World Health Organization Model List of
Essential In Vitro Diagnostics
First edition (2018)

November 2018

Table of contents

Acronyms................................................................................................................................. 2
Preface .................................................................................................................................... 3
List of Essential In Vitro Diagnostics (EDL) ....................................... Error! Bookmark not defined.
I List of Essential In Vitro Diagnostics (EDL): For primary health care Error! Bookmark not defined.
I.a General IVDs for primary health care ...................................... Error! Bookmark not defined.
I.b Disease-specific IVDs for primary health care .......................... Error! Bookmark not defined.
II List of Essential In Vitro Diagnostics (EDL): For health care facilities with clinical laboratories...................................................................................................... Error! Bookmark not defined.
II.a General IVDs for health care facilities with clinical laboratories ........... Error! Bookmark notdefined.
II.b Disease-specific IVDs for health care facilities with clinical laboratories ..... Error! Bookmark
not defined.

Department of Essential Medicines and Health Products
World Health Organization
20 Avenue Appia
CH-1211 Geneva 27
Switzerland1E-mail: edlsecretariat@who.int
http://www.who.int/medical_devices/diagnostics/Selection_in-vitro_diagnostics

2

Acronyms
ALT
AMR
AST
BMP
BUN
CBC
CLIA
CRP
CSF
CVD
DST
ECL
EDL
eGFR
EIA
ELISA
EML
EPTB
GPW
Hb
HbA1c
hCG
Ht
HTLV
IGRA
INR
IVDs
LAMP
LPA
NAT
NCDs
PQ
PT
RBC
RDT
SAGE-IVD
TB
TST
UTI
VHF
WBC
WHO

alanine aminotransferase
antimicrobial resistanceaspartate aminotransferase
basic metabolic panel
blood urea nitrogencomplete blood countchemiluminescence immunoassay
C-reactive protein
cerebrospinal fluid
cardiovascular diseasedrug susceptibility testing
electrochemiluminescence
World Health Organization Model List of Essential In Vitro
Diagnostics
estimated glomerular filtration rate
enzyme immunoassay
enzyme linked immunosorbent assay
World Health Organization Model List of Essential
Medicines
extrapulmonary tuberculosis
WHO General Programme of Work
haemoglobin
haemoglobin A1chuman chorionic gonadotropin
haematocrit
human T-lymphotropic virusinterferon gamma release assay
international normalized ratioin vitro diagnostics
loop mediated isothermal amplificationline probe assay
nucleic acid test
noncommunicable diseases
WHO Prequalification
prothrombin time
red blood cell countrapid diagnostic test
Strategic Advisory Group of Experts on In Vitro Diagnostics
Mycobacterium tuberculosis
tuberculin skin test
urinary tract infection
viral haemorrhagic fever
white blood cell countWorld Health Organization

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Preface
Introduction
The World Health Organization (WHO) published the first edition of the Model List of Essential In
Vitro Diagnostics (EDL) in May 2018, in recognition that IVDs are an essential component to advance
universal health coverage, address health emergencies, and promote healthier populations, which
are the three strategic priorities of the WHO Thirteenth General Programme of Work (2019–2023)(GPW). The EDL is also intended to complement the WHO Model List of Essential Medicines (EML)and enhance its impact.

Objectives of the Model List of Essential In Vitro Diagnostics (EDL)The EDL outlines a group of IVDs that are recommended by WHO for use at various levels of a tiered
national health care system. The EDL is not intended to be prescriptive with respect to the IVDs
listed or the levels at which such IVDs can/should be used; rather country programmes should makethe ultimate decisions about which IVDs are selected and where they are implemented, based onnational or regional burden of disease, unmet needs and priorities.
It is expected that the EDL will provide guidance and serve as a reference to Member States(including ministries of health, programme managers, end users such as laboratory managers,
procurement officers and reimbursement systems), who are developing and/or updating lists ofnational essential IVDs for defining universal health coverage interventions, as well as selecting andimplementing such IVDs. It will also inform United Nations agencies and nongovernmentalorganizations that support selection, procurement, supply, donations or provision of IVDs. Finally, it
will inform and guide the medical technology private sector on IVD priorities and the IVDs needed toaddress global health issues.
While the EDL provides a list of important tests required at various levels of the health care system,
it is important to note that the EDL itself cannot have an impact without an integrated, connected,
tiered laboratory system, with adequate human resources, training, laboratory infrastructure, andregulatory/quality assurance systems. Impact also requires Member States to adopt and adapt the
EDL and develop national and regional EDLs, as well as to implement the selection and supply
mechanisms necessary to ensure access to the IVDs.

Scope of the first edition of the EDL
Based on the EDL selection criteria described below, the EDL consists:

A group of general laboratory tests that can be used for routine patient care as well as forthe detection and diagnosis of a wide array of disease conditions – communicable and NCDs.
These IVDs are grouped by test discipline (e.g. clinical chemistry, serology, haematology,
microbiology and mycology) and specific test type (e.g. bilirubin, complete blood count,etc.).
IVDs designed for the detection, diagnosis and monitoring of each of the following WHO key
disease areas: HIV, TB, malaria, HBV/HCV, and HPV and syphilis. These IVDs are grouped bydisease area and analyte tested.

4

The EDL does not list specific test brands, but rather consists of IVDs described according to their
biological targets. Where specific products in categories of tests contained in the EDL have beenprequalified by WHO or are recommended by a WHO disease programme, a link is provided to that
information, which is updated regularly.

EDL content and format
For each specific test listed in the first edition of the EDL, the following are described:








Test purpose:
Assay format:

Purpose for which the test can be utilized.
The assay format or formats in which the test is generally
available, e.g. enzyme immunoassay, nucleic acid testing.
Specimen type:
The types of specimens that can be used for the test.
Facility level:
The level of the tiered health care delivery system for which
the test is suggested, as described below.
Link to WHO guidance:
If there is existing WHO guidance available on the test or
category of testing, a link is provided to the appropriate
location on the WHO website.
WHO PQ or endorsed products: For each specific test for which there are brands of products
either prequalified by WHO or otherwise endorsed by WHO,a link is provided.

The EDL is presented by health care facility level in two tiers:
I IVDs for Primary health care;
II IVDs for Health care facilities with clinical laboratories.

