspices is treated on a case-by-case basis by the APFCB CCC. Scientific meetings, be they educational courses, seminars and conferences that areheld by learned societies of pathologyare favourably considered. Meetings by corporate
organisations that are not purely sales promotions but are educational and vendorneutral should consider making an application for auspices. Applications from meetings
with a purely commercial bias or which are organised for profit without the backing of
any learned society will be closely reviewed to see if they fit into the aims and ideals of
the APFCB; in such instances, auspices will only be awarded in exceptional
circumstances.
APFCB member societies, in particular, are encouraged to seek auspicesfor theirnational and other educational meetings. They may also seek IFCC auspices if the aremembers of that body. There is no fee for the provision of auspices from either
federation. Organisations wishing to apply for it should do so well before meeting
materials are prepared. The guidelines and application formsfor APFCB auspices areavailable on the APFCB website within the APFCB C-CC‟s web-page or may be obtainedby writing to the APFCB Secretary.
(JL is APFCB Immediate Past President, Chair of the APFCB C-C and a member of the
IFCC C-CC)

24

IFCC Activities

APFCB News 2015

IFCC - Task Force Young Scientists(TFYS) at ACBICON-2015, Chandigarh,
India, 25-28 November 2015
Association of Clinical Biochemists of India (ACBI) is supporting the IFCC-TFYS
educational sessions since 2010. In continuation Organising Committee of 42nd National
Conference of ACBICON-2015, PGIMER, Chandigarh, India supported the TFYS
sessions 2015, India. The sessions were designed especially for Young Scientists (YS)
included Preconference “Medical Writing CME” and first time conducted “ACBI-IFCC
TFYS Young Scientist Award 2015” fully supported by Organizing Committee. The
conference was held in Postgraduate Institute of Medical Education and Research(PGIMER). PGIMER, Chandigarh was conceived in 1960 as a center of excellence todevelop patterns of teaching in postgraduate medical education and attempt to produce
specialists in several disciplines of medicine with intensive research in the field of health.
Preconference “Medical Writing CME”
Wednesday, 25th November 2015
The CME was a part of continuous efforts of IFCC-TFYS for the education and trainingof young scientists. “Research” refers to a search for knowledge and “medical writing”
involves writing scientific documents of different types which include research-related
documents, related to disease or drug-related literature. It includes publication of articles
like manuscripts and abstracts for healthcare journals, websites, magazines or news
presented to suit the level of understanding of the target audience. This session was led
by an experienced academic trainers, with aims to provide structure and motivation
through writing a paper for publication.
The session was opened with welcome address by Dr Rajendra Prasad, Chair Organising
Committee and Dr Praveen Sharma, President ACBI followed by IFCC-TFYS
introduction by Dr Pradeep Kumar Dabla, Chair IFCC-TFYS. The first half of session was
Chaired by Prof Praveen Sharma & Dr Pradeep Kumar Dabla and second half by Dr
Venkatesh Thuppil, Advisor Quality Council of India and Dr MVR Reddy, Co-Editor IJCB,
EB-ACBI. Dr Praveen Sharma opened the first lecture of the programme titled“Understanding the Writing Process: Planning and Productivity” where he summarised
the writing process including its various steps & stages which were elaborated by next
speakers in row. He gave the idea of importance of planning to make the writing process
successful. Planning is most important part of formula called time management. Thus, headvised to keep yourself engaging achieving your goals and objectives.
The next lecture in row was titled “Breaking down the structure of papers to generate
writing goals: Manuscript Development” led by Dr Rajiv Erasmus, President Org
Committee IFCC-Worldlab Durban 2017. He gave a brief idea of manuscript
development and drafts each section of research paper in different headings andsubheadings. Getting started is often the most difficult part and for this reason it is best
to begin with the easiest sections. These are usually the methods and results, followed by
the discussion, conclusion, introduction, references and title, leaving the abstract until
last. Dr Pradeep Kumar Dabla delivered first talk of next half session titled “Techniques
for being an effective writer”.
He discussed important points to remember while preparing a well-structured andcomprehensive manuscript for a publication submission. Long gaps between writing
process interrupts the continuity of thought and ensure keeping all the necessary
information, e.g, all data, references and tables or figures at hand before start writing. He
emphasized on revision process to improve the quality of research manuscript.

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IFCC Activities

APFCB News 2015

Next speaker in row were Dr MVR Reddy for topic titled “Ethics involved in Publication
Process: Important to know”. Writing a scientific paper involves a high burden of
responsibility on the shoulder of its authors. Thus, he made an effort to elaborate various
ethical issues in practice of medicine and punishable by law. He presented the basic
principles and standards of Ethics in medical research and publishing so that honesty andintegrity can be maintained. Dr Shalmoli Bhattacharyya, Additional Prof, Biophysics,
PGIMER, Chandigarh delivered last lecture titled “Publishing your work: Importance of
Journal Selection & Submission”. Selecting the best target or good fit journal for yourresearch is a critical step.
It can save you considerable time and effort by avoiding rejection. It will help otherresearchers in your field to find your work and help in improving visibility. At the end ofsession, the house was made open for one to one interaction between speakers andparticipants where efforts were made to solve their queries. The session was closed withremarks by Dr Venkatesh Thuppil and vote of thanks by Dr Thungapathra M, Treasurer
ACBICON-2015. IFCC-TFYS is thankful to the Organising Committee, ACBICON-2015
for all their support provided in conducting a successful session while making an effort for
closing gaps in the understanding of “Medical Writing” process for students.

Persons in the first row (center), from left to right: Dr Shalmoli Bhattacharyya, Dr
Rajiv Erasmus, Dr Venkatesh Thuppil, Dr Praveen Sharma, Dr MVR Reddy, Dr
Pradeep Kumar Dabla, Dr Thungapathra M“ACBI-IFCC TFYS” Young Scientist Award- 2015 Thursday, 26th November 2015
The “ACBI-IFCC TFYS” Young Scientist Award- 2015, a unique session was introduced
first time by joint efforts of IFCC-TFYS & Organising Committee ACBICON-2015. The
5 young scientists from pan India covering all zones of ACBI were selected fromnumber of requests on the basis of their research work.
The selected young scientists presented their papers and were awarded with fullregistration, travel and 3 night accommodation supported by organising committee,
ACBICON-2015. The session was chaired by Dr. Alpana Saxena, Dir Prof,
Biochemistry, MAMC, Delhi & Dr. Pradeep Kumar Dabla, Chair, IFCC-TFYS. The
session was initiated with welcome note of Dr. Sadhna Sharma, Jt Org Secretary,
ACBICON-2015 followed by Dr. Alpana Saxena and then brief note on IFCC-TFYS by
Dr. Prdaeep Kumar Dabla. Selected 5 young scientists presented their research work in
row namely: Dr. Surupa Basu (from Kolkata), Dr. Prerna K. Chawla (from Mumbai),
Dr. Kritika Krishnamurthy (from Delhi), Dr. Anurag Sankhyan (from Delhi), Prabhat
Singh (from Puducherry) and interacted with audience for their queries. The session
was ended with award distribution to young scientists by Chairs session and closing
remarks by Dr. Sadhna Sharma.

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APFCB News 2015 IFCC Activities
These awards created a good example of advocacy and platform for young scientists tointeract and an opportunity of dedicated standalone session. TFYS is thankful to all our
senior members Prof. Praveen Sharma, President ACBI; Prof. Rajendra Prasad, Chair
Organising Committee, Prof. Graham Beastall, Past President IFCC for their immense
support and especially to our young colleague Dr. Arnab Pal, EB-ACBICON 2015 whoplayed an vital role in conducting TFYS sessions successfully.

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From Left to Right: Awardees with Chairs Session

Dr Kritika Krishnamurthy, Dr Prerna K Chawla, Dr Alpana Saxena (Dir Prof,
Biochemistry, MAMC, Delhi), Dr Pradeep Kumar Dabla (Chair IFCC-TFYS), Dr Surupa
Basu, Dr Prabhat Singh, Dr Anurag Sankhyan
The Young Scientists experience of participating in & attending“ACBI-IFCC TFYS” Young Scientist Award- 2015 is enumerated below:

Dr. Surupa Basu
Institute of Child Health, Kolkata, India
I would like to thank IFCC and ACBI for awarding me the coveted IFCC-TFYS Award at
ACBICON-2015 and for giving the opportunity to present my ongoing research on vitamin
D in primary idiopathic nephrotic syndrome. The title of my paper was “A Randomised
Controlled Trial to assess the effect of Vitamin D supplementation in Steroid Sensitive
Nephrotic Syndrome”. Our research group at Institute of Child Health, Kolkata is trying toestablish guidelines for vitamin D supplementation through research in children with thedisorder, who have high chances of bone disorders due to losses of vitamin D binding
protein in the relapse phase of their disease and prolonged treatment with corticosteroids.
Presenting my work and sharing research experiences with fellow biochemists was anenriching experience. I had the opportunity to discuss current trends and newer
technologies in laboratory practice with leaders and stalwarts of clinical biochemistry. The
platform was a gateway to make new acquaintances; it also enriched my knowledge baseand recharged me with great enthusiasm for higher learning. Thank You ACBI & IFCC!.

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IFCC Activities APFCB News 2015

Prerna K. Chawla
P. D. Hinduja Hospital & MRC,
Mahim, Mumbai, India
I would like to thank & appreciate the entire team of ACBICON 2015 who successfully
conducted a very well organized conference at PGIMER, Chandigarh. This conference has
been a real motivation tickling my brains to think newer ideas & approaches that can be
implemented in the field of research.
I am thankful to my guide Dr T.F. Ashavaid & the IFCC-TFYS members to allow me topresent my data in this incredible conference wherein I was awarded the ACBI-IFCC
TFYS Award on my topic entitled “GENETIC VARIANTS OF ABO BLOOD GROUP &CORONARY ARTERY DISEASE (CAD).” Our work focused on determining theassociation of the ABO blood group with CAD in Indians. The conference attendees haveappreciated the work done & have encouraged us to further work ahead in future
directions. I am happy to inform you, that the topic shall be further presented in aninternational conference. The entire ACBI-IFCC TFYS Award session was informative
nurturing newer ideas & good exchange of knowledge of ongoing research in India. I
convey my sincere thanks to you.

Dr. Kritika Krishnamurthy
Final Year, MD Biochemistry, PG Resident
Maulana Azad Medical College, Delhi, India
I, Dr Kritika Krishnamurthy, a final year MD Biochemistry student, was awarded the IFCCTFYS Young scientist award 2015 for my work on “NISCH and CDH1 promoter
hypermethylation in cfDNA of lung cancer patients and its correlation withclinicopathological variables” It was a really enriching experience for me to be selected &invited as a speaker to the ACBI-IFCC TFYS award session of ACBICON 2015,
Chandigarh. I was given the opportunity to present my work to an audience of such senior
and eminent researchers. Receiving such an award in recognition of my work so early in
my research career, has inspired me to work harder and help further cancer research. In
addition, I am grateful for the financial support towards my attendance to this prestigious
event. I want to thank ACBI & IFCC for this award. It has really motivated me to advance
my research towards better diagnostic and potentially therapeutic modalities for cancer.

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APFCB News 2015 IFCC Activities

Anurag Sankhyan
Innovation Awardee,
Center for Bio-Design, THSTI
Faridabad (Haryana), India
I am grateful to ACBI and IFCC for felicitating me with the prestigious ACBI-IFCC TFYS
award-2015 for my work titled “An array of human recombinant antibodies from naturally
recovered individuals for inhibition of preS1-hepatocyte interaction”. I appreciate ACBI-IFCC
for giving me the opportunity to present my work to an august gathering of Scientists andClinical Biochemists at ACBICON-2015, Chandigarh, India. The work entails generation ofneutralizing recombinant human mAbs from individuals naturally recovered from HBV
infection and using a combination of such human recombinant antibodies with defined
specificities to prevent/manage HBV infections, including those by possible escape mutants.
This work provides a new dimension for the development of better immunotherapeuticinterventions for hepatitis B. ACBI-IFCC TFYS Award has been an immensely enriching andmotivating experience. I congratulate the co-recipients of the award and acknowledge ACBI &IFCC for creating a wonderful platform for providing recognition to young fellows.

.
Dr. Prabhat
JIPMER, Pondicherry, India
I am writing to express my sincere gratitude to you and the committee for selecting me as arecipient of the ACBI-IFCC TFYS Award at ACBICON-2015, Chandigarh, India.
The title of my paper was “Luteinizing hormone-Follicle-stimulating hormone ratio as
Innovative biochemical predictor of post-partum depression.
I am so humbled to have been chosen for this award knowing that there were many qualified
applicants. Even though the event was a few months ago, the feelings are still present. This
experience is something that I will never forget, and I know that the effects of this will reachfar beyond the monetary sum of the award. I am doing post-graduation (M.D Biochemistry) at
JIPMER Pondicherry, India. My area of interest is meningitis and dengue. I like to come out
with innovative idea out of conventional knowledge of science.
Please accept my deepest thanks and appreciation for your philanthropy and for the privilegeof being inducted into the prestigious ACBI-IFCC TFYS Award at ACBICON-2015.