Recommended use of the EDL
In order to effectively use the EDL and adapt it to national needs, WHO recognizes that Member
States will need to consider a variety of factors. These include, among others: local demographics
and burden of disease; local disease elimination priorities; local availability of treatments; training
and experience of available personnel; local unmet needs and testing gaps; supply chain andtransport links; quality assurance capacity; financial resources; information technology capabilities;
and environmental factors.
To that end, information that supports the selection and use of IVDs on the EDL, such as relevant
WHO clinical guidelines, selected systematic reviews, key references, lists of prequalified IVDs and
IVDs recommended by WHO disease control departments, as well as other relevant resources on
quality assurance, basic techniques, procurement and maintenance guidance, will be collated andmaintained on the WHO website on an IVD-specific webpage linked to the EDL.
The EDL should not be used in isolation, but in the context of the scope of testing services that meetthe clinical needs and expectations in each country through their own particular laboratory
networks. An illustrative example of a tiered health care delivery and laboratory network inresource-limited countries is set out in Figure 1. The pyramid of testing reflects that there are
generally a large number of primary care facilities and that they serve most patients directly forprimary care needs. As one goes up the levels of the system, there are a smaller number of5centralized facilities serving fewer patients directly. In the case of national reference laboratories
and some provincial laboratories, they may not serve patients directly or they may offer a broad setof specialist consultative services, and act more as referral centres for quality assurance and training
or for conducting complex tests (either using samples drawn at facilities lower in the system andtransported or by receiving patients referred directly from other facilities).

Figure 1. The types of testing that are appropriate at each tier will be country-specific and will
include, among others, factors such as access to electricity, reagent grade water, phlebotomy andspecialized human resources.1
For purposes of the first edition of the EDL and to simplify its presentation and use, IVDs are listed
for two tiers: primary care settings where no or minimal laboratories are available (Level I in Figure1) or for laboratory-based facilities (Levels II, III, and IV in Figure 1).

Process of development of the first edition of the EDL
In March 2017, the WHO Expert Committee on Selection and Use of Essential Medicines
recommended that an EDL be developed. In support of that recommendation, WHO created an EDL
Secretariat, which drafted the first edition of the EDL in consultation with colleagues in the various
WHO disease programmes. It was then posted online for open consultation. WHO also created aStrategic Advisory Group of Experts on In Vitro Diagnostics (SAGE-IVD) to support the developmentof the EDL and to advise on other IVD policies and initiatives. SAGE-IVD held its first meeting from
16–20 April 2018 at WHO headquarters, Geneva, where it made recommendations for the content,
format and implementation of the first edition of the EDL, as well as its processes moving forward.

Selection of IVDs for inclusion in the first edition of the EDL
The selection of the diagnostics tests for the EDL took into account the following priorities:
1

Adapted from: WHO (2017). Guidance for procurement of in vitro diagnostics and related laboratory items
and equipment (http://www.who.int/diagnostics_laboratory/publications/procurement/en/).

6





IVDs for primary care settings, providing an essential diagnostics package that can form thebasis for screening and case management of patients at entry-level health care facilities.
Public health approach, providing information on access to affordable, quality-assured IVDs,
targeting high burden diseases, both communicable diseases and NCDs, and diseases ofpublic health importance.
IVDs for priority diseases such as HIV, TB, malaria, hepatitis HBV/HCV, and HPV and syphilis
infections.

Specifically, the general laboratory diagnostics in the first edition of the EDL were compiled based on
existing WHO guidance, guidelines and technical manuals and priority medical devices lists, which
are referenced at the end of the list.
The disease-specific IVDs were selected from WHO evidence-based guidelines, which are referred toin the EDL with links to the respective documents. An additional factor considered by WHO was theavailability of evidence from the WHO Prequalification of In Vitro Diagnostics Programme (PQ), orfrom other WHO IVD assessment processes, as applicable, which further support the choice of
certain diagnostic test categories. Links to relevant documents are provided in the EDL by type of
test.

Process for updating the EDL going forward
The EDL will be expanded and updated annually with the intention to ultimately cover a broad,comprehensive spectrum of disease. WHO will issue a call for applications to add IVD test categories
to the next edition of the EDL in mid-2018. The call will request applicants to provide information onclinical accuracy or impact of the proposed IVDs. The first EDL will be expanded significantly over the
next few years, incorporating tests for other important areas such as antimicrobial resistance,
additional NCDs, emerging pathogens, emergencies and outbreaks, and neglected tropical diseases.
It is foreseen that the EDL will be an important tool to increase access to appropriate, affordable,and quality-assured IVDs, particularly where they are most needed to address health priorities.

Relationship between the EDL and List of Prequalified In Vitro Diagnostics
It should be noted that the EDL and PQ List are complementary and distinct. The PQ lists include
priority IVDs which have been assessed by WHO and are identified by brand (in contrast to the EDL
which lists categories of IVDs). Currently the PQL has a narrower scope than the EDL.
Having IVDs on the PQ list is not a requirement for a category of tests to be considered for inclusionin the EDL. In the context of the EDL, the PQ list should be viewed as a resource as it lists specificprequalified brands of products that correspond to certain categories of tests in the EDL. Relevant
links are provided in the EDL.

7

Implementation of the EDL by countries
It will be important that Member States adopt and adapt the EDL to develop their own national
EDLs. These national EDLs will then need to be implemented to ensure impact. Implementation
requires countries to invest in integrated, connected, tiered laboratory systems, with adequate
human resources, training, laboratory infrastructure, and regulatory and quality assurance systems.

Glossary
Essential diagnostics: Diagnostics that satisfy the priority health care needs of the population andare selected with due regard to disease prevalence and public health relevance, evidence of efficacy
and accuracy, and comparative cost-effectiveness; similar to the definition of an essential medicine.
Health care facility with laboratory support: District, regional, provincial or specialized
hospitals/laboratories and national reference laboratories. Trained laboratory technicians, specialist
expertise and laboratory infrastructure/equipment are available at the appropriate level. Note: Alldiagnostic tests available at the primary care level are assumed to be available at higher levels as
appropriate.
In vitro diagnostics: A subset of medical devices, defined as: a device which, whether used alone orin combination, is intended by the manufacturer for the in vitro examination of specimens derived
from the human body solely or principally to provide information for diagnostic, monitoring orcompatibility purposes. It includes reagents, calibrators, control material, test kits, etc.2
Medical device: Any article, apparatus, instrument, machine, appliance, implant, reagent for in vitrouse, software, material or other similar related articles, intended to be used, alone or in
combination, for human beings, for one or more of the specific medical purpose(s) of:








diagnosis, prevention, monitoring, treatment or alleviation of disease;diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
investigation, replacement, modification, or support of the anatomy or of a physiologicalprocess;
supporting or sustaining life;
control of conception;
disinfection of medical devices;
providing information by means of in vitro examination of specimens derived from thehuman body;and does not achieve its primary intended action by pharmacological, immunological or metabolicmeans, in or on the human body, but which may be assisted in its intended function by such means.
Primary health care: Health centres, doctors’ offices, health posts, outreach clinics. Typically, selftesting and rapid diagnostics tests are available, but there are either no laboratories, or smalllaboratories with trained health care personnel but no trained laboratory technicians.

2

Global Harmonization Task Force (2012). Definition of the terms medical device and in vitro diagnostic (IVD)
medical device (http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n071-2012-definition-ofterms-120516.pdf#search, accessed 3 May 2018).

8

Additional materials to assist countries in the selection andimplementation of IVDs
These include, but are not limited to:
WHO website (www.who.int).
Guidance for procurement of in vitro diagnostics and related laboratory items and equipment.
Second edition. Geneva: World Health Organization; 2017(http://www.who.int/diagnostics_laboratory/publications/procurement/en/).
WHO Global model regulatory framework for medical devices including in vitro diagnostic medical
devices. WHO Medical device technical series. Geneva: World Health Organization; 2017(http://www.who.int/medical_devices/publications/global_model_regulatory_framework_meddev/en/).
Consultation on technical and operational recommendations for clinical laboratory testingharmonization and standardization. Geneva: World Health Organization; 2008(http://www.who.int/healthsystems/round9_9.pdf).
Global Health Observatory data data. Geneva: World Health Organization; 2017(http://www.who.int/gho/en/).
WHO guide for the stepwise laboratory improvement process towards accreditation in the African
Region (SLIPTA). Brazzaville: WHO Regional Office for Africa; 2015.
(http://www.afro.who.int/publications/who-guide-stepwise-laboratory-improvement-processtowards-accreditation-slipta-african).
Laboratory quality standards and their implementation. WHO Regional Office for the Western Pacificand WHO Regional Office for South-East Asia; 2011(http://www.who.int/medical_devices/publications/lab_quality_standards/en/).
Guide for national public health laboratory networking to strengthen integrated disease surveillance
and response (IDSR). Brazzaville: WHO Regional Office for Africa; 2008(http://www.afro.who.int/publications/guide-national-public-health-laboratory-networkingstrengthen-integrated-disease).
Guidance for development of national laboratory strategic plans. Brazzaville: WHO Regional Officefor Africa and Atlanta (Georgia): United States Centers for Disease Control and Prevention (CDC);
2009 (http://www.who.int/hiv/amds/amds_guide_dev_nat_lab_strat.pdf).
Guidance for procurement of in vitro diagnostics and related laboratory items and equipment.
Geneva: World Health Organization; 2017(http://www.who.int/diagnostics_laboratory/publications/procurement/en/).
WHO expert meeting report on short, medium and longer term product development priorities in
HIV-related diagnostics. Geneva: World Health Organization; 2012(http://www.who.int/hiv/pub/meetingreports/hiv_diagnostics/en/).
Interagency list of priority medical devices for essential interventions for reproductive, maternal,
newborn and child health; 2015(http://www.who.int/medical_devices/publications/interagency_med_dev_list/en/).
9WHO list of priority medical devices for cancer management; 2017(http://www.who.int/medical_devices/publications/priority_med_dev_cancer_management/en/ ).
WHO publications on medical devices. Geneva: World Health Organization; 2018(http://www.who.int/medical_devices/publications/en/).

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List of Essential In Vitro Diagnostics (EDL)
The first edition of the EDL is presented by health care facility level in two tiers:
I Primary health care; with section a for general IVDs; and section b for specific diseases.

II Health care facilities with clinical laboratories, with section a for general IVDs; and section b for specific diseases.

I List of Essential In Vitro Diagnostics (EDL): For primary health care
Includes IVDs for health posts, community health centres, doctors’ offices, outreach clinics and ambulatory care.
Typically, self-testing and rapid diagnostics tests are available, but there are either no laboratories, or only small laboratories with trained healthcare personnel but no trained laboratory technicians.
In case laboratory facilities are available in a primary health care facility, please refer to the IVDs described in the next tier.
It should be noted that in some cases sampling can take place where there are no laboratories, and then processed in the next tier.
I.a General IVDs for primary health care
Note: See list of WHO supporting documents at the end.
Haematology

Diagnostic test

Test purpose

Assay format

Specimen type

Haemoglobin (Hb)

Diagnosis and monitoring of anaemia
Key clinical marker for severe infections (i.e. malaria, dengue,
VHFs)
Safety monitoring when using certain drugs (e.g. Zidovudine
for HIV)

Haemoglobinometer

Capillary whole blood
Venous whole blood

Dipstick

Urine

Surrogate marker for certain infections, inflammation or
certain cancers (e.g. leukaemia)
To detect anaemia, infections and leukaemia

Haematology analyser

Capillary whole blood
Venous whole blood
Capillary whole blood
Venous whole blood

White blood cellcount
CBC manual (only as
back-up toautomated method)

Haemocytometer (tomeasure WBC) and Wright,
May-Grünwald or Giemsa
stain (for differential
detection of parasites,
malignant cells)
Peripheral blood film
examination

Capillary whole blood
Venous whole blood

11

I.a General IVDs for primary health care
Note: See list of WHO supporting documents at the end.
Clinical chemistry andimmunoassays

Diagnostic test

Test purpose

Assay format

Specimen type

Albumin
Bilirubin

To detect/monitor kidney disease
To detect/monitor liver disease, liver/pancreas and bile ductdisorders, and red cell destruction
To diagnose and screen for diabetes and intermediate
hyperglycaemia, to diagnose hypoglycaemia

Dipstick
Dipstick

Urine
Urine

Dipstick
Glucometer

Capillary whole blood
Urine
Capillary whole blood

Diagnosis and monitoring of diabetes mellitus

Handheld and small analyser

Capillary whole blood

To assess metabolic acidosis, diabetic keto-acidosis, sepsis anddehydration
To determine blood compatibility for blood transfusions; Rh
typing for pregnant women
Pregnancy

Electro-analytical method
Handheld analyser
Antisera for agglutination

Arterial whole blood
Venous whole blood
Capillary whole blood
Venous whole blood
Urine

Detection of UTIs (dipstick) and identification of red and whiteblood cells, casts, squamous epithelial cells, bacteria, yeast,
Schistosoma haematobium and other cellular components(microscopy)
Microbial morphology, presence/absence of white blood cells
versus squamous epithelial cells for presumptive identification

Multi-parameter strips (dipstick)and light microscopy

Urine

Microscopic examination of slides
as wet preparations or whichhave been treated with a varietyof organism-specific chemical
stains (e.g. Gram stain)

Disease appropriate specimens (e.g.
venous whole blood, urine, stool, etc.)