Report By: Dr Pradeep Kumar Dabla Chair IFCC-TFYS Email: pradeep_dabla@yahoo.com

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APFCB News 2015

Member Societies

2015
Association of Clinical Biochemists ofIndia Annual Report 2015
The year started with the newly elected office bearers elected at the General Body
meeting of the Association of Clinical Biochemists of India held in Jodhpur on December
12, 2014, taking up their office. The office bearers elected were:
PRESIDENT:

Dr. Praveen Sharma

VICE PRESIDENT:

Dr. Rajendra Prasad
Dr. S. V. Rana

ADVISOR:

Prof. K.P. Sinha

IMMEDIATE PAST PRESIDENT:

Dr. Jayashree Bhattacharya

GENERAL SECRETARY:

Dr. Rajiv Ranjan Sinha

IMMEDIATE PAST SECRETARY:

Dr. M.V. R. Reddy

TREASURER :Dr. Krishna Ranjan Prasad

JOINT SECRETARY:

Dr. Jairam Rawtan
Dr. Ram Binary Sinha

ZONAL COUNCIL MEMBERS
North Zone:

Dr. Seema Bhargava

South Zone:

Dr. T. Vijayakumar

East Zone:

Dr. Abhijit Pratap

West Zone:

Dr. T. F. Ashavaid

Central Zone:

Dr. Sanjeev Singh

Editor- in Chief, IJCB:

Dr. Praveen Sharma

National Representative to APFCB:

Dr. Rajiv R. Sinha, General Secretary, ACBI

Regional Meetings:
During this year many scientific activities were organized by State / Regional chapters of
ACBI in different parts of the country.
KERALA BRANCHThe Association of Clinical Biochemists of India – Kerala chapter along with Department ofBiochemistry, Pushpagiri Institute of Medical Science & Research Centre, Tiruvalla
conducted a one-day seminar on “Laboratory Accreditation and Quality Assurance” on 28th
February 2015. This program was co-sponsored by Kerala State Council for Science,
Technology & Environment (KSCSTE), Govt. of Kerala. Dr. Kannan Vaidyanathan, Prof &Head, Dept of Biochemistry & Organizing Secretary, welcomed over 270 delegates whocame from all over Kerala. Speakers covered different topics related to the process ofaccreditation of Laboratories under NABL & ISO 15189:2012. The 2nd program wasconducted by the Kerala Branch in association with the Believers Church Medical College
Hospital, Thirivalla was a 4 day “ISO 15189:2012 Internal Audit and Quality Management”
Training course from 30th April to 3rd May 2015. This training programme was attended by
35 delegates.

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Member Societies APFCB News 2015
UTTAR PRADESH STATE BRANCH
Uttar Pradesh ACBI representative Dr. Brijesh Rathore organized a one day meet on thevarious aspects of Quality Assurance at the Era‟s Lucknow Medical College & Hospital,
Lucknow on 16th March 2015. Speakers covered various topics related to the maintenanceof Quality Assurance in the laboratory.
MADHYA PRADESH BRANCHThe Madhya Pradesh ACBI Chapter organized a meet on 6th April 2015 in the Dept. Of
Biochemistry at Gajra Raja Medical College Gwalior. Dr. Arun Raizada, Head, Laboratory
Medicine, Medanta Hospital Gurgaon was the Key Speaker and he spoke on “Driving
transformative changes in clinical laboratory”. The meet was presided over by Prof. Dr.
Neelima Singh, Head, Dept. of Biochemistry, G R Medical College, Gwalior & Past
President, and ACBI.
BIHAR BRANCH
The Bihar brach of ACBI organized a 1 day CME on 28th June 2015 on the topic “GoodLaboratory Practices”. Past President, Dr Sucheta Dandekar of Seth G S Medical College,
Mumbai spoke on “Key Strategies towards improving Laboratory Quality”. This wasfollowed by a talk on “Defining Laboratory Quality & Understanding where the error
happens” by Dr Seema Bhargava, Sir Garage Ram Hospital, New Delhi. The last speaker
was Dr. Adarsh Pal Singh, Director Medical Affairs, Greater Asia, B D Diagnostics, whogave a talk on “Importance of Specimen Quality on overall Laboratory performance”.
SOUTH ZONE CONFERENCE
The Association of Clinical Biochemists of India Kerala chapter in association with, Researchand Development Department, MES Academy of Medical Sciences, Perinthalmanna and thesociety of Clinical Chemists of Kerala has organized a two day National conference on
Advances in Laboratory practices on 13th and 14th of June 2015 at the MES Medical
College Auditorium, Perinthalmanna. The conference was sponsored by Kerala State
council for science, technology and environment. Dr. T.Vijayakumar, Joint Secretary of
ACBI presided the inaugural function and Dr. V. Ramachandran, Deputy Dean, MES
Academy of Medical Sciences inaugurated the function. The proceeding of the conference
was released by Dr. George Abraham, Secretary, Society of Clinical Chemists Kerala
Chapter. Dr. DM Vasudevan, former president of ACBI delivered the key note address.
The Conference was attended by more than 100 faculty members and 150 researchers,scientists, laboratory personals and Post graduates from South India. The conference gave
in depth knowledge in lifestyle and metabolic diseases and advanced laboratory techniques
and biomarkers in their diagnosis. The invited speakers gave talks on the recent advanceson biomarkers in Kidney function (Dr. DM. Vasudevan), Ethics in Clinical Research andpractice (Dr. Rekha Raghavan), Lifestyle Diseases and Management (Dr. V. Jayapal),
Carcinoma associate fibrosis (Dr. Antony George), Genetics Testing- points to ponder by(Dr. Divya Pachat) Recent Advances in prenatal Diaganosis (Dr. Dinesh Roy). Around65
papers were received out of which 50 papers were selected for presentation at theconference and the papers were evaluated by a team of experts. The awards were
distributed in the valedictory function by Dr. Vasudevan, former President ACBI.
The GB elected the following as Executive Committee members for the year 2015. Dr.
Praveen Sharma as PRESIDENT, Dr. Rajendra Prasad, VICE PRESIDENT (I) & Organzing
secretary, ACBICON 2015, Dr . S. V. Rana - VICE PRESIDENT (II), ADVISOR-Prof. K.P.
Sinha, GENERAL SECRETARY- Dr. Rajiv Ranjan Sinha, TREASURER- Dr Krishna Ranjan
Prasad, JOINT SECRETARY: Dr. Jairam Rawtani (Jodhpur) & Dr. Ram Binay Sinha (Patna).
ZONAL COUNCIL MEMBERS-Dr. Seema Bhargava (North Zone), Dr T. Vijayakumar(South Zone), Dr. Abhijit Pratap (East Zone), Dr. T. F. Ashavaid (West Zone) & Dr Sanjeev
Singh (Central Zone).

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APFCB News 2015 Member Societies

DELHI STATE BRANCHThe Department of Biochemistry, Sir Ganga Ram Hospital (SGRH), under the aegis of North
Zone and Delhi Chapter of the Association of Clinical Biochemistry of India (ACBI),
conducted a CME titled “Current Health Perspectives” on Friday, the 20th of March, 2015.
With the belief that patient care is enhanced when clinicians and laboratorians functionsynergistically, the scientific session included academicians as well as practicing physicians of
Sir Ganga Ram hospital, New Delhi from the Department of Nephrology and Rheumatolgy &Clinical Immunology. The CME was coordinated & managed by Dr Seema Bhargava, Zonal
Representative (North Zone) & Dr Anjali Manocha (Delhi State Representative).
TAMIL NADU BRANCHThe Tamil Nadu branch of ACBI and the Department Of Clinical Biochemistry, Christian
Medical College, Vellore conducted a one day CME on 25TH July 2015 on the topic “Vitamin
D – its measurement techniques and Clinical Utility”. This CME was awarded 10 credit points
by the Tamil Nadu Medical University. Dr Victoria Job, Professor & Head of Clinical
Biochemistry & the organising secretary welcomed the delegates to the CME. Along withtalks on various measurement techniques for Vit D estimation, speakers from the departmentof Rheumatology, Endocrinology, Neonatology and Clinical Biochemistry spoke on the
Vitamin D‟s clinical role as an immuno modulatory molecule.
The TN Chapter‟s second CME in 2015 was conducted by The Clinical Biochemistry
Department, Cancer Institute, Chennai on 17th October 2015. Dr. R. Arivazhagan, TN
Representative and Head of the Department welcomed the gathering with brief introduction
about ACBI activities. Dr. A. Rathinavelu, the recipient of 2015 Fulbright Scholarship and the
Executive Director, R. Goodwin Institute for Cancer Research, Nova Southeastern
University, Florida, USA gave a presentation about “New Horizons and challenges in Cancer
Treatment”.
JAMMU & KASHMIR STATE BRANCH
A two day State conference “BIOCME- 2015 “ was organized by Department ofBiochemistry, Govt. Medical college, Srinagar, Kashmir under aegis of North Zone
Association of Clinical Biochemists of India (ACBI) & Indian society of Lead Awareness andResearch (INSLAR) on the Theme „Advances in Biochemical & Molecular Diagnostics: Recent
Research Trends‟ on 9th -10th May 2015. The J & K State representative & Head
Biochemistry, GMC, Srinagar, Dr Sabhiya Majid was the organizing Secretary of the meet.
President ACBI, Dr. Praveen Sharma, Head , Dept of Biochemistry, AIIMS, Jodhpur , Generalsecretary ACBI, Dr. Rajiv R. Sinha ,Professor & Head, Department of Biochemistry, Nalanda
Medical College ,Patna and Dr Seema Bhargava (Professor & Head, Department ofBiochemistry, SGRIMS, New Delhi & North Zone representative of ACBI along with Dr L.
M. Srivastava were invited speakers and actively participated in academic sessions.
2ndCME The 2nd Programme to be held under the aegis of North Zone ACBI was a 1 day
seminar on “Clinical Chemistry Update – 2015” organized by the Department ofBiochemistry, SKIMS, Srinagar, Kashmir under the organizing secretary Dr Syed Mudassar,
HOD, Biochemistry at SKIMS. The 2nd Programme to be held under the aegis of North Zone
ACBI was a 1 day seminar on “Clinical Chemistry Update – 2015” organized by the
Department of Biochemistry, SKIMS, Srinagar, Kashmir under the organizing secretary Dr
Syed Mudassar, HOD, Biochemistry at SKIMS

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Member Societies APFCB News 2015

The meeting brought together internationally reputed scientists and clinicians whose
continuing contributions towards clinical chemistry have advanced the field to a great extent.
The topics covered were diverse, from Quality Assurance, Lactose breathing tests, Ion
selective electrodes and Biomarkers of Liver fibrosis. This event was a unique opportunity toconnect with peers and learn about the latest trends in clinical research.
WEST ZONE MEET
The ACBI West Zone organized the 2nd of the One day lecture series in Clinical
Biochemistry on “Applications of Analytical Instruments in Clinical Diagnostics” on 4th July
2015 at P D Hinduja Hospital, Mumbai. The various techniques that were discussed were
Capillary Electrophoresis, FTIR, LC Mass Spectrometry, GC Mass Spectrometry, AAS &ICPMS etc. Each techniques was discussed in 2 parts i.e. The basic principles and thetechniques followed by clinical applications and case studies. Dr. T.F. Ashavaid was helped inher efforts by Dr. Sucheta Dandekar, Dr. Padma Chavan and Dr. Rohini Bhadre.
WEST BENGAL CHAPTER ACBIThe Department of Biochemistry, College of Medicine & JNM Hospital, Kalyani, West Bengalorganized "CliniTech: Workshop on Advances in Technology and Quality Assurance in ClinicalLaboratory" in association with ACBI on 3rd & 4th July, 2015. Prof. Praveen Sharma,
President of ACBI elaborated about the activities of the Association. The key note address
was given by Prof. T. Venkatesh, Past President ACBI. Dr. Subir Kumar Das, Prof & Head,
Biochemistry acknowledged contribution of all participants and sponsors.

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Member Societies APFCB News 2015

Award Presentation Ceremony
The General Body elected the following as Executive committee members for the year
2016. Dr. Rajendra Prasad as President. Dr. Poornima Manjrekar as Vice President (I) &Organizing Secretary ACBICON 2016. Dr. Dharamveer Yadav as Vice President (II), Prof. K.
P. Sinha as Advisor ACBI and Dr. Rajiv Ranjan Sinha as General Secretary. The Joint
secretaries elected were Dr. Thungapathra M & Dr. Ram Binay Sinha. Dr. Krishna Ranjan
Prasad was elected as Treasurer. The Zonal Council members elected were Dr. Seema
Bhargava (North Zone), Dr T. Vijayakumar (South Zone), Dr. Abhijit Pratap (East Zone),Dr. T. F. Ashavaid (West Zone) & Dr Sanjeev Singh (Central Zone).
This was followed by the valedictory function bringing the curtain down on 4 days of intense,
high level scientific sessions. The Organizing Secretary, Prof. Rajendra Prasad thanked all thedelegates and volunteers for making the conference a grand success. The Director,
PGIMER, Chandigarh, Prof. Y. K. Chawla congratulated Dr. Rajendra Prasad and his team forthe successful organization of the conference. After this Awards, Certificates and cash
prizes were distributed to all the award winners. The General Secretary, ACBI, Dr. Rajiv
Ranjan Sinha in his valedictory address heartily congratulated all the organizing committee
members and volunteers for their untiring efforts in making the ACBICON 2015, national
conference a great success.

ACBI FELLOWSHIP AWARD (FACBI)
Dr. Jasvinder K. Gambhir, Delhi ACBI- A. J. THAKUR DISTINGUISHED CLINICAL
BIOCHEMISTS AWARD Dr. Praveen Sharma, Professor & Head, Department ofBiochemistry, All India Institute of Medical Sciences, Jodhpur. ACBI ORATION AWARDS,
2015: AWADHESH SARAN MEMORIAL ORATION Dr Tester F. Ashavaid, Consultant
Biochemist & Head, Dept. of Lab. Medicine, P.D. Hinduja National Hospital & Medical
Research Centre, Mumbai.

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Member Societies APFCB News 2015
“Pharmacogenomics : implementation in medicine.” SETH G. S. MEDICALCOLLEGE &KEM HOSPITAL ORATION Dr. Harish C. Joshi, Department of Cell Biology & Winship
Cancer Institute, Emory University School of Medicine, Atlanta, USA. “Microtubules, Small
Plant derived molecules and uncontrolled cancer cell division.” DR T. N. PATTABIRAMAN
ORATION AWARD Dr. Shyam S. Chauhan, Professor, Department of Biochemistry, All India
Institute of Medical Sciences, New Delhi. “Transcription factor C/EBP-β mediates down

regulation of dipeptidyl-peptidase III expression by interleukin 6 in human glioblastoma cells.”
K. L. GUPTA MEMORIAL ORATION Dr. Kapil Mehta, Professor of Cancer Medicine(Biochemistry), The University of Texas MD Anderson Cancer Center Houston, Texas, USA“Circumventing cancer drug resistance in the era of personalized medicine” MRS. & DR G. P.
TALWAR ORATION AWARD Dr. B. C. Kabi, Director-Professor and Head, Department ofBiochemistry, Vardhaman Mahavir Medical College & Safdarjung Hospital, New Delhi “Vitamin D: rationalization vs sensationalization, “ DR. TARANATH SHETTY MEMORIAL
ORATION AWARD POPULAR LECTURE SERIES Dr. Anil Bhansali, Professor and Head,
Department of Endocrinology, PGIMER, Chandigarh. “ Emerging concept in pathophysiology

of T2DM “
OTHER AWARDS: K.P. SINHA - P.S. KRISHNAN AWARD FOR BEST PAPER PUBLISHEDIN IJCB 2015): Archana Verma, Vibha Singh, Praveen Jaiswal &R. D. Mittal " Genetic Variantsin miRNAs Associated with Renal Cell Carcinoma (RCC) Risk: A Pilot Study in North Indian
Population” Vol. 30, No 4 (Oct-Dec 2015), Year 2015. PITABUS – JAMUNA BURMAMEMORIAL AWARD Dr. Gangadhar Chaterjee, Dept. Of Biochemistry, Grant Med. College& JJ Hospital, Mumbai. "Capture and ligation probe-PCR (CLIP-PCR) for Molecular Screening
with application to active Malaria Surveillance for elimination". DR. P. S. MURTHY AWARD
DEVELOPMENT OF DRUG– Dr. Priyanka S Bhoj (MGIMS, Sewagram) Targeting folate
metabolism: A promising therapeutic rationale against Brugia maleyi infection. DR SITA DEVI
AWARD Dr. Chiranjit Ghosh, Deenanath S. N. Bose National Centre for Basic Sciences,
Kolkatta - Insulin sensitivity index (ISI 0, 120) potentially linked to carbon isotopes of breath
CO2 for pre-diabetes. NIMS BEST POSTER AWARD: CANCER: Dr. Dhairya H. Patel(Symbiosis School of Biomedical Sciences, Pune).
“To evaluate the Effects of a Polyphenolic Flavonoid Quercetin on the Metastatic
Characteristics of SK-MEL-28 Human Melanoma Cells” NON-CANCER : Ms. Ragini Khajuria(PGIMER, Chandigarh) Functional Characterisation of Mutations in Congenital Adrenal
Hyperplasia Patients (CYP21A2 Gene )” MGIMS (SEWAGRAM) AWARD: Dr. Chandresh
Sharma, Centre for Bio Design and Diagnostics, Translational Health Science and Technology
Institute, New Delhi “Generation of monoclonal antibodies specific to salmonella typhi as apotential candidate for improved typhoid diagnosis Dr. P. Usha Sharma Best Poster Award in
Genomic Proteonomic sciences – Clinical Application: Ms. Jyoti Kundu, PGIMER, Chandigarh“Differential Proteome Analysis of Peripheral Blood Mononuclear Cells from Patients ofConcurrent Active Tuberculosis and Type 2 Diabetes Mellitus”

36

PRESIDENT:

Dr. Praveen Sharma

Member Societies
Dr. Rajendra Prasad
APFCB News 2015

VICE PRESIDENT:

Dr. S. V. Rana
ADVISOR:

Prof. K.P. Sinha,

IMMEDIATE PAST PRESIDENT: Dr. Jayashree Bhattacharya
GENERALPRESIDENT:SECRETARY:

Dr. Rajiv Ranjan SinhaDr. Praveen Sharma

IMMEDIATE
PAST
SECRETARY: Dr. M. V. R. Reddy
VICE
PRESIDENT

Dr. Rajendra Prasad

TREASURER:

Dr. Krishna Ranjan Prasad
Dr. S. V. Rana

JOINT SECRETARY:

Dr. Jairam Rawtan

ADVISORDr. Ram Binay Sinha

Prof. K.P. Sinha

IMMEDIATE PAST PRESIDENT:

Dr. Jayashree Bhattacharya

GENERAL SECRETARY:

Dr. Rajiv Ranjan Sinha

IMMEDIATE PAST SECRETARY:

Dr. M.V. R. Reddy

TREASURER

Dr. Krishna Ranjan Prasad

JOINT SECRETARY:

Dr. Jairam Rawtan
Dr. Ram Binary Sinha

ZONAL COUNCIL MEMBERS
North Zone:

Dr. Seema Bhargava

South Zone:

Dr. T. Vijayakumar

East Zone:

Dr. Abhijit Pratap

West Zone:

Dr. T. F. Ashavaid

Central Zone:

Dr. Sanjeev SinghIMMEDIATE PAST PRESIDENT:

Dr. Praveen Sharma (Jodhpur, Rajasthan)37

APFCB News 2015

Member Societies

Chinese Association for Clinical Biochemistry(CACB)
This brief report summarizes some of the highlights of activities for CACB during the Yearof 2015. CACB held annual conference on March 21st and a new Board of Directors andBoard of Supervisors were elected by the General Assembly of CACB. In the regular Board
meeting held on June 1st, Dr. Woei-horng Fang was re-elected as the President of CACB
with the term from May 2015 to June 2017. Dr. Fang reaffirmed the commitment of CACB
to advocate the establishment and education of professional clinical chemistry medical
technologist.
The 12th CACB Board of Directors and Supervisors

During the 30th Joint Annual Conference of Biomedical Science (JACBS) held at the National
Defense Medical University Campus on March 21-22, 2015, we invited applied IFCCAbbott VLP for Dr. Howard Arthur Morris, Joint appointment Professor of Medical
Sciences, University of South Australia and Senior Medical Scientist, Chemical Pathology
Directorate, SA Pathology, to deliver a special lecture on “Vitamin D: Molecular actions
across a variety of biological systems”. He shared valuable experiences in bridging the basic
biomedical research and clinical application with his thorough studies of Vitamin D in
osteobiology and physiological homeostasis. CACB also organized a symposium “Current
Trend in Clinical Biochemistry” continuing the special lecture. Three speakers shared theexperiences and achievement in their research in advancing the field of clinical biochemistry.
Dr. Jing-Long.

38

38

Huang, MD, Professor of Pediatrics, Chang Gung University, Taiwan, also the Vice
Superintendent of Ghang Gung Memorial Hospital, Taiwan, presented “The Prediction ofAllergies in Taiwanese Children (PATCH) Study”. Sandy Huey-Jen Hsu, Medical
Technologist, Department of Laboratory Medicine, National Taiwan University Hospital,presented “Recent Advances in Biochemical Bone Markers,” echoing the topic of special
lecture from the clinical point of view. Professor Tsan-Zon Liu, Consultant Professor inTranslational Research Laboratory, Cancer Center, Taipei Medical University, presented“The potential impact of hydrogen as a preventive and therapeutic medical gas.

Member Societies APFCB News 2015
” Following the symposium, a student‟s research poster contest was also held. Overall, thetwo-day conference was very successful and truly an enjoyable academic gathering for theattending members of CACB.
CACB is actively communicating and collaborating with other scientific societies in Taiwan.
On 4 Nov 2015, with support of MSACL, CACB and Department of Laboratory Medicine ofChang-Gung Memorial Hospital jointly host a symposium of 'Application of Mass
Spectrometry in Clinical Diagnosis' at Linkou. The symposium was chaired by Dr. David
Herold, UCSD. The speakers and titles of the talk include: 'From prediabetes to diabetic
complications: what metabolomics can tell' by Dr. Ming-Shi Shiao, Chang-Gung U.;'Advancing Alzheimer disease diagnostics using mass spectrometry' by Dr. Mari L. DeMarco,
U. British Columbia; 'A mass spectrometry toolbox for measuring immunoglobulins' by Dr.
John R. Mills, Mayo Clinic; and ' Clinical quality control for multiplex assays' by Dr. Stephen
R. Master; Weill Cornell MC. The symposium was attended by more than 50 CACB
members and students.

Dr. Fang at welcome dinner with MSACL Board Chair Dr. David Herold and CACB
symposium speakers of 'Application of Mass Spectrometry in Clinical Diagnosis' at Linkou,
Taiwan (5 Nov 2015). MSACL will sponsor Mass Spec Symposia series containing six
symposia and one plenary lecture in APFCB Congress 2016.
Promotion and preparation of APFCB Congress 2016, Taipei, Taiwan 26-29 November
2016.

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APFCB News 2015

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Dr. Morris, Dr. Zhang, Dr. Koch, Dr. Fang, Dr. Wang, and Dr. Jones at the 12 th Chinese
Conference of Laboratory Medicine (Nanjing, 9-12 Sep 2015). Dr. Graham Jones (therightmost) is a plenary lecture speaker in APFCB Congress 2016. Dr. Yan Victoria Zhang is the
President of North American Chinese Clinical Chemists Association (NACCCA) and NACCCA
will sponsor a symposium in APFCB Congress 2016. Dr. Koch, is the President of American
Association for Clinical Chemistry (AACC) and AACC will sponsor a symposium in APFCBCongress 2016.

Dr. Fang with Dr. Pan, BaiShen, the President of Chinese Society of Laboratory Medicine(CLSM), EB members of CLSM and delegates from Taiwan, Hong Kong and Macao at the 12th
Chinese Conference of Laboratory Medicine (Nanjing, 9-12 Sep 2015). CSLM will sponsor a
symposium in APFCB Congress 2016.

APFCB President Dr. Lai and C-CC Chair Dr. Lopez visit Taipei (24 Oct 2015) for theinspection of APFCB Congress 2016 preparation.

Progress report of APFCB Congress 2016
APFCB President Leslie Lai and Dr. Joseph Lopez, Chair, APFCB C-CC met the Organizing
Committee on Saturday 24 Oct to discuss the progress of preparations for the 14th APFCBCongress to be held from 26th-29th November 2016, in Taipei. The meeting was presented
by Prof. Woei-horng Fang, Chair of the Congress Organizing Committee (COC), Prof. ShuChu Shiesh, Chair, Scientific Organizing Committee (SOC) and other colleagues from theCOC. Also present were representatives from the professional conference organizer (PCO).
The EB representatives considered overall preparations appear to be on course.

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Member Societies APFCB News 2015

The following are some key points of the progress:
1. Scientific Program:a. There are 4 plenary lectures and 24 Symposia have been arranged and the speakers andtitles are in place.
b. We invited Dr. Kuo, Director-General of Centres for Disease Control Taiwan, as Keynote
speaker with the talk Title: “Laboratory Medicine in Cloud.”c. The abstracts submission system was opened in December 2015 and closing date is 31
May 2016.
d. APFCB Travelling Lecturer Dr. Graham Jones is invited to be one of the plenary speakers.
e. Some APFCB national societies have not yet confirmed the themes of their talks andspeakers and we are actively tracking them and reserve some rooms for last addition of
symposium.
2. Taiwan Society of Laboratory Medicine (TSLM): accepted our invitation to include theirannual conference as a satellite meeting of the APFCB Congress. The time frame of thissatellite meeting will be on 26th-27th, November with a title of “Asia-Pacific Chinese
Conference of Clinical Biochemistry and Laboratory Medicine” and mandarin Chinese will
be used in this conference. This satellite meeting is expected to attract more participantsfrom China, Hong Kong, Macao, as well as a bulk of local medical technologists. An effort
is being made to attract the local clinical pathologists to participate in the congress.
3. Centre (TICC): The entire building of the TICC is available for the period of the APFCBCongress. The trade exhibition will be held at the Taiwan World Trade Centre which isjust across the road from the TICC. The TICC, TWTC and the Grand Hyatt are all within
the vicinity of the iconic 101 Building and within walking distance of each other and metro
stations.
4. Professional Conference Organizer (PCO):
a. The local Enjoy-PCO will act as the congress‟s contact point. It manage everythingsuch as registration, communication with speakers and participants,
accommodation arrangements, etc.
5. Social:a. The reception for the opening will be held at the TICC.
b. Packed lunch will be provided to all registered participants on each day of thecongressc. The congress banquet to held at the Grand Hyatt hotel will be open to all
registered participants. This venue can hold 800 guests.
6. Promotions:a. The official web-site http://www.apfcbcongress2016.org/ will be progressively
updated.
b. It will be used for registrations and submission of abstracts.
c. A major promotional effort will be made at the IFCC General Conference in Madrid.