GlucoseHaemoglobin A1c(HbA1c)Whole blood lactate
Blood transfusion

Blood typing

Serology

Human chorionicgonadotropin (hCG)
Urine dipstick andurine microscopy

Microbiology,
mycology andparasitology

Microscopy

Dipstick12

I.b Disease-specific IVDs for primary health care

Hepatitis B

Diagnostic test

Test purpose

Assay format

Specimen type

WHO prequalified or
endorsed products

WHO supporting documents

Hepatitis B
surface antigen(HBsAg)Screening for acuteand chronic
hepatitis B (HBV)
infection: infants
over 12 months ofage, children,
adolescents, adults
Staging to assess
the need for HBV
treatment inchronic HBV
infection
Screening for HCV
infection: infants
over 18 months ofage, children,
adolescents, adults
HIV self-testing

RDT

Oral fluid
Capillary whole blood

http://www.who.int/di
agnostics_laboratory/evaluations/pqlist/hbsag/public_report/en/Guidelines on hepatitis B and C testing (February2017):
http://apps.who.int/iris/bitstream/handle/10665/25
4621/9789241549981-eng.pdf?sequence=1

RDT

Capillary whole blood

N/A

RDT

Oral fluid
Capillary whole blood

RDT

Oral fluid
Capillary whole blood

http://www.who.int/di
agnostics_laboratory/evaluations/pqlist/hcv/public_report/en/
http://www.who.int/di
agnostics_laboratory/evaluations/pq-list/selftesting_publicreport/en/

For the diagnosis of
HIV infection:
adults, adolescents,
children and infants
over 18 months of
age

RDT

Oral fluid
Capillary whole blood

Hepatitis B eantigen (HBeAg)

Hepatitis C

Antibodies to
HCV(anti-HCV)HIV

Antibodies to HIV
1/2 (anti-HIV) test

Guidelines on hepatitis B and C testing (February2017):
http://apps.who.int/iris/bitstream/handle/10665/25
4621/9789241549981-eng.pdf?sequence=1
Guidelines on HIV self-testing and partner
notification (2016)
http://apps.who.int/iris/bitstream/handle/10665/25
1655/9789241549868-eng.pdf?sequence=1
Consolidated guidelines on HIV testing services (July
2015) http://www.who.int/hiv/pub/guidelines/hivtesting-services/en/
WHO implementation tool for pre-exposure
prophylaxis (PrEP) of HIV infection, module 10 for
testing providers (2017)
http://www.who.int/hiv/pub/prep/prepimplementation-tool/en/

13

I.b Disease-specific IVDs for primary health care
Diagnostic test

Test purpose

Assay format

Specimen type

WHO prequalified or
endorsed products

WHO supporting documents

HIV

Combined HIV
antibody/p24
antigen (antiHIV/p24 Ag) test

RDT

Oral fluid
Capillary whole blood

http://www.who.int/di
agnostics_laboratory/evaluations/pq-list/hivrdts/public_report/en/

Consolidated guidelines on HIV testing services (2015)
http://www.who.int/hiv/pub/guidelines/hiv-testingservices/en/

Malaria

Plasmodium spp.
antigens; species
specific (e.g. HRP2)
and/or pan-species
specific (e.g. panpLDH)

For the diagnosis of
HIV infection: adults,
adolescents, children
and infants over 18
months of age
For diagnosis of one
or more humanmalaria species (P.
falciparum, P. vivax, P.
malariae,
P. ovale)

RDT

Capillary whole blood

http://www.who.int/di
agnostics_laboratory/evaluations/pqlist/malaria/public_rep
ort/en/WHO guidelines for the treatment of malaria, third
edition (2015)
http://apps.who.int/iris/bitstream/10665/162441/1/9
789241549127_eng.pdf

Plasmodium spp.

For diagnosis of one
or more humanmalaria species(P. falciparum,
P. vivax, P. malariae,
P. ovale and P.
knowlesi) andmonitoring responseto treatment

Malaria rapid diagnostic test performance. Results of
WHO product testing of malaria RDTs: Round 7 (2015–2016)
http://www.who.int/malaria/publications/atoz/97892
4151268/en/

Light
microscopy(if good
quality
microscopy
available)

Capillary whole blood

N/A

WHO good practices for selecting and procuring rapid
diagnostic tests for malaria (2011)
http://apps.who.int/iris/bitstream/handle/10665/445
30/9789241501125_eng.pdf?sequence=1
WHO guidelines for the treatment of malaria, third
edition (2015)
http://apps.who.int/iris/bitstream/10665/162441/1/9
789241549127_eng.pdf
Basic malaria microscopy Part I: Learner’s guide (2010)
http://apps.who.int/iris/bitstream/handle/10665/442
08/9789241547826_eng.pdf?sequence=1
Malaria microscopy standard operating procedures(2015)
http://www.wpro.who.int/mvp/lab_quality/mm_sop/en/14

I.b Disease-specific IVDs for primary health care

Tuberculosis

Diagnostic test

Test purpose

Assay format

Specimen type

WHO prequalified or endorsed
products(all TB tests are evaluated andguidelines developed through the
WHO Global TB Programme)

WHO supporting documents

Mycobacterium
tuberculosis
bacteria

For the diagnosis
and treatment
monitoring of active
TB

Microscopy

Sputum

Implementing tuberculosis
diagnostics: Policy framework(2015)
http://apps.who.int/iris/bitstre
am/10665/162712/1/9789241
508612_eng.pdf

Compendium of WHO guidelines and associatedstandards: Ensuring optimum delivery of the cascade ofcare for patients with tuberculosis (2017)
http://apps.who.int/iris/bitstream/handle/10665/25918
0/9789241512572-eng.pdf?sequence=1

For the diagnosis ofactive TB

LAMP

SputumFor the diagnosis oflatent TB infection

Intradermalskin test (TST)N/A

The use of loop-mediatedisothermal amplification (TBLAMP) for the diagnosis of
pulmonary tuberculosis: Policy
guidance (2016)
http://apps.who.int/iris/bitstre
am/10665/249154/1/9789241
511186-eng.pdf?ua=1
Latent TB infection: Updated
and consolidated guidelines for
programmatic management(2018)
http://apps.who.int/iris/bitstre
am/handle/10665/260233/9789241550239eng.pdf;jsessionid=6D1BB2463
12B378ACFEBF9BFFAFEB0ED?s
equence=1

Immuneresponse

Implementing tuberculosis diagnostics: Policy
framework (2015)
http://apps.who.int/iris/bitstream/10665/162712/1/9789241508612_eng.pdf