THAILAND ASSOCIATION OF CLINICAL
BIOCHEMISTS (TACB) 2014

We are ready to provide venues for meetings of the APFCB EB and committees, and the IFCC
Each fiscal year is an exciting year for the Thailand Association of Clinical Biochemists
and its Divisions, Committees if requested and other joint meetings (e.g. APFCB-IFCC;(TACB). Many different
activities
take place
where
the majorityof the activities are
APFCB-WASPaLM)
that are heldin conjunction
with
the APFCBCongress.
centered around the voices and requests from the members of the association as well
as from various medical laboratories situated around the Kingdom of Thailand.

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Member Societies APFCB News 2015

Indonesian Association of Clinical Chemistry(IACC)
Laboratory Management & Quality Control Department
Preanalytical Seminar: Improving Preanalytical Quality in Patient with SpecificCondition
Quality is a very fundamental element in a laboratory management system. In order to improve
the quality and to ensure the accuracy of laboratory results, a comprehensive process oflaboratory testing must be monitored and evaluated continuously.
A laboratory should be able to identify the source of error, whether the source was in preanalytical, analytical, or post analytical phase, the errors could be corrected and prevented
accordingly.
General opinion assumed that the errors in a laboratory mostly happened in the analyticalphase, which is considered as the most complex phase in a laboratory process. Therefore
special approach has been focused on this phase, for example by the involvement in several
quality assurance programmes. In addition to this approach, an evolution in the technology oflaboratory instrumentation and automation also has resulted ingiven a significant improvementin accuracy, precision, and overall laboratory performance.
On the other hand, it is difficult to detect and correct error in the pre analytical phase. The
corrective action is focused by doing some preventive measures. In order to improve the qualityof pre analytical phase, Indonesian Association of Clinical Chemistry (IACC) has collaborated
with Becton Dickinson to perform a pre analytical survey program which is known as “May I
Help You Campaign” (MIHYC) since 2011. This The program has involved participants from 39
hospitals and laboratories from several areas in Indonesia and with more than 32 laboratories in
waiting list due the lack of surveyor number.
Realizing the importance of pre analytical phase, IACC proudly organized a pre analyticalseminar. In this event we discussed about several pre analytical issues which are often found indaily practice, such as specimen collection of neonates, pediatric, geriatric and cancer patients;
pre analytical phase for blood gas and electrolytes analysis and special handling of sample frompatients with diseases which causing abnormality to sample. We promoted MIHYC programand shared participants‟ testimonies in a mini presentation to give a better image of the benefitsof this programme to all participants. More than 180 participants coming from more than 12
cities in Indonesia attended this seminar discussing the importance of preanalytical phase inLaboratory Medicine. The responses from the audience were beyond our expectation. Basedon the feedback from the participants, they found the information very valuable and expected
IACC to conduct this kind of seminar in several cities in their provinces in order to raise up theawareness of Laboratory Medicine stakeholders in the marketplace.

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APFCB News 2015

Member Societies

Session I (Moderator: dr. July Kumalawati, SpPK(K))
Specimen collection and sample handling in special cases
Specimen collection in neonates and pediatricpatients(dr. Nuri Dyah I, SpPK)Specimen collection in neonates, pediatric, geriatric and cancer patients.

Specimen collection in geriatric and cancer
patient(dr. Lyana Setiawan, SpPK)

Session II (Moderator: dr. July Kumalawati, Sp PK(K))
Pre-analytical for electrolyte and blood gas test
Update of pre-analytical for electrolyte
and blood gas analysis(dr. Stefanus Lembar, SpPK)-

Anticoagulant for electrolyte and blood gas analysis
Specimen collection (arterial, vein, mix-vein)
Transportation of sample
The effect of sample type (plasma vs serum) on the result ofelectrolytes test, especially potassium

Session III
May I Help You Campaign Program: for better Preanalytical phase QC
MIHYC program and implementation- dr. Tjan Sian Hwa, M.Sc, SpPK
- dr. Samiha Salida Hamedan MARS-

Testimony from MIHYC participants- Dr. Ninik Sukartini SpPK the head of Laboratory
Medicine of Ciptomangunkusumo Hospital Jakarta- Hendra Apt Head of Pramita Laboratory
Jakarta

Introduction of program
The implementation of MIHYC, the advantages and the
problems

Sharing the benefit of MIHYC

Session IV (Moderator: dr. July Kumalawati, SpPK(K))
Handling of problematic samples due to patient‟s disease
Special handling of problematic samples due topreanalytical factors and patient‟s disease forhematology and coagulation test
(dr. Anggraini I. Winardi, SpPK)-Special handling of samples with problem due topreanalytical factors and patient‟s disease forchemistry and immunology analysis(dr. Anita Singh, MD, Pathology –India)-

Preanalytical factors that influence the quality of the sample
Patient condition/ disease that can influence the quality of the sample
How to handle problematic samples for hematology andcoagulation testing, such as sample with hemagglutination, plateletclumping, lipemic, icteric, hemolysis, and easily clotting citrate plasma,etc
Preanalytical factors that influence the quality of the sample
Patient condition/ disease that can influence the quality of the sample
How to handle problematic samples for chemistry and immunology
testing, such as serum which easily clots, serum which appear icteric,lipemic or haemolysis, etc

Dr. Tjan Sian Hwa SpPK., as Chairperson of Laboratory Management and Quality Controlof IACC presenting the MIHYC Programme

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APFCB News 2015

a. SCIENTIFIC SEMINAR: CHALLENGES FOR QUALITY IMPROVEMENT
Due to addressed the feedback from our participants during preanalytic seminar which held inJakarta, it was decided to have same topics in our scientific seminar in Makassar in 28-29 August
2015. As complementary, we have some topics for hemostasis and coagulation. Almost 400
participants were attended this event.
We opened the scientific seminar with the plenary lecture by dr. July Kumalawati SpPK (K).,
DMM., the president of IACC who presented her lecture topic “Increasing Quality Process andResult in Laboratory Medicine”. She highlighted the importance of communication between
internal and external laboratory people for better quality process and results in Laboratory
Medicine. This It was followed by the panel discussion oin hemostatis. Prof. Dr. Mansyur Arief
SpPK., Clinical Pathologist from Hasanuddin University Makassar was spoke about theimportance of preanalytic variables in hemostasis interpretation and followed by dr. Tutik
Harijanti SpPD., KHOM., Internist and Hematology - Oncology Medic Specialist from
Hasanuddin University Makassar who spoke on Diagnosis and Management of Deep Vein
Thrombosis and Pulmonary Embolism.

The president of IACC dr. July Kumalawati SpPK(K), DMM., lead the meeting discussion during
13th Working Congress of IACC

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President of IACC opened 13th Work Conference and Scientific Seminar accompanied by dr.
Darwati Muhadi SpPK the Chairman of Organizing Committee, Prof. Mansyur Arief, SpPK the
Head of Clinica Pathology Department of Hasanuddin University Makassar and dr. Agus. A.
Abdullah SpPK as the Head of Indonesian Association for Clinical Pathologist and Laboratory
Medicine (IACP) Chapter Makassar.

Participants of 13th Worki Conference and Scientific Seminar IACC
Right after panel discussion, two parallel workshops on Lean Management and Workflow Analysis
sponsored by Roche Diagnostic and Six Sigma-metric laboratory quality management sponsoredby Abbott Diagnostic were held.

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Member Societies APFCB News 2015

Participants cheerfully taken a picture together after Workshop on Lean Management and Work
flow Analysis.
On the second day, we had same topics for preanalytic seminar which held in Jakarta previously.
We also keep promote MIHYC programme for all participants which come from eastern part ofIndonesia.

Dr. Yenny Surjawan SpPK PhD., Dr. Noventy Febrina Msi, dr. Samiha S., MARS, Dr. Tjan Sian
Hwa SpPK and Dr. MI.Dyah SpPK during MIHYC Symposium during 13th Work Conference &Scientific Seminar IACC.
In order to support Young Scientist Community in Indonesia in this event, IACC delightfully
granted award for three participants for Oral Poster Presentation as follow:
1.
2.
3.

Dr. Sheilla Febriana, Hasanuddin University Makassar
Miftakh Nur Rahman, Prodia Laboratory Jakarta
Dr. Yesi, Andalas University Padang

During the 13th Work Conference and Scientific Seminar IACC, we had trade exhibition fromsome diagnostics companies and their distributors in Indonesia.

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APFCB News 2015

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Dr. Darwati Muhadi SpPK as the chairwoman of 13th Work Conference and Scientific Seminar
together with dr. July Kumalawati SpPK (K), DMM., opened the trade exhibition.
3. IACC co-hosted APFCB Beckman Coulter Scientific Symposium
The new collaborative initiative between APFCB and Beckman Coulter, the scientific symposium
held in Double Tree Hotel Jakarta in October 10th, 2015 and attended by around 100 IACC
members.

Dra. Endang Hoyaranda lead the panel discussion on Laboratory Management for Tomorrow with
Associate Professor Sunil Sethi (Singapore), Dr. July Kumalawati Sp PK(K), DMM (Indonesia) andJack Zawoski PhD FACB (USA).

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APFCB News 2015

Japan Society of Clinical Chemistry (JSCC)
The 55th Conference of the Japan Society of Clinical Chemistry
Yoshinori Iwatani, MD, PhD
Professor of Biomedical Informatics (Preventive Medicine),
Division of Health Sciences,
Osaka University Graduate School of Medicine
We held the 55th Annual Academic Conference of the Japan Society of Clinical Chemistry (JSCC)
in the Convention Center of Osaka University, Suita City, Osaka Prefecture from October 30 th toNovember 1st, 2015. We made “Opening the way to the future of Clinical Chemistry” the main
theme of the Conference.

The distinctive feature of the Conference was to promote young fellows to the chairs of researchpresentations in order to increase the admission of young researchers and to rejuvenate JSCC.
To select them, we asked the councilors of the Society to recommend the young fellows whowill be expected to become the central figures of JSCC. After all that, more than 630 people
participated in the Conference, and above all, young participants increased considerably.
Furthermore, the number of oral presentations by participants was 114 and reached a record
high. We prepared 2 special lectures, 4 educational lectures, 6 symposiums, 1 workshop, 7
project reports, 10 sponsored luncheon and evening seminars, and 1 presidential address. One of
special lectures was about the future of laboratory diagnostics and was presented by Prof.
Kiyoshi Ichihara, Yamaguchi University, and another was about omics sciences and was given by
Dr. Yoshihide Hayashizaki, Advisor to the President of RIKEN. Four educational lectures werepertaining to metabolomics (by Prof. Eiichiro Fukuzaki), microRNA (Prof. Yukio Kawahara), bigdata analysis (Dr. Jun Sese), and lipid metabolism (Prof. Shinji Kihara).
The symposium‟s six themes were the future of clinical chemistry, the safety evaluation of drugs,
preventive healthcare and bio bank, young researchers, mass spectrometry, and thedevelopment of human resources in genomic medicine.
A workshop of the Clinical Chemistry Academy was held on the analysis of routine laboratory test
abnormalities. Project reports were conducted by 7 expert committees for quality management,
nutrition, lipoprotein test, POCT, plasma protein, laboratory system, and test reagent.

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APFCB News 2015

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The contents of sponsored luncheon and evening seminars were about an index of blood sugar
control, early diagnostics of pancreatic cancer, zinc signaling, KL-6: diagnostic marker forinterstitial pneumonia, Helicobactor Pyroli infection and gastric cancer, the significance oflaboratory tests, reference interval, diagnostics of hepatoma, urine NGAL, and cardio-renal
syndromes. Lastly, I presented about preventive diagnostics, which is the genome andepigenome diagnostics for predicting and preventing the development of diseases, in presidential
address.
During the Conference, we were able to feel great potential of clinical chemistry and JSCC in
medicine and health sciences in the 21st century. Finally, we would like to express our sincere
appreciation to all of the members who offered cooperation in the planning and management of
the events, as well as to the sponsors for their understanding the concept of the Conference.

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Member Societies APFCB News 2015
Korean Society of Clinical Chemistry Annual Report 0f
2015 (KSCC)
National Meetings
Name of the Meeting

Date

Annual Meeting of
KSCC (I)

2015.
5.14.

Topic
Symposium 1; Comparisons and suggestions about procedure
manuals of clinical chemistry laboratory
Symposium 2; Research highlights
Symposium 3; Recent advances in hormonal testings
Symposium 4; Industry workshop (New tests in the field of clinicalchemistry)

Quality AssuranceWorkshop

2015.
10.
30.

Quality Assurance workshop for neonatal screening tests

Symposium 1; The basic requirements of accredited laboratory

Annual Meeting of
KSCC (II)

2015.
10.
30.

Symposium 2; Health insurance benefit standard – about clinicalchemistry tests
Symposium 3; Introductions for updated homepage of KSCC
Symposium 4; Industry workshop (New tests in the field of clinicalchemistry)

Symposium 5; CLSI guidelines applied to clinical chemistry
Education
 Procedure manuals of clinical chemistry laboratory
 Hormonal testings
 Neonatal screening tests
 The basic requirements of accredited laboratory Health insurance benefit standard – about clinical chemistry tests
 New tests in clinical chemistry CLSI guidelines applied to clinical chemistry
International Relations
 Attended „Euromed Lab Paris 2015‟ and promoted the „IFCC World Lab Seoul 2020‟
to the participants of the Congress Working APFCB committee members (2016)
 Pf. Yong Hwa Lee for the education and laboratory management
committee
 Pf. Hwan Sub Lim for the communications committee
 IFCC Network Laboratory for HbA1c in Korea (2012 - present)
 Pf. Junghan Song was working as a member of the „International Scientific Advisory
Board of IFCC World Lab Durban 2017‟
 Pf. Hyung-Doo Park was working as a member of the „IFCC C-STFT (Standardizationof FT4 and Harmonization of TSH Measurement)‟
 Dr. Eun-Hee Lee participated the „AACC ICHCLR Council meeting and HOG of 2015

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APFCB News 2015

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Additional Information
 IFCC Network Laboratory for HbA1c in Korea (2012-present)
Current Officer Bearer of KSCC (2015-2016) President: Pf. Gye Cheol Kwon (Chungnam National University College of Medicine) New Secretary General : Pf. Sang-Hoon Song (Seoul University College of Medicine) Treasurer: Pf. Hwan Sub Lim (Yonsei University College of Medicine) International Committee: Dr. Sung Eun Cho (Lab Genomics Clinical Laboratories)

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APFCB News 2015

Macao Laboratory Medicine Association (MLMA)
The AGM of Macao Laboratory Medicine Association was held on March 21st with scientificseminars. Four well-known speakers from Mainland China and Hong Kong were invited todeliver different seminar topics in clinical laboratory sciences. Their presentations cover wide
variety topics in molecular biology “molecular diagnostic in different age population andpersonalized medical care”, biochemistry “The usage of 2 serum protein markers for bonemetastasis－total P1NP and Beta CTx ”, “Effective Blood Center and hospital blood bankinventory system” of blood banking and “Ebola virus nucleic acid testing in Africa wildlife
condition” for virology. Over a hundred colleagues from laboratory medicine participated forseminars and discussions.

In May 21st to 24th, MLMA has travelled to Seoul, Korea for exchange visiting trip. We havevisited Korean Red Cross Blood Service for their general blood donation service, blood
preparation, supply division and the lab. Besides, the tour visit EONE reference laboratory for
their lab automation system. MLMA also visited Shinchon Severance Hospital and RDK office.

Community Activity Day was held on October 24th in order to promote residence attention on
personnel health issues and the importance of lab medicine. There were booths of point-ofcare for blood pressure, blood glucose monitoring. Moreover, blood donation service wasintroduced to encourage residence to donate blood. Parasite specimens were shown topromote personnel hygiene practice. Allergy testing and liquid base cytology for gynecology
were also presented to raise residence health awareness.

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APFCB News 2015

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Mongolian Association of Health Laboratorians (MAHL)
1.

The Mongolian Association of Health Laboratorians held its first convention on March 12 th, 2015
in Ulaanbaatar city. 166 lab doctors and lab technicians participated the convention during which
the following activities were carried-out: Presentation of past activities of MAHL, followed by Q&A.
 Presentation, discussion and approval of planned medium-term activities of MAHL.
 Election of the Governing board and President of the Association. (Prof. Ts. Enkhjargal was
re-elected as President of MAHL).

2.

MAHL organized the 1st Scientific Conference of lab technicians which took place on May 15,
2015. Sixty eight lab technicians participated the conference, and 14 papers were presented outof which three papers were selected for the Excellence award.

3.

The professional journal “Health laboratory” published by MAHL was accepted as a member ofthe Western Pacific Region Index Medicus (WPRIM).
The following trainings were organized by MAHL in 2015:
 One-day training on laboratory quality (May 22, 69 participants).
 One-day training for lab technicians on pre-analytical quality (September 09, 61
participants).
 One-day training for lab doctors and technologists on reference values (September 24, 37
participants).
 One-day training for lab doctors and technologists on clinical lab standardization (October
09, 170 participants).
 One-day training for lab technicians on best practices for laboratory procedures(November 27, 72 participants).
MAHL assisted the Joint health reference laboratory of the Ministry of Health, Mongolia, indeveloping its plan of actions for 2016-2020.

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4.

5.

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Singapore Association of Clinical Biochemists(SACB)
Singapore Association of Clinical Biochemists (SACB) started 2015 activities with their Annual
Scientific Meeting (ASM) on Saturday 28th March 2015 at Hotel Jen Tanglin, Singapore. It
coincided the mourning week of the late Mr. Lee Kuan Yew, Founding father of Singapore.
The one-day ASM was packed with 9 lectures supported by the diagnostic industry and wellattended by 143 participants and speakers. Associate Professor Sunil Sethi, President of
SACB, welcomed the attendees and led a one minute silence in memory of Mr Lee Kuan
Yew.
The first lecture was given by Dr Graham Jones, Sydpath St. Vincents Pathology, Australia,
speaking on “Chronic Kidney Disease - the Role of the Routine Laboratory” describing 5
stages of chronic kidney disease which range from Stage 1 normal with GFR 90
ml/min/1.73m2 to stage 5 kidney failure with GFR at <15mL/min/1.73m 2. Chronic kidneydisease being defined as either kidney damage or GFR <60mL/min/1.73m 2 for  3 months.
Low eGFR (calculated from MRD equation) and raised urine albumin values are markers fordeath, cardiovascular disease, end-stage kidney disease and acute kidney injury.
Dr Jones also spoke on “Getting the Right Answer to Manage the Patient - the Importance ofTraceability” that emphasized calibration hierarchy or the traceability chain of referencematerials, reference methods and reference laboratories. Laboratories should choose
methods which are traceable to good references (JCTLM listed), have low uncertainties forcalibrators, minimize changes over time, select and promote unbiased comparators (eg.
common decision points, reference intervals), and confirm performance with EQA andstandards.
(6-7)

Raising the Laboratory‟s Standard of Quality, was presented by Dr Raja Elina Raja Aziddin,
President Malaysian Association of Clinical Biochemists sharing her laboratory experience
with internal QC practices. Using a combination of Westgard multi-rules and Sigma metric,
63.6 % of all analytes achieved ≥ 3.0 sigma. This attainment was translated into an annual
cost saving of 58% from reducing waste and re-work. From the diagnostic market, Mrs.
Jolanda Pelloli, International Product Manager from Roche Diagnostics spoke on LDL-C
Direct Measurement – Don‟t Guess. Measure It! She shared the analytical performance of theassay and how LDL-C, Homocysteine, Lipoprotein (a) and hs CRP could form a risk
prediction model. The Dr Lincoln Tan, Urology Consultant, Singapore, introduced Emerging
Biomarkers in the Detection and Prognosis of Prostate Cancer by showing how the use of
sensitivity and specificity of PSA is not a strong predictor of prostate cancer. However therate of detection could be improved by using panels such as prostate health index ( phi) = [(-2) proPSA x √tPSA/fPSA ].
Lung Cancers Biomarkers by Dr Carlum Shiu, from Abbott Diagnostics Division, Singapore
was our next presenter. He shared that tumour markers play three key roles in lung cancer:
they can aid in the differential diagnosis between lung cancer and benign lung conditions; they
can help differential between small cell (SCLC) and non-small cell lung cancer (NSCLC); andthey can be used to determine efficiency of treatment or outcome. Useful tumour markers inlung cancer are CYFRA 21-1, CEA and SCC for NSCLC and ProGRP and NSE for SCLC.
Professor Dr Rosmawati Mohamed, Consultant Hepatologist from Malaysia shared herexperience on the clinical application of enhanced liver fibrosis test (ELF TM) in the assessmentof liver fibrosis discussing the clinical utility of the ELF test component assays, hyaluronic acid,procollagen III amino terminal peptide and tissue inhibitor of metalloproteinase 1.

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APFCB News 2015

Member Societies

Together they generate an algorithm with an ELF score of <7.7 = no fibrosis and an ELF
score>9.8 = fibrosis with recommendation of a liver work-up for further assessment offibrosis. ELF Score has received A1 recommendation from EASL 2015 guidelines on the
management of chronic hepatitis.
Mr. Kevin Davies from Ortho-Clinical Diagnostics, Singapore spoke on Total Lab Automation,
introducing concepts, streamline processes and enhance safety in laboratory practices.
Final lecture of the day was presented by Dr Irakli Jaliashvili Radiometer Medical, Denmark on
acute care testing – clinical relevance of parameters. In addition to measurement of arterial
blood gases, the Radiometer analyser is now able to measure whole blood bilirubin and foetal
haemoglobin in an acute care environment for intrauterine haemolysis.
The Annual General Meeting was held at the end of the scientific programme. Members had arewarding day with scientific updates and lots of catching up with friends. September saw thestart of our popular Education Programme conducted by SACB which is now into its
seventeenth year. Topics for this module included liver function tests, emerging global
pandemic threats-how can the laboratory respond faster, thyroid function tests, renal function
tests, reference intervals, ABO and Rh(D) testing and LIS and beyond. Early in October we
jointly hosted with Bio-Rad Laboratories (Singapore) Pte Ltd, Mr. Sten Westgard from Westgard
QC, USA on Setting new standards in the laboratory. This was a well attended dinner session
highlighting six sigma metrics across the testing spectrum: achieving world class quality from A(lbumin) to V(iral load).

President, Prof Sethi, presenting our speakers with a token of our appreciation.

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APFCB News 2015
A Renaissance Man Shares His Life Experiences
By Joseph Lopez, Immediate Past President, APFCB and past IFCC Executive Board Member
Most successful people achieve recognition in one field of endeavour. Fewer achieve it in two.
Rare, however, is the individual who has received success and recognition in three.
Such person is Dr. Tan It Koon, founder and past president of both the Singapore Association ofClinical Biochemists (SACB) and the APFCB. He was also an active council member of theSingapore Society of Pathology (SSP), Singapore National Institute of Chemistry and Federation of
Asian & Oceanian Biochemistry (FAOB).Besides his pioneering contribution to the advancementof the practice of clinical biochemistry in Singapore and the Asia-Pacific region, he is anaccomplished musician and a painter of international renown. He can truly be described as arenaissance man without any sense of hyperbole. Dr. Tan graduated with the BSc Honours (FirstClass) and PhD degrees from the University of Singapore (now known as the National Universityof Singapore, NUS).He was the first person in Singapore to receive formal training in Clinical
Biochemistry.
He obtained the Mastership in Clinical Biochemistry (MCB) professional qualification in a newly
introduced examination during his postdoctoral studies in the UK. Subsequently he also obtained
Fellowship of the Royal College of Pathologists (FRCPath, London) and became a Fellow of the
Academy of Clinical Biochemistry (FACB) in the USA. He then embarked on a long career at theSingapore General Hospital that spanned over 40 years. He has authored or co-authored morethan 140 scientific papers on many aspects of clinical biochemistry and sat on the editorial boardsof the profession‟s more renowned international journals. Dr Tanhas also taught in both the
Science and Medical Faculties of the NUS and served as an examiner for MSc, PhD and MD
candidates. During this time he was appointed to board and management positions in many local,
regional and international professional bodies, including the Singapore Professional Centre and theSingapore National Science Council. Dr. Tan was elected a Member of the IFCC Executive Board.
He was also appointed by the World Health Organization (WHO) as a Member of its Expert Panelon Health Laboratory, and a Member of its Committee on Biological Standardisation.
Dr. Tan was conferred two distinguished National Day Awards by the Government of Singapore,
one for excellence in public administration and provision of a highly proficient clinical laboratory
service, and another for his significant contributions to cultural and community development in
Singapore. He received the SACB-Boehringer Mannheim and SSP-Becton Dickinson awards for
significant contributions to the advancement of clinical biochemistry and pathology respectively.
For initiating the series of APFCB Congresses, the APFCB News, education and collaborative
research programs over more than 20 years, he received the inaugural Distinguished Service
Award from the APFCB. A special distinguished service award was conferred by Becton Dickinson
in recognition of his pioneering and continued efforts in raising the awareness of pre-analyticalproblems affecting the correctness and quality of patient testing results, through educational
lectures and publications for countries in the Asian-Pacific region. Dr Tan has been a practitioner
and advocate of the arts since his schools days.
He is an accomplished pianist, who has won several performance and composition competitions in
Singapore and Malaysia He championed the advancement of the arts in Singapore and has timeand again sat on or helmed many national bodies, such as the National Theatre Trust, Singapore
Cultural Foundation, Singapore Festival of Arts, Singapore Dance Theatre, Forum of Fine Art andthe South-East Asia Art Association.

59

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APFCB News 2015

In addition to all this, Dr. Tan is an accomplished Chinese brush painter of renown. His talent
has seen his works featured in major local and international exhibitions since 1971. His works
have appeared on the covers of the APFCB News and featured in Clinical Chemistry. In
February of this year Dr. Tan was invited by the alumni of the NUS to share his multidimensional life experiences in science, art and music with members of the alumni, the teaching
staff, postgraduates and undergraduates. The objective of the event was to stimulate interest in
the early development of interest, knowledge, skills or hobbies other that required for a specificprofession or desired work, in order to enjoy a more interesting and fulfilling life, particularly
after retirement from formal work. Undergraduates were encouraged to prepare forretirement even as they are just preparing to enter working life. Dr. Tan‟s presentation took
just over 2 hours. He gave a lecture of one and a half hours using Power-Point slides to illustrate
the oral presentation of his experience and show his works of art. This was followed by a piano
recital by him that featured the works of renowned music composers such as Bach, Elgar,
Schubert, Chopin, Grieg, Field, Joplin, among others. The recital was followed by a dinner. The
NUS Museum is currently holding an exhibition of his works of art from March to August thisyear. July 201557

Features APFCB News 2015
The Clinical Value of Assay Standardization andTraceability
Howard A. Morris
Howard A. Morris, School of Pharmacy and Medical Sciences, University of South Australia andChemical Pathology Directorate, SA Pathology, Adelaide South Australia 5000 Australia

Why is traceability of clinical laboratory measurements important for the community?
The interpretation of clinical laboratory reports is increasingly dependent on guidance frominternationally agreed clinical guidelines. An important example of this strategy is the diagnosisof hypercholesterolemia for estimating risk of coronary heart disease (CHD). Theinternational application of these clinical guidelines provides important lessons for the current
practice of laboratory medicine. CHD remains the leading cause of death worldwide with anestimated 17.5 million deaths in 2012 representing 31% of all global deaths. Evidence from
population studies and randomized, controlled clinical trials demonstrate that lowering blood
cholesterol reduces the risk of CHD (1). This knowledge prompted the establishment in1985 of the National Cholesterol Education Program (NCEP) to reduce the prevalence ofelevated blood cholesterol (1). Importantly the clinical data provided the foundation for thedefinition of critical target levels for blood cholesterol based on risk of CHD. A blood
cholesterol level less than 200 mg/dL (5.2 mmol/L) was considered Desirable, between 200
to 239 mg/dL (5.2 to 6.2 mmol/L) was considered Borderline and levels greater than 240
mg/dL (6.2 mmol/L) were considered High.
The definition of these limits was accompanied by a widespread public health campaign forpeople to know their blood cholesterol level and to take action to lower their cholesterol if
required. It immediately generated unprecedented attention on the performance andreliability of clinical laboratory testing indicating inadequate precision and accuracy of blood
cholesterol assays. The NCEP adopted performance goals for assay precision of less than 3%
and a bias within 3%. To meet these criteria it was necessary to develop a reference
measurement system for the assay of blood cholesterol such that its measurement in eachclinical laboratory was traceable to an international reference cholesterol standard. The
establishment of important clinical outcomes including disease severity or even death atspecific levels of an analyte is necessary for the use of biomarkers in clinical guidelines. The
implementation of clinical guidelines requires clinical assays traceable to internationalreference materials such that every laboratory can obtain the same result on the same
patient.