15

I.b Disease-specific IVDs for primary health care

Syphilis

Diagnostic test

Test purpose

Assay format

Specimen type

WHO prequalified or endorsed
products

WHO supporting documents

Antibodies to
Treponema
pallidum

For the diagnosis oras an aid in the
diagnosis of T.
pallidum

RDT

Capillary wholeblood

http://www.who.int/diagnostic
s_laboratory/evaluations/PQ_li
st/en/

Combined
antibodies to T.
pallidum and to
HIV-1/2 (anti-HIV)

For diagnosis or as
an aid in the
diagnosis of HIV-1/2
and/or T. pallidum

RDT

Capillary wholeblood

http://www.who.int/diagnostic
s_laboratory/evaluations/pqlist/hiv-rdts/public_report/en/

WHO laboratory diagnosis of sexually transmitted
infections, including human immunodeficiency virus(2013)
http://apps.who.int/iris/bitstream/handle/10665/85
343/9789241505840_eng.pdf?sequence=1
WHO Information note on the use of dual
HIV/syphilis rapid diagnostic tests (RDT) (2017)
http://apps.who.int/iris/bitstream/handle/10665/25
2849/WHO-RHR-17.01-eng.pdf?sequence=1

16

II List of Essential In Vitro Diagnostics (EDL): For health care facilities with clinical laboratories
This list includes district, regional, provincial or specialized hospitals or laboratories and national reference laboratories.
Trained laboratory technicians, specialist expertise and laboratory infrastructure/equipment are available at the appropriate level.
Note: All diagnostic tests available at the primary care level are assumed to be available at higher levels as appropriate.
The list includes: section a for general laboratory equipment; and section b tests for specific diseases.
II.a General IVDs for health care facilities with clinical laboratories
Note: See list of WHO supporting documents at the end.

Clinicalchemistry andimmunoassays

Diagnostic test

Test purpose

Assay format

Specimen type

Alanine aminotransferase (ALT)

To assess liver function(often done with AST)

Optical and electro-analytical methods

Serum
PlasmaAlbumin

To detect/monitor malnutrition, liver or kidney disease

Photometric, turbidimetric andnephelometric testing

Alkaline phosphatase

To detect/monitor malnutrition, Paget's disease or certain
malignancies, including liver cancer
To assess of liver function(often done with ALT)To detect/monitor liver disease, liver/pancreas and bile ductdisorders, and red cell destruction
To assess lung function, metabolic or kidney disorders, andmonitor oxygen therapy
Measurement of blood pH, oxygen and carbon dioxide
To assess kidney function and disease

Colorimetric testing

Urine
Serum
PlasmaSerum
PlasmaSerum
PlasmaSerum
PlasmaArterial whole blood
Venous whole blood

To estimate glomerular filtration rate (eGFR) and urine
albumin/creatinine ratio
Key clinical marker for management of severe infections (i.e.
sepsis, Lassa fever), as well as antimicrobial regimen adjustment
To monitor organ damage and electrolyte alterations

Optical and electro-analytical methods

Aspartate aminotransaminase (AST)
Bilirubin
Blood pH and gases

Blood urea nitrogen(BUN)
CreatinineElectrolytes

Optical and electro-analytical methods
Optical and electro-analytical methods
Electro-analytical methods, including
portable analysers
Optical and electro-analytical methods

Optical and electro-analytical methods

Serum
Plasma
Serum
Urine

Serum
Plasma17

II.a General IVDs for health care facilities with clinical laboratories
Note: See list of WHO supporting documents at the end.

Clinicalchemistry andimmunoassays

Diagnostic test

Test purpose

Assay format

Specimen type

GlucoseTo diagnose and screen for diabetes and intermediate
hyperglycaemia, to diagnose hypoglycaemia
Diagnosis and monitoring of diabetes mellitus

Automated analyser

PlasmaSerum
Capillary whole blood
Venous whole blood

RDT
EIA

Basic metabolic panel(BMP)

To detect inflammation as an indicator of various conditions (e.g.
cardiovascular disease [CVD] – high sensitivity CRP required,
sepsis)To assess risk of developing CVD and type 2 diabetes by measuringcholesterol, triglycerides and lipoproteins
Includes glucose, sodium chloride, carbon dioxide, BUN,
BUN/creatinine ratio, eGFR and may include calcium

Comprehensive
metabolic panel

BMP plus magnesium, protein, albumin, globulin, alb/glob ratio,bilirubin (direct or total), alkaline phosphatase, ALT/AST,

Amylase and lipase

To assess acute pancreatitis

Troponin T/I

For the diagnosis of myocardial infarction

Urinalysis

Detection of substances in the urine associated with metabolic
disorders, renal dysfunction or UTIs

Blood cross-matchingTransfusiontransmitted infections

Haemoglobin A1c(HbA1c)C-reactive protein(CRP)
Lipid profile

Bloodtransfusion

Serology

Human chorionicgonadotropin (hCG)

ELISA
Automated analyser

Colourimetry
Spectrophotometry
Photometric and colourimetric testing, ionselective potentiometry(8-parameter automated clinical chemistry
analyser)As with BMP(14 or more parameter automated clinicalchemistry analyser)
Colourimetric and photometric analysers

Venous whole blood
Serum
PlasmaPlasmaSerum
Venous whole blood
Serum
PlasmaEnzyme immunoassay (handheld or large
automated instrument)
Automated chemical analyser

Venous whole blood
Serum
PlasmaSerum
Peritoneal fluid (Amylase)
Venous whole blood
PlasmaUrine

To determine blood compatibility for blood transfusions; Rh typing
for pregnant women

Antisera for agglutination

Venous whole blood

To screen for Chagas, HTLV in the blood supply etc. (see also EDL
sections on HIV, hepatitis C, hepatitis B, syphilis)

EIA (microplate)
Manual method

Serum
PlasmaCLIA/ECL (automated instrument)

Serum
PlasmaOptical method

Serum

Pregnancy

18

II.a General IVDs for health care facilities with clinical laboratories
Note: See list of WHO supporting documents at the end.