Development of a Reference Measurement System
The development of a reference measurement procedure for any analyte requires at least
three components: a primary reference material, a primary reference method and a networkof reference laboratories (2). For clinical measurements the analyte is most often in blood ora fraction of blood such as serum or plasma. This is a complex matrix and very often thismatrix interferes with the assay. This interference is known as a lack of commutability. The
commutability of all reference materials must be established by demonstrating that that thevalues of the reference material and human serum/ plasma specimens for an analytedemonstrate an identical relationship across at least two assay methods (3). An effective
method to overcome a commutability problem is to develop a secondary reference material
in which the analyte is present in the matrix used for clinical assays such as serum.
For cholesterol the USA national metrology institute, National Institute of Science andTechnology (NIST) has played a leading international role providing both primary andsecondary reference materials and developing and performing a secondary reference method
for cholesterol.
The primary reference material is purified cholesterol and secondary reference material isserum-based cholesterol while the primary reference method is isotope-dilution liquid
chromatography-tandem mass spectrometry assay for cholesterol. As well the US Centers
for Disease Control and Disease Prevention (CDC) in Atlanta, USA provide an alternative
secondary reference method for cholesterol, the Abell-Kendall method and coordinates the
network of reference laboratories (4).

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APFCB News 2015 Book Review
Clearly it is not practical for each clinical laboratory to adopt a reference measurement systemfor each of their assays. The current strategy is to interact with the manufacturers of reagentsand instruments to ensure that the calibrators provided to routine laboratories are traceable to arecognized international reference material. To assist the manufacturers to access recognised
reference materials, reference procedures and networks of reference laboratories, thelaboratory medicine profession through the International Federation of Clinical Chemistry andLaboratory Medicine (IFCC) and the metrology profession through the International Bureau of
Weights and Measures (BIPM) formed the Joint Committee on Traceability in Laboratory
Medicine (JCTLM). The JCTLM supervises three working groups, one to assess the suitability ofcandidate reference materials, a second to assess the suitability of candidate reference
procedures and a third to assess the performance of reference laboratory networks. The JCTLM
maintains databases for each of these activities providing an international source of information ofmaterials and services for manufacturers or laboratories.
Initially this strategy was very successful as the limited number of major manufacturers
collaborated strongly with the metrology institutes and professional bodies. However over thelast 20 years a very large number of new manufacturers have entered the market particularly in
China, India and South America. It is unclear whether they are adopting the principles of assay
traceability to the level required for high quality laboratory medicine practice. The principles ofmetrology, accepted in so many other aspects of our life such as any purchase by its weight, havenow been extended to laboratory medicine along with the resources for their international
application. Clearly not all analytes are currently covered by these developments and most are
chemical tests. Work is being undertaken to continuously expand the coverage and extend theapplication of metrology to hematology, microbiology and molecular pathology whereappropriate. However it is a responsibility of everyone working in laboratory medicine tounderstand the traceability of their assays and to demand from their suppliers‟ information suchas the international reference material to which their assays are traceable.
We also need to ensure that the reference material is appropriate for the clinical care of ourpatients. Consultation with the clinicians using their service regarding the clinical use of their
testing and its application to international clinical guidelines is very useful here.

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Features

APFCB News 2015

Therapeutic Drug Monitoring of Rifampicin &Isoniazid
P.K. Chawla1, R.V. Lokhande2, P.R. Naik2, A.J. Dherai1,2 , R.A. Amale3, Z.F. Udwadia3, A.A. Mahasur3,
R. Soman4, T.F. Ashavaid1,21Research Laboratories, 2Dept. of Laboratory Medicine, 3Dept. of monary
Medicine,
4
Dept. of Internal Medicine, P. D. Hinduja Hospital & MRC, Mumbai - 400 016, India. Corresponding
Author: Dr T. F. Ashavaid. Email: dr_tashavaid@hindujahospital.com; tashavaid@gmail.com
Rifampicin (Rif) and Isoniazid (Inh) are two most crucial drugs in the treatment of first line
tuberculosis (TB) [1]. India ranks second in the world with about total 11% TB cases worldwide
and being one of the major causes of mortality [2]. Therapeutic Drug Monitoring (TDM) is aroutinely practiced clinical laboratory technique which aids the clinicians with a clear clinicaljudgment of the drug therapy and optimize the doses if necessary. Bioavailability andpharmacokinetics of drugs alter their plasma levels in the body. Several factors like age, weight,
gender, doses and formulations, gastro-intestinal disorders, ethnicity etc alter the absorption andbioavailability of rifampicin thus altering the drug levels [1,3,4]. Low plasma levels of rifampicin may
play a plausible role in slow response to therapy, treatment failure or relapse or acquired drug
resistance.

Mechanism of action and Pharmacokinetics of both the drugs

Rifampicin: Rifampicin is a critical and potent component of first-line TB therapy having uniqueproperties of a rapid onset action once in contact with M. tuberculosis [5]. Rifampicin inhibits
bacterial DNA-dependent RNA synthesis by inhibiting bacterial DNA-dependent RNA polymerase.
RNA synthesis is blocked due to inability of the phosphodiester bond formation in the RNA
backbone, preventing extension of RNA products beyond a length of 2-3 nucleotides ("stericocclusion" mechanism). Resistance to rifampicin arises from mutations that alter residues of therifampicin binding site on RNA polymerase, resulting in decreased affinity for rifampicin. Resistantmutations map to the rpoB gene, encoding RNA polymerase beta subunit [6]. It is absorbed fromthe gastro-intestinal (GI) tract in an acidic condition and the rate of absorption is most variable
amongst all TB drugs. Following an oral dose, the peak levels (time to attain maximum
concentration – tmax) are attained within 2 hours however in cases of delayed absorption, tmax
may be attained in 6 hours post dose. [1,4] The peak levels (Cmax) and tmax are delayed inpresence of high-fat meals, so the drug should be given on empty stomach whenever possible. Itsabsorption is fairly reduced in fixed dose combinations with isoniazid and pyrazinamide[3,7].
The half-life of rifampicin is 2- 3 hours [8]. Rifampicin induces its own hepatic metabolism andhence the Cmax and t1/2 of rifampicin decrease over the first two weeks of therapy [5,7].
Therefore, patients on longer than 3 weeks of rifampicin levels tend to have lower rifampicin levels
than their initial baseline values.
Isoniazid: Isoniazid is approved for latent and active tuberculosis infections. In active TB treatment,
it is used in combination with other anti-TB medications to limit drug resistance. Isoniazid is a63
prodrug and must be activated by a bacterial catalase- peroxidase enzyme– KatG in the
Mycobacterium tuberculosis. [9] KatG couples the isonicotinic acyl with NADH to form
isonicotinic acyl-NADH complex. This complex inhibits the synthesis of mycolic acid, required forthe mycobacterial cell wall via the InhA, an enoyl acyl carrier protein reductase. Isoniazid isbactericidal to rapidly dividing mycobacteria, but is bacteriostatic if the mycobacteria are slowgrowing.
It is rapidly and completely absorbed from the GI tract after oral administration with a tmax within
1-2 hours [4]. It is widely distributed in the body and reaches therapeutic concentrations inserum, cerebrospinal fluid, and within caseous granulomas. Plasma half-life in adults is 1 to 4 hours,
depending on metabolic rate. It is metabolized by a hepatic enzyme N-acetyl transferase (NAT2)
via acetylation. Two forms of the enzyme are responsible for acetylation to form a major
metabolite AcINH which has no anti-tubercular activity and is far less toxic than INH.

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APFCB News2015 Features
Formation and elimination of AcINH is genetically controlled, and hence its elimination profile isdependent on phenotype of acetylation i.e rapid, intermediate or slow acetylation [10]. The
NAT2 acetylator phenotype can be inferred from NAT2 genotype (a combinationof SNPs observed in a given individual) into rapid, intermediate, and slow acetylator phenotypes.
Polymorphisms in NAT2 are also associated with higher incidences of cancer and drug toxicity [4].
Slow acetylation, which is transmitted as an auto somal recessive trait, increases the risk forperipheral neurotoxicity and hepatotoxicity in INH users. Study reports have shown theprevalence of NAT2 polymorphisms amongst Indians with ~ 55% slow acetylators, 32%
intermediate & 13% rapid acetylators [11]. Also a high prevalence of slow acetylators is seenamongst Indian Muslims while fast acetylators amongst South Indians [12]. There are numerous
reports available which show the influence of NAT2 genotype on isoniazid levels explaining thevariability in plasma isoniazid levels seen in different populations [10-14]. The metabolites are
excreted in the urine. Doses do not usually have to be adjusted in case of renal failure.
Drug – drug interactions play an important role in treatment regimen and hence need closemonitoring. Isoniazid and rifampicin also exhibit a drug-drug interaction thus reducing rifampicin
exposure / bioavailability in extended presence of isoniazid. Rifampicin on hydrolysis forms 3formyl rifamycin which actively binds to isoniazid in a second order reaction to form isonicotinyl
hydrazine. This hydrazine is an inactive compound thus reducing the bioavailability of rifampicin[15]. Thus dosing formulations should be closely monitored in patients on combinations doses.
Singh N, Dubey S, Chinnaraj S, Golani A, Maitra A. Study of NAT2 Gene Polymorphisms in an
Indian Population. Mol Diag Ther. 2009;13(1):49-58

61

1.

Lakkakula S, Mohan Pathapati R, Chaubey G, Munirajan A, Lakkakula B, Maram R. NAT2
genetic variations among South Indian populations. Hum Gen Variation. 2014;1:14014

2.

Zabost A, Brzezińska S, Kozińska M, Błachnio M, Jagodziński J, Zwolska Z et al. Correlationof N-Acetyltransferase 2 Genotype with Isoniazid Acetylation in Polish Tuberculosis Patients.
BioMed Research International. 2013;2013:1-5.

3.

Kinzig-Schippers M, Tomalik-Scharte D, Jetter A, Scheidel B, Jakob V, Rodamer M et al.
Should We Use N-Acetyltransferase Type 2 Genotyping To Personalize Isoniazid Doses?.
Antimicrobial Agents and Chemotherapy. 2005;49(5):1733-1738.

4.

Singh S, Marriapan T.T, Sharda N, Kumar S, Chakraborti A. The Reason for an increase in
Decomposition of Rifampicin in the presence of isoniazid under acid conditions. Pharm
Pharmacol Commun 2000, 6, 405-410.

5.

Van Crevel R, Alisjahbana B, de Lange WC, Borst F, Danusantoso H, van der Meer JW,
Burger D, Nelwan RH. Low plasma concentrations of rifampicin in tuberculosis patients inIndonesia. Int J Tuberc Lung Dis. 2002;6(6):497-502.

6.

Fahimi F, Tabarsi P, Kobarfard F, Bozorg B, Goodarzi A, Dastan F et al. Isoniazid, rifampicin
and pyrazinamide plasma concentrations 2 and 6 h post dose in patients with pulmonary
tuberculosis. Int J Tuberc Lung Dis. 2013;17(12):1602-1606.

7.

Abou-Auda HS (2014) Possible Interethnic Differences in Rifampin Pharmacokinetics:
Comparison of Middle Eastern Arabs With Other Populations. Adv Tech Biol Med 2014;
1:112. doi: 10.4172/atbm.1000112

8.

Prahl J, Johansen I, Cohen A, Frimodt-Moller N, Andersen A. Clinical significance of 2 h
plasma concentrations of first-line anti-tuberculosis drugs: a prospective observational study.
Journal of Antimicrobial Chemotherapy. 2014; 69(10):2841-7.

9.