Microbiology,
mycology andparasitology

Diagnostic test

Test purpose

Assay format

Specimen type

Urine dipstick andurine microscopy

Detection of UTIs (dipstick) and identification of red and whiteblood cells, casts, squamous epithelial cells, bacteria, yeast,
Schistosoma haematobium and other cellular components(microscopy)
Microbial morphology, presence/absence of white blood cells
versus squamous epithelial cells for presumptive identification

Multi-parameter strips (dipstick) and lightmicroscopy

Urine

Microscopic examination of slides as wet
preparations or which have been treatedwith a variety of organism-specific chemical
stains (e.g. Gram stain)
Culture on growth media plates andincubator followed by recovery of isolates
and species identification (traditional manualtechniques or automated equipment)
Blood culture bottle and incubator followedby recovery of isolates and species
identification (traditional manual techniques
or automated equipment)
Antimicrobial susceptibility testing of isolates– may be done manually using disc diffusion
technique or using automated platforms
Microhaematocrit centrifuge

Disease appropriate
specimens (e.g. venous
whole blood, urine, stool,
CSF, etc.)
Disease appropriate
specimens (e.g. venous
whole blood, urine, stool,
CSF etc.)
Venous whole blood

Microscopy

Haematology

CultureInitial step in the process of bacterial species detection andidentification to support selection of appropriate antibiotic
treatment regimens

Blood culture

For the diagnosis of bacterial and fungal blood stream infections(sepsis)Antimicrobial
susceptibility testing

Final step in the process of selection of appropriate antibiotic
treatment regimens after species identification

Haematocrit (Ht)Diagnosis and monitoring of anaemia
Volume of red blood cells as a percentage of total blood volume
To detect/diagnose a bleeding disorder or excessive clotting
disorder (PT); monitor performance of anticoagulant medications(INR)

Prothrombin time
test and international
normalized ratio(PT/INR)
Platelet countComplete bloodcount (CBC)
Automated,differential

Diagnosis of thrombocytopenia
Marker to manage severe infections associated with bleeding andsepsis (i.e. VHF, meningococcemia) and certain haematologicaldisorders
Evaluation of patient’s overall health and to detect a wide range ofdisorders, including anaemia, infection and leukaemia

Microbial isolates

Handheld or automated coagulation analyser

Capillary or venous whole
blood
Citrate plasma

Haemocytometer
Haematology analyser

Capillary whole blood
Venous whole blood

Automated hematology analyser (WBC, RBC,
platelets, Hb and Ht) includes lymphocytes,
monocytes and granulocytes (for three-partdifferential)

Venous whole blood

19II.b Disease-specific IVDs for health care facilities with clinical laboratories

Hepatitis B

Diagnostic test

Test purpose

Assay format

Specimen type

WHO prequalified or endorsed
products

WHO supporting documents

Hepatitis B surface
antigen (HBsAg)

Screening for acute andchronic hepatitis B (HBV)
infection: infants over 12months of age, children,
adolescents, adults

RDT

Venous whole blood
PlasmaSerum
PlasmaSerum
PlasmaSerum
Serum
Plasmahttp://www.who.int/diagnostic
s_laboratory/evaluations/pqlist/hbsag/public_report/en/

Guidelines on hepatitis B and C testing(February 2017)
http://apps.who.int/iris/bitstream/handle/
10665/254621/9789241549981eng.pdf?sequence=1

EIA
CLIA

Virological(HBV DNA –quantitative)

Staging to assess theneed for HBV treatment
in chronic HBV infection
and monitoring of
response to treatment

NAT

Hepatitis B e antigen(HBeAg)Staging to assess theneed for HBV treatment
in chronic HBV infection

EIA

Serum
Plasma

N/A

CLIA

Serum
PlasmaN/A

IgM-specificantibodies tohepatitis B core
antigen (IgM antiHBc)

For the diagnosis of acute
HBV infection – used foroutbreak investigation

EIA (microplate)
Manual method

Serum
PlasmaN/A

CLIA/ECL(automatedinstrument)

Serum
PlasmaN/A

Antibodies tohepatitis B surface
antigen (anti-HBs)

Determining
effectiveness of HBV
immunization at patientand at a population level
Also used as a marker forrecovery from HBV
infection

EIA (microplate)
Manual method

Serum
PlasmaN/A

CLIA/ECL(automatedinstrument)

Serum
PlasmaN/A

20

II.b Disease-specific IVDs for health care facilities with clinical laboratories

Hepatitis C

Diagnostic test

Test purpose

Assay format

Specimen type

WHO prequalified or endorsed
products

WHO supporting documents

Antibodies to HCV(anti-HCV)

Screening for HCV
infection: infants over 18
months of age, children,
adolescents, adults

RDT

Venous whole blood
PlasmaSerum
Serum
PlasmaSerum
Plasmahttp://www.who.int/diagnostic
s_laboratory/evaluations/pqlist/hcv/public_report/en/

Guidelines on hepatitis B and C
testing (February 2017)
http://apps.who.int/iris/bitstream/handle/10665/254621/978924154998
1-eng.pdf?sequence=1

EIA (microplate)
Manual method
CLIA/ECL(automatedinstrument)
EIA (microplate)
Manual method
CLIA/ECL(automatedinstrument)

Antibodies to HCV(anti-HCV) and HCVcore antigen (HCVcAg)

Screening for HCV past or
present infection: infants
over 18 months of age,children, adolescents,
adultsSerum
PlasmaSerum
Plasma

HCV core antigen(HCV cAg)

For the diagnosis ofviraemic HCV infection

CLIA/ECL(automatedinstrument)

Serum
PlasmaHCV RNA (qualitativeor quantitative)

For the diagnosis ofviraemic HCV infection
and monitoring of
response to treatment as
a test of cure

NAT

Serum
Plasma21

II.b Disease-specific IVDs for health care facilities with clinical laboratories

HIV

Diagnostic test

Test purpose

Assay format

Specimen type

WHO prequalified or endorsed
products

WHO supporting documents

Antibodies to HIV-1/2(anti-HIV) test

For the diagnosis of HIV
infection: adults,
adolescents, children andinfants over 18 months of
age

RDT

Venous whole blood
PlasmaSerum

http://www.who.int/diagnostic
s_laboratory/evaluations/pqlist/self-testing_publicreport/en/

EIA (microplate)
Manual method
CLIA/ECL(automatedinstrument)

Serum
PlasmaSerum
PlasmaGuidelines on HIV self-testing and partner
notification (2016)
http://apps.who.int/iris/bitstream/handle/
10665/251655/9789241549868eng.pdf?sequence=1
Consolidated guidelines on HIV testing
services (July 2015)
http://www.who.int/hiv/pub/guidelines/hi
v-testing-services/en/

Combined HIV
antibody/p24 antigen(anti-HIV/p24 Ag) test

For screening for HIV inthe blood supply and inblood products

EIA (microplate)
Manual method
CLIA/ECL(automatedinstrument)

Serum
PlasmaSerum
PlasmaN/A

For the diagnosis of HIV
infection: adults,
adolescents, children andinfants over 18 months of
age

RDT

Venous whole blood
PlasmaSerum
Serum
PlasmaSerum
Plasmahttp://www.who.int/diagnostic
s_laboratory/evaluations/pqlist/hiv-rdts/public_report/en/

Serum
PlasmaSerum
PlasmaN/A

For screening for HIV inthe blood supply and inblood products

EIA (microplate)
Manual method
CLIA/ECL(automatedinstrument)
EIA (microplate)
Manual method
CLIA/ECL(automatedinstrument)