Um S-W, Lee S-W, Kwon S.Y, Yoon H.I., Park K.U, Song J et al. Low serum concentrationsof anti-tuberculosis drugs and determinants of their serum levels. Int J Tuber Lung Dis
2011;11(9):972-978

Features

APFCB News 201510. Babalık A, Ulus I, Bakirci N, Kuyucu T, Arpag H, Dagyildiz L et al. Pharmacokinetics andserum concentrations of antimycobacterial drugs in adult Turkish patients. The
International Journal of Tuberculosis and Lung Disease. 2013;17(11):1442-1447.
11. P. K. Chawla, R. V. Lokhande, P. R. Naik, A. J. Dherai, R. A. Amale, Z. F. Udwadia, A.
A. Mahashur, R. Soman, T. F. Ashavaid. Therapeutic Drug Monitoring of Rifampicin andIsoniazid: An Indian Perspective. Ind J Clin Biochem 2015;30 (Suppl 1): S114-S115
12. Gurumurthy P, Ramachandran G, Hemanth Kumar A, Rajasekaran S, Padmapriyadarsini
C, Swaminathan S et al. Decreased Bioavailability of Rifampin and Other
Antituberculosis Drugs in Patients with Advanced Human Immunodeficiency Virus
Disease. Antimicrobial Agents and Chemotherapy. 2004;48(11):4473-4475.
13. Arya A, Roy V, Lomash A, Kapoor S, Khanna A, Rangari G. Rifampicin pharmacokinetics
in children under the Revised National Tuberculosis Control Programme, India, 2009.
Int J Tuberc Lung Dis. 2015;19(4):440-445.
14. Mukherjee A, Velpandian T, Singla M, Kanhiya K, Kabra S, Lodha R. Pharmacokinetics ofisoniazid, rifampicin, pyrazinamide and ethambutol in Indian children. BMC Infect Dis.
2015;15(1).

62APFCB News 2015

Book Review

BOOK REVIEW
CLINICAL CASES IN LABORATORY MEDICINE
Jane French, Beverly Harris and William Marshall
Published by ACB Venture Publications, Oct 2014 (a publication of the Association ofClinical Biochemists, UK), 194 pages, ISBN 978-0-902429-56-7, EAN 9780902429567
Traditionally, the laboratory has produced results with reference intervals to guideinterpretation. The pathophysiological interpretation has been mostly left to the attending
doctor and there is no mandatory requirement for comments on results, even for theabnormal ones. Increasingly, however, the laboratories now append a comment to results
when it is felt that this would help. This practice adds value to the result. While there is someevidence that comments have an impact on patient-care (1, 2), there have been veryfew
studies of its value and clearly more are required.
It is important that comments should reflect accepted practice and current knowledge andguidelines. Often, they do not. Indeed, there is a perception that there is much room for
improvement as seen from the responses in QA programmes on result commentary. It has
been of concern that a large proportion of comments seen in these in QAPs were considered
to be inappropriate and even misleading (3).
Therefore, CLINICAL CASES IN LABORATORY MEDICINE is a book whose time has comesince there are hardly any books purely dedicated to the interpretative commentary of results
in clinical chemistry. It contains 80 cases largely drawn from the UKNEQAS for Interpretative
Comments. A list of reference intervals for the common analytes (intervals for the uncommon
analytes are given where appropriate in the individual cases) and references for each scenario
are provided in the appendices.
While many of the cases are straightforward, some of them have esoteric diagnoses. The
format of the book consists of a short scenario for each case, followed by a set of laboratory
data. There follows a question or questions designed to encourage the reader to consider the
information from the perspective of the requesting clinician and then provide comment on theappropriate course of action to take. One of the authors has previously said that a goodcomment, should aim to answer the enquiring doctor‟s stated or implied question, indicate
the possible significance of the results and perhaps suggest a response such as further
investigation or referral (4).
While each case in the book begins on a fresh page, it is often much less than a page in length.
This format has meant that a lot of space is wasted on the page containing the casedescription. The case commentary is given on the reverse page. Presumably this is to
discourage the reader from falling to the temptation of reading the discussion before trying tofigure it out. The commentary contains issues raised by the case together with options forfurther investigations and management of the patient and key learning points, all squeezed intoa single page. The need to cram the commentary into a single page has resulted in a smaller
sized font being used to accommodate it into a single page. It would have been better if thesame font size was used throughout the book and the commentary simply followed the casepresentation without any waste of space.
This book is yet again another contribution from that excellent series of publications of the
ACB. Besides the practicing clinical biochemist, it will be useful to anyone involved with clinicalbiochemistry, including undergraduate or postgraduate students.

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Book Review

APFCB News 2015

While a wide range of cases is presented, almost all are based on clinical problems. However,unusual results can sometimes occur due to problems in the pre-analytical phase of testing. It is
hoped that the authors will present in future editions scenarios that address problems in thisimportant part of laboratory investigation.
Joseph Lopez
Kuala Lumpur, Malaysia.

References
1.

Kilpatrick ES. Can the addition of interpretative comments to laboratory reports
influence outcome? An example involving patients taking thyroxine. Ann
ClinBiochem2004; 41: 227–229.
2. Bell DA, Bender R, Hooper AJ, McMahon J, et al. Impact of interpretative commenting
on lipid profiles in people at high risk of familial hypercholesterolaemia. ClinChimActa
2013; 422: 21–25.
3. Lim EM,Sikaris KA,Gill J,Calleja J, et al. Quality Assessment of Interpretative
Commenting in Clinical Chemistry. ClinChem2004; 50:3 632– 637.
4. Marshall W. Read the Question Carefully Before You Write Your Answer! ACB News
Issue 576.April 2011.

(The above book review was first published in the November 2015 issue of the eJIFCC andis reproduced here with the kind permission of its Editor-in-Chief Professor GL Kovacs)

64

APFCB News 2015 APFCB Travel AwardAPFCB Travel Award- 53rd Annual Scientific
AACB Conference
Travel Award ReportIt‟s with great pleasure that I write this letter to thank the committee members of APFCB for
bestowing the „APFCB Travel Award‟, which enabled me to attend the Annual AACB
conference in Sydney.

Personally, it was an enriching experience to meet fellow biochemists, and witness therepertoire of work in the field of Clinical Biochemistry. I enjoyed every aspect of theconference. All the symposiums were engaging. I was literally rushing from one room to theother in order to attend the best of the concurrent sessions. Core biochemical concepts likediabetic hyper lipidemia, metabolic bone disease and pheochromocytomas were reviewed andrefreshed. The debate between A/Prof Graham Jones and Prof Richard MacIssac was arefreshing change in the normal proceedings. The focus on upcoming topics as evidenced by
the good selection of „hot topics‟ from the poster presentations and molecular advances wasvery enlightening. The QAP Clinical Cases discussion was an engrossing cheerful session foryoung biochemists like us, which I thoroughly enjoyed.

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APFCB Travel Award

Corporate
APFCB News2015 CornerSocially, apart from the delicious cuisine and drinks, the friendliness of the delegates andprofessors was much appreciated. I made some new friends and caught up with old ones.
We compared notes on prevailing laboratory conditions in different countries. These
interactions have provided me with ideas to implement international best practices in local
setups.
Finally, I thank AACB for the opportunity to showcase my work in the poster session.
Looking forward to meeting everyone next time round.

By: Sudhesna Mohapatra

As my first travel grant, this opportunity is really important to me. Not only because I haveto bring my poster here, but also this will be my chance to make my laboratory more wellknown in other country and to widen my networking as well. Since my laboratory isdeveloping mass spectrometry recently, I learn much about mass spectrometry applicationin this conference and I met many experts in this field which are very welcome and withgeneriously share their experience. Besides the presentation, I enjoyed the passport games
and gala dinner as well. The committee knew really well how to be serious and have fun in
the same time. I really had a good time in Sydney and would like to thank for APFCB, AACB
and all the participants for this wonderful experiences. As Dr. Tina said in closing ceremony,
I hope more scientists will encourage to join this program in the future and have goodexperiences like I did.

By: Jinia Lilianty

APFCB News 2015

66

The Value of a Standardized and Certified
Vitamin D Total Assay for Clinical Confidenceby Spears R, Parker N, Freeman J, Wilson K, Sibley P, Molinaro R. Siemens
Healthcare Diagnostics Inc., Tarrytown, New York, USA

Abstract
Background: Vitamin D is a steroid hormone involved in the intestinal absorption of calcium
and the regulation of calcium homeostasis. Standardization of vitamin D assays in laboratory
medicine has become increasingly important. Apart from being able to assess the vitamin D
status of an individual, standardization is necessary to accurately determine theconcentration of vitamin D in patients on supplementation. The Siemens ADVIA Centaur®
Vitamin D Total assay has been standardized to the University of Ghent ID-LC/MS/MS
reference measurement procedure (RMP) and has achieved the Centres for Disease Control(CDC) Vitamin D Standardization Certification (VDSCP). Assay performance has beenassessed in patient samples and compared to a VDSCP-certified LC-MS/MS assay. In
addition, samples containing 25(OH)vitamin D2 and 25(OH)vitamin D3 were included in the
study to demonstrate the ability of the assay to measure both forms of 25(OH)vitamin D
and also to demonstrate the equimolarity of the test.
Method: A comparison between the ADVIA Centaur Vitamin D Total assay and the
Endocrine Sciences Laboratory (LabCorp, Calabasas Hills, CA) VDSCP-certified 25(OH)vitamin D LC/MS/MS method was achieved by running 149 samples across the range of bothmethods. The samples were tested using the ADVIA Centaur Vitamin D Total assay andsubsequently run on Lab Corp‟s VDSCP certified method. These data were analyzed with aDeming fit comparison plot as well as a Bland-Altman plot comparing the total vitamin D
dose data between the two methods. both 25(OH)vitamin D2 and D3 and for samples
containing 25(OH )vitamin D3 only in order to assess the assay‟s equimolarity.
Results: The data obtained showed good correlation between the ADVIA Centaur Vitamin
D Total assay and the VDSCP-certified 25(OH) vitamin D LC/MS/MS method. The Deming
fit comparison between the two methods yielded a Deming slope of 0.97, an intercept of
2.22 ng/mL, and a Pearson‟s coefficient of 0.95. When focusing specifically on the 55 samples
containing 25(OH) vitamin D2 , the Deming slope was 1.02, with an intercept of 1.92 ng/mL
and a Pearson‟s coefficient of 0.93. When analyzing the 94 samples that contain only 25(OH) vitamin D3, the Deming slope was 0.95, with an intercept of 2.13 ng/mL and a Pearson‟scoefficient of 0.97.
Conclusions: In comparison to a VDSCP-certified 25(OH) vitamin D LC/MS/MS method, the
ADVIA Centaur Vitamin D Total assay produced comparable results across the full range ofthe assay and was able to accurately measure both forms of 25(OH) vitamin D. These data
indicate the importance of standardization to improve clinical confidence in thecomparability of vitamin D measurement.

Method and Results
The ADVIA Centaur Vitamin D Total assay successfully passed the performance criterion for
total 25(OH) vitamin D VDSCP certification. The performance specified for total
25(OH)vitamin D VDSCP includes a •}5% bias to the CDC and University of Ghent Vitamin
D2 and D3 RMP and an overall imprecision of ≤10% between 8.8 and 110 ng/mL. The
Endocrine Sciences Laboratory (Esoterix, Endocrine Sciences, Calabasas Hills, CA)
LC/MS/MS method has also been certified. It is important to evaluate patient samples
similarly across platforms and locations, so in order to further evaluate the harmonization
between different certified methods; a method comparison was performed between the
ADVIA Centaur Vitamin D Total assay and the Endocrine Sciences Laboratory LC/MS/MS
method.

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Corporate Corner

APFCB News 2015

Unknown patient samples were tested in singleton with one lot of reagent on the Siemens
ADVIA Centaur Vitamin D Total assay. After testing, samples were selected across therange of the assay and sent to Lab Corp for further testing on their 25(OH)vitamin D
LC/MS/MS method. The comparison of total vitamin D values between both methods isshown in Figure 1; the residual plot is shown in Figure 2. The Deming fit shows goodalignment between the two methods, with a Deming slope of 0.97, intercept of 2.22
ng/mL, and a Pearson‟s coefficient of 0.95, as shown in Table 1. An Altman Bland bias plotthat shows minimal bias was also generated for all samples tested across the range todemonstrate the correlation between methods, as shown in Figure 3.
Figure 1. Deming fit for the ADVIA Centaur Vitamin D Total assay dose versus thecorresponding Endocrine Sciences Laboratory dose.

Figure 2. Residual plot between ADVIA Centaur Vitamin D Total assay versus thecorresponding Endocrine Sciences Laboratory LC/MS/MS method.

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APFCB News 2015

Corporate Corner

Figure 3. Altman Bland bias plot between all samples run on the ADVIA Centaur Vitamin D
Total assay and Endocrine Sciences Laboratory LC/MS/MS method.

Two forms of vitamin D are metabolized in the body. Vitamin D3 is found naturally in thebody, derived from the irradiation of pro vitamin 7-dehydrocholesterol in the skin. Vitamin D2
can be obtained through diet from sources such as fish and plants. These two forms of vitamin
D are metabolized by the body to produce 25(OH)vitamin D2 and 25(OH)vitamin D3, both ofwhich have similar biological activity. Since vitamin D3 is the form that occurs naturally in thebody, the normal population has more 25(OH) vitamin D3 than 5(OH)vitamin D2. However,patients who test low for vitamin D are advised to add a supplemental source of vitamin D totheir diet, which can elevate either 25(OH) vitamin D2 or 25(OH) vitamin D3 levels. Since thetwo metabolite forms are biologically similar, it is important for an assay to detect both forms
equally. The Endocrine Sciences Laboratory 25(OH) vitamin D method employs LC/MS/MS
and can determine separate values for 25(OH) vitamin D2 and 25(OH) vitamin D3. Samples
that contained 25(OH) vitamin D2 when tested by the Endocrine Sciences Laboratory method
were plotted against the ADVIA Centaur Vitamin D Total assay to ensure the assay‟sequimolarity and that there was no bias between the two forms. The comparison of samples
containing vitamin D2 between the two methods is shown in Figures 4 and 5, and thecomparison of samples only containing vitamin D3 is shown in Figures 7 and 8. An Altman
Bland bias plot for the two forms can be seen in Figures 6 and 9, respectively.
Figure 4. Deming fit for the ADVIA Centaur Vitamin D Total Assay dose versus thecorresponding Endocrine Sciences Laboratory dose for samples containing vitamin D2.

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Figure 5. Residual plot for the ADVIA Centaur Vitamin D Total assay dose versus thecorresponding Endocrine Sciences Laboratory dose for samples containing vitamin D2.

Figure 6. Altman Bland bias plot between vitamin D2 samples run on the ADVIA Centaur
Vitamin D Total assay and Endocrine Sciences Laboratory 25(OH)vitamin D assay.

Figure 7. Deming fit for the ADVIA Centaur Vitamin D Total assay dose versus thecorresponding Endocrine Sciences Laboratory dose for samples containing vitamin D3.

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Figure 8. Residual plot for the ADVIA Centaur Vitamin D Total assay dose versus thecorresponding Endocrine Sciences Laboratory dose for samples containing vitamin D3.

Figure 9. Altman Bland bias plot between vitamin D3 samples run on the ADVIA Centaur
Vitamin D Total assay and Endocrine Sciences Laboratory 25(OH)vitamin D assay.

As shown in Table 1, the methods are harmonized regardless of whether the sample contains
vitamin D3 only or both vitamin D3 and vitamin D2.
Table 1. Deming line equation and Pearson‟s coefficient statistic summary for ADVIA
Centaur Vitamin D Total assay dose versus Endocrine Sciences Laboratory dose.

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Conclusion: The alignment of the Siemens ADVIA Centaur Vitamin D Total assay to the

CDC and University of Ghent Vitamin D2 and D3 RMP provides laboratories with astandardized method to tests patients for total 25(OH) vitamin D levels. In this study, themethod comparison of the Siemens ADVIA Centaur Vitamin D Total assay to anothermethod that is also traceable to the CDC and University of Ghent Vitamin D2 and D3 RMP
demonstrates that having assay methods align to a single standard leads to accurate andreliable results for patients, regardless of the test performed. The data in this study shows
clinical confidence in the comparability of vitamin D measurements between methods andthat the automated Siemens ADVIA Centaur Vitamin D Total assay measures both forms of25(OH) vitamin D equally and provides laboratories with a high through put, standardized
assay.

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Performance and Certification of the ADVIA Centaur
Vitamin D Total Assayby Spears R, Parker N, Freeman J, Wilson K, Sibley P.Siemens Healthcare Diagnostics Inc.,
Tarrytown, New York, USA

Abstract
Background: Vitamin D helps regulate calcium in the development and maintenance of healthybones. The National Institutes of Health Office of Dietary Supplements created the Vitamin D
Standardization Program (VDSP) to establish a standard for accurate and comparable results for thedetection of 25(OH)D across laboratories. Siemens Healthcare Diagnostics enrolled in the VDSP to
produce a harmonized industry standard for 25(OH)D testing.

Method: Between January and December 2013, the Centers for Disease Controls (CDC)

provided 40 blinded 25(OH)D samples to the Vitamin D Standardization- Certification Program(VDSCP), in which a set of 10 samples with Reference Measurement Procedure (RMP) values wasevaluated each quarter. Samples were tested blindly in replicates of four over 2 days, two
replicates per day. Additional supplemental samples were also evaluated, including the fourstandards from the National Institute of Standards and Technology (NIST).

Results: The ADVIA Centaur R Vitamin D Total assay met the criteria for VDSCP certification. The
mean bias to the reference method was 0.3%, within the acceptable bias of ±•-}5.0%. The assays
imprecision of 5.5% was also within the acceptable range of ≤10.0%. A linear regression of theblinded samples demonstrates a slope of 1.01 and an intercept of −1.89 nmol/L. The ADVIA
Centaur Vitamin D Total assay also shows an acceptable bias with the NIST Standard Reference
Material (SRM) 972a vitamin D metabolite samples.

Conclusions: The VDSCP certification for the ADVIA Centaur Vitamin D Total assay establishes

an acceptable alignment to a harmonized testing standard for 25(OH)D. The ADVIA Centaur
Vitamin D Total assay provides laboratories with a standardized and automated means for quickly
and efficiently testing patients‟ 25(OH)D levels.

Introduction

The Vitamin D Standardization Program (VDSP) is an initiative to standardize 25(OH)vitamin D
measurements using a Reference Measurements Procedure. There are two RMPs approved as partof the VDSP: (1) NIST and (2) Ghent University. These values are treated as “true” values to which
25(OH)vitamin D assay manufacturers can harmonize their assays1,2. 25(OH)vitamin D methods
are challenged by the DC‟s Vitamin D Standardization Certification Program (VDSCP) to obtain ayearly certification as well as monitored by performance testing surveys and external quality
assessments, such as CAP and DEQAS.
The CAP survey samples have the values assigned by the CDC laboratory, which is traceable to the
NIST RMP, and the DEQAS survey samples have the values assigned directly by NIST RMP. The
RMP is also the primary method employed for use with vitamin D reference materials, such as NIST
Standard Reference Materials® (SRM) 972a4.
Figure 1. Linear regression analysis of the reference value(nmol/L) versus the sample value (nmol/L)by the ADVIA Centaur Vitamin D Total assay. Data was analyzed using CLSI EP9-A2 section 4.2 B1.

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Figure 2. Precision of the ADVIA Centaur Vitamin D Total assay based on the reference
value (nmol/L).

In order to assure consistency across assays, the VDSP program ties these true values toproficiency testing, such as CAP and DEQAS, as well as the NIST SRM. Siemens Healthcare
Diagnostics tested the ADVIA Centaur Vitamin D Total assay with SRM 972a control materials
and demonstrated similar results to the RMP, as seen in Table 3.
Table 3. Comparison of 25(OH)Vitamin D reference values (nmol/L) versus ADVIA Centaur
XP (nmol/L). Yellow cells indicate reference values, and the other cells represent certified
values, which are values for which NIST has the highest confidence in accuracy.

Table 4 shows the ADVIA Centaur Vitamin D Total assay results from a recent DEQAS survey
in comparison to the target value. The DEQAS survey provides five samples that are shipped
quarterly. The samples are unprocessed human serum and value-assigned by the NIST
Reference Measurement Procedure. These data clearly show that the assay is performing
acceptably in laboratories worldwide, as each sample is within at most 6% of the target.

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Table 4. January 2015 DEQAS Survey samples comparing the reference method, NIST, to theaverage of all Siemens ADVIA Centaur Vitamin D Total assay participant values in the survey.

The ADVIA Centaur® Vitamin D Total assay shows good alignment to the “true” reference
method, as seen in Figure 1. The method comparison demonstrated a slope of 1.01 and anintercept of −1.89 nmol/L. Also, the samples showed good correlation between methods,
with an R of 0.95.
Table 1. Bias assessment of each sample in comparison to the reference value. Mean bias wasderived from the individual sample bias for each of the 40 samples.

Table 1 shows the overall bias (0.3%) and 95% confidence interval for that bias, which is 5.0% and 5.6%. As demonstrated through the certification process, it is clear that the ADVIA
Centaur Vitamin D Total assay is within the acceptable specifications.
As seen in Table 2 and Figure 2, the ADVIA Centaur Vitamin D Total assay passed the CV
requirements, demonstrating a mean CV of 5.5%, which was below the acceptance criteria of
10%.
Table 2. Summary of precision data from the 40 individual serum samples tested by Siemens
Healthcare Diagnostics.

Figure 2. Precision of the ADVIA Centaur Vitamin D Total assay based on the reference value(nmol/L).

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Conclusion
Having passed the acceptance criteria for the Vitamin D Standardization Certification Program,and demonstrating good alignment and correlation with the ndustrystandard Reference Method
Procedures, the Siemens Healthcare Diagnostics Vitamin D Total assay provides laboratories
with a quick and efficient method to accurately measure patients‟ 25(OH)vitamin D levels.

References
1.

Sempos CT, Vesper HW, Phinney KW, Thienpont LM, Coates PM, Vitamin D
Standardization Program (VDSP).Vitamin D status as an international issue: National
surveys and the problem of standardization. Scandinavian Journal of Clinical & Laboratory
Investigation, 2012; 72(Suppl 243): 32–40

2.

Thienpont L, Stepman HCM, Vesper HW. Standardization of measurements of 25Hydroxyvitamin D3 and D2. Scandinavian Journal of Clinical & Laboratory Investigation,
2012; 72 (Suppl 243): 41–49

3.

Vitamin D Standardization Program (VDSP). (n.d.). Retrieved 2015, fromhttp://ods.od.nih.gov/Research/vdsp.aspx

4.

NIST Material Measurement Laboratory Standard Reference Materials CoA 972a. (2013,
February 20). Retrieved 2015, from https://www-s.nist.gov/srmors/certificates/
view_certGIF.cfm?certificate=972a

5.

Vesper, H., & Botelho, J. (2014, March 27). Vitamin DStandardization Program.
Standardization of the total serum25-hydroxyvitamin D measurements. Retrieved 2015
fromhttp://www.cdc.gov/labstandards/pdf/hs/Vitamin_D_Protocol.pdf

Background
The Vitamin D Standardization Program (VDSP) is an initiative to standardize 25(OH)vitamin D
measurements using a Reference Measurements Procedure. There are two RMPs approved aspart of the VDSP: (1) NIST and (2) Ghent University. These values are treated as “true” values towhich 25(OH)vitamin D assay manufacturers harmonize their assays, allowing more trust in the25(OH)vitamin D values from laboratories worldwide. 5(OH) vitamin D methods are challenged
by the CDC‟s Vitamin D Standardization Certification Program (VDSCP) to obtain a yearlycertification as well as monitored by performance testing surveys and external quality
assessments, such as CAP and DEQAS. CAP survey samples have the values assigned by the
CDC laboratory, which is traceable to the NIST RMP and DEQAS samples are value assigned
directly by NIST. The RMP is also the primary method employed for use with vitamin D
reference materials, such as NIST SRM 972a. The CDC has provided single-donor serum
samples that have value-assigned concentrations by the Ghent University RMP.
.
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Corporate CornerWith these samples, Siemens Healthcare Diagnostics performed a method comparison between
the ADVIA CentaurR Vitamin D Total assay and the RMP. In order to demonstrate harmonization,
Siemens has performed a method comparison between the ADVIA Centaur Vitamin D Total assay
and another assay that has also been aligned to the Ghent University RMP.

Methods and Results

118 samples with true RMP values were assessed by Siemens with a method comparison todemonstrate alignment between the RMP values and the ADVIA Centaur Vitamin D Total assay.
These data were analyzed with a Deming fit, residual plot, and Altman Bland difference plot toshow the alignment between the two methods.
Figure 1 shows good correlation between the reference method and the ADVIA Centaur Vitamin
D Total assay. The Deming fit has a slope of 0.95 and an intercept of 1.62 ng/mL. The residual andBland Altman bias plots of the data in Figures 2 and 3, respectively, show minimal bias between
the sample values for the two methods.
A method comparison was also performed with another CDC VDSCP-certified assay containing
samples that span a range from 4.2 to 152 ng/mL. As seen in Figure 4, thismethod comparison results in a Deming slope of 0.99 with an intercept of 1.17 ng/mL, evidence
that the two assays are harmonized and aligned to the true assigned values. The residual plot
(Figure 5) and the Altman Bland bias plot (Figure 6) also support the alignment of these two assays
by demonstrating minimal bias. If all vitamin D methods were aligned to the RMP, as these two
assays are, it would allow uniform decisions based on the patient‟s 25(OH)vitamin D level, sincepatients will receive similar values regardless of where and which laboratory tested their blood
sample.
The data compiled in Table 1 as well as the corresponding figures shows good correlation to thetrue RMP values and to another CDC VDSCP-certified assay. Clinicians can haveconfidence in the values reported by assays that have been CDC VDSCP-certified, such as the
ADVIA Centaur Vitamin D Total assay.
Figure 1. Deming fit for the ADVIA Centaur Vitamin D Total assay versus the corresponding
CDC-RMP–assigned values.

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Figure 2. Residual plot between the ADVIA Centaur Vitamin D Total assay dose and thecorresponding CDC-RMP dose.

Figure 3. Altman Bland bias plot between all samples run on the ADVIA Centaur Vitamin D
Total assay and CDC-RMP.

Table 1. Summary of method comparison

Figure 4. Deming fit for the ADVIA Centaur Vitamin D Total assay versus the corresponding
IDS 25-Hydroxy Vitamin D EIA values.

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Figure5. Residual plot for the ADVIA Centaur Vitamin D Total assay dose and thecorresponding IDS 25-Hydroxy Vitamin D EIA assay dose.

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Figure 6. Altman Bland bias plot between all samples run on the ADVIA Centaur Vitamin D
Total assay and IDS 25-Hydroxy Vitamin D EIA assay.

Conclusion

The Siemens ADVIA Centaur Vitamin D Total assay is a CDC VDSCP-certified assay that
demonstrates good alignment to both the RMP method and another CDC VDSCP-certified
assay. At the time of publication, both assays had received their second year of certification. The
harmonization between the ADVIA Centaur Vitamin D Total assay and the true RMP values for25(OH) vitamin D ensures accurate and reliable results.

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