WHO implementation tool for preexposure prophylaxis (PrEP) of HIV
infection, module 10 for testing providers(2017)
http://www.who.int/hiv/pub/prep/prepimplementation-tool/en/
Screening donated blood for transfusiontransmissible infections: Recommendations(2009)
http://apps.who.int/iris/bitstream/handle/
10665/44202/9789241547888_eng.pdf?sequence=1&isAllowed=y
Consolidated guidelines on HIV testing
services (2015)
http://apps.who.int/iris/bitstream/handle/
10665/179870/9789241508926_eng.pdf?sequence=1

Screening donated blood for transfusiontransmissible infections: Recommendations(2009)http://apps.who.int/iris/bitstream/handle/10665/44202/9789241547888_eng.
pdf?sequence=1&isAllowed=y22

II.b Disease-specific IVDs for health care facilities with clinical laboratories

HIV

Diagnostic test

Test purpose

Assay format

Specimen type

WHO prequalified or endorsed
products

WHO supporting documents

HIV qualitative
virological or
quantitative
virological

For the diagnosis of HIV
infection in infants under
18 months of age

NAT

http://www.who.int/diagnostic
s_laboratory/evaluations/pqlist/hiv-vrl/public_report/en/

Consolidated guidelines on the use ofantiretroviral drugs for treating andpreventing HIV infection (2016)
http://www.who.int/hiv/pub/arv/arv2016/en/

HIV quantitative
virological

Monitoring of responseto antiviral treatment

NAT

CD4 cell enumeration(quantitative)

For staging of advanced
HIV disease

Flow cytometry

Capillary whole blood
Venous whole blood
Dried blood spot
Serum
PlasmaDried blood spot
Serum
PlasmaCapillary whole blood
Venous whole blood

Cryptococcal antigen
test

For screening anddiagnosis of cryptococcal
meningitis in people livingwith advanced HIV
diseaseRDT

CSF
Venous whole blood
Serum
PlasmaCSF
Serum
PlasmaN/A

EIA

http://www.who.int/diagnostic
s_laboratory/evaluations/pqlist/hiv-vrl/public_report/en/
http://www.who.int/diagnostic
s_laboratory/evaluations/pqlist/hiv-vrl/public_report/en/
Guidelines for the diagnosis, prevention,and management of cryptococcal disease
in HIV-infected adults, adolescents andchildren (2018)
http://apps.who.int/iris/bitstream/handle/
10665/260399/9789241550277eng.pdf?sequence=1

23

II.b Disease-specific IVDs for health care facilities with clinical laboratories

Malaria

Diagnostic test

Test purpose

Assay format

Specimen type

WHO prequalified or endorsed
products

WHO supporting documents

Plasmodium spp.
antigens; species
specific (e.g. HRP2)
and/or pan-species
specific (e.g. panpLDH)

For diagnosis of one ormore human malaria
species (P. falciparum, P.
vivax, P. malariae, P.
ovale)

RDT

Capillary whole blood
Venous whole blood

http://www.who.int/diagnostic
s_laboratory/evaluations/pqlist/malaria/public_report/en/

WHO guidelines for the treatment ofmalaria, third edition (2015)
http://apps.who.int/iris/bitstream/10665/
162441/1/9789241549127_eng.pdf
Malaria rapid diagnostic test performance:
Results of WHO product testing of malaria
RDTs: Round 7 (2015–2016)
http://www.who.int/malaria/publications/atoz/978924151268/en/
WHO good practices for selecting andprocuring rapid diagnostic tests for malaria(2011)
http://apps.who.int/iris/bitstream/handle/
10665/44530/9789241501125_eng.pdf?sequence=1

Plasmodium spp.

For diagnosis of one ormore human malaria
species (P. falciparum, P.
vivax, P. malariae, P.
ovale and P. knowlesi)and monitoring responseto treatment

Light microscopy

Capillary whole blood
Venous whole blood

N/A

WHO guidelines for the treatment ofmalaria, third edition (2015)
http://apps.who.int/iris/bitstream/10665/
162441/1/9789241549127_eng.pdf
Basic malaria microscopy Part I: Learner’s
guide (2010)
http://apps.who.int/iris/bitstream/handle/
10665/44208/9789241547826_eng.pdf?sequence=1
Malaria microscopy standard operatingprocedures (2015)
http://www.wpro.who.int/mvp/lab_quality/mm_sop/en/24II.b Disease-specific IVDs for health care facilities with clinical laboratories

Malaria

Diagnostic test

Test purpose

Assay format

Specimen type

WHO prequalified or endorsed
products

WHO supporting documents

Glucose-6-phosphate
dehydrogenase
activity (G6PD)

To determine G6PD
activity (normal,intermediate, deficient)and specifically to inform
decision to administer 8aminoquinoline groupdrugs for radical cure of
P. vivax
For screening newborns
for G6PD deficiency

Semi quantitative
fluorescent spot
test

Venous whole blood

http://www.who.int/diagnostic
s_laboratory/evaluations/pqlist/malaria/public_report/en/

Beutler E, Blume KG, Kaplan JC, Lohr GW,
Ramot B, Valentine WN. International
Committee for Standardization in
Haematology: Recommended screening
test for glucose-6-phosphate
dehydrogenase deficiency. Br J Haematol
1979;43:469–477
WHO guidelines for the treatment ofmalaria, third edition (2015)
http://apps.who.int/iris/bitstream/10665/
162441/1/9789241549127_eng.pdf

25

II.b Disease-specific IVDs for health care facilities with clinical laboratories

Tuberculosis

Diagnostic test

Test purpose

Assay format

Specimen type

WHO prequalified or endorsed products(all TB tests are evaluated and guidelines developed
through the WHO Global TB Programme)

WHO supporting documents

Mycobacterium
tuberculosis
bacteria

For the diagnosis
and treatment
monitoring of active
TB
For the diagnosis
and treatment
monitoring of active
TB including drugresistant TB
For the diagnosis ofactive TB andsimultaneous
detection ofrifampicin
resistanceMicroscopy

Otherspecimen types

Implementing tuberculosis diagnostics: Policy
framework (2015)
http://apps.who.int/iris/bitstream/10665/162712/1/9789241508612_eng.pdf

Bacterial
cultureSputum orother specimen
types

Compendium of WHO guidelines andassociated standards: Ensuring optimum
delivery of the cascade of care forpatients with tuberculosis (2017)
http://apps.who.int/iris/bitstream/handle/10665/259180/9789241512572eng.pdf?sequence=1

Cartridge-based
NAT

Sputum or
EPTB specimen
types

M. tuberculosisDNA

M. tuberculosis
DNA mutations
associated withresistanceFor the detection ofresistance for firstline anti-TB
medicines

Molecular LPA

SputumM. tuberculosis
DNA mutations
associated withresistanceFor the detection ofresistance forsecond-line anti-TB
medicines

Molecular LPA

Sputum

WHO Meeting report of a technical expert
consultation: Non-inferiority analysis of Xpert
MTB/RIF Ultra compared to Xpert MTB/RIF (2017)
http://apps.who.int/iris/bitstream/handle/10665/2
54792/WHO-HTM-TB-2017.04eng.pdf;jsessionid=E02D0994930EDBD9A4BC5BB3D
3A28568?sequence=1

Implementing tuberculosis diagnostics:
Policy framework (2015)
http://apps.who.int/iris/bitstream/10665/162712/1/9789241508612_eng.pdf

Automated real-time nucleic acid amplification
technology for rapid and simultaneous detection of
tuberculosis and rifampicin resistance: Policy
update (2013)
http://apps.who.int/iris/bitstream/10665/112472/1/9789241506335_eng.pdf
The use of molecular line probe assays for thedetection of resistance to isoniazid and rifampicin:
Policy update (2016)
http://apps.who.int/iris/bitstream/10665/250586/1/9789241511261-eng.pdf?ua=1
The use of molecular line probe assays for thedetection of resistance to second-line antituberculosis drugs: Policy update (2016)
http://apps.who.int/iris/bitstream/handle/10665/2
46131/9789241510561-eng.pdf?sequence=1

26

II.b Disease-specific IVDs for health care facilities with clinical laboratories

Tuberculosis

Diagnostic test

Test purpose

Assay format

Specimen type

WHO prequalified or endorsed products(all TB tests are evaluated and guidelines developed
through the WHO Global TB Programme)

M. tuberculosis
culture-based
DST

To detect resistanceto first-line and/or
second-line anti-TB
medicines

DST

Bacterial
culture of M.
tuberculosis

Lipoarabinomannan (LAM)
antigenTo aid in the
diagnosis of TB in
seriously ill HIVpositive inpatients

RDT

Urine

Immuneresponse

For the diagnosis oflatent TB infection

IGRA

Venous whole
blood

Technical report on critical concentrations for drug
susceptibility testing of medicines used in thetreatment of drug-resistant tuberculosis (2018)
http://www.who.int/tb/publications/2018/WHO_te
chnical_report_concentrations_TB_drug_susceptibil
ity/en/The use of lateral flow urine lipoarabinomannan
assay (LF-LAM) for the diagnosis and screening ofactive tuberculosis in people living with HIV: Policy
update (2015)
http://apps.who.int/iris/bitstream/handle/10665/1
93633/9789241509633_eng.pdf;jsessionid=9A9EB8
86DC17658BF7FDF86758D7A9F9?sequence=1
Latent TB Infection: Updated and consolidated
guidelines for programmatic management (2018)
http://apps.who.int/iris/bitstream/handle/10665/2
60233/9789241550239eng.pdf;jsessionid=6D1BB246312B378ACFEBF9BFFA
FEB0ED?sequence=1

WHO supporting documents27

II.b Disease-specific IVDs for health care facilities with clinical laboratories
Diagnostic test

Test purpose

Assay format

Specimen type

WHO prequalified or endorsed products

WHO supporting documents

HPV

Human
papillomavirus(HPV) DNAFor cervical cancer
screening

Nucleic acid test

Cervical cells
collected in test
specific transport
fluid

http://www.who.int/diagnostics_laboratory/
evaluations/pq-list/public_report_hpv/en/

Syphilis

Antibodies to
Treponema
pallidum

For diagnosis or as an
aid in the diagnosis of
T. pallidum

RDT

Venous whole blood
PlasmaSerum
Serum
PlasmaSerum
Plasmahttp://www.who.int/diagnostics_laboratory/
evaluations/PQ_list/en/

WHO human papillomavirus laboratory
manual, first edition (2009)http://apps.who.int/iris/bitstream/handl
e/10665/70505/WHO_IVB_10.12_eng.pd
f?sequence=1
WHO laboratory diagnosis of sexuallytransmitted infections, including humanimmunodeficiency virus (2013)
http://apps.who.int/iris/bitstream/handl
e/10665/85343/9789241505840_eng.pd
f?sequence=1

Serum
PlasmaN/A

Venous whole blood
PlasmaSerum

http://www.who.int/diagnostics_laboratory/
evaluations/pq-list/hivrdts/public_report/en/

For screening bloodand blood products

Combined
antibodies to T.
pallidum and to
HIV-1/2 (antiHIV)

For the diagnosis oras an aid in the
diagnosis of HIV-1/2
and/or T. pallidum

EIA (Microplate)
Manual method
CLIA/ECL(automatedinstrument)
EIA (Microplate)
Manual method

RDT

Screening donated blood for transfusiontransmissible infections (2009)http://apps.who.int/iris/bitstream/handl
e/10665/44202/9789241547888_eng.pd
f?sequence=1&isAllowed=y
WHO Information note on the use ofdual HIV/syphilis rapid diagnostic tests(RDT) (2017)
http://apps.who.int/iris/bitstream/handl
e/10665/252849/WHO-RHR-17.01eng.pdf?sequence=128

WHO supporting documents for general laboratory diagnostics
Asia Pacific strategy for strengthening health laboratory services (2010–2015); 2010 (http://www.wpro.who.int/health_technology/documents/asia_pacific_laboratory_strategy20102015.pdf?ua=1).
Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: Recommendations for a public health approach; 2016(http://apps.who.int/iris/bitstream/handle/10665/208825/9789241549684_eng.pdf?sequence=1).
Guidelines on hepatitis B and C testing; 2017 (http://apps.who.int/iris/bitstream/handle/10665/254621/9789241549981-eng.pdf?sequence=1).
HEARTS: Technical package for cardiovascular disease management in primary health care; 2018 (http://apps.who.int/iris/bitstream/handle/10665/260420/WHO-NMH-NVI-18.3eng.pdf;jsessionid=1FEE12C3923A2885107C0D9EEFBB82B0?sequence=1).
Interagency list of priority medical devices for essential interventions for reproductive, maternal, newborn and child health; 2015(http://www.who.int/medical_devices/publications/interagency_med_dev_list/en/).
Screening donated blood for transfusion-transmissible infections: Recommendations; 2009(http://apps.who.int/iris/bitstream/handle/10665/44202/9789241547888_eng.pdf?sequence=1&isAllowed=y).
Use of glycated haemoglobin (HbA1c) in the diagnosis of diabetes mellitus; 2011 (http://www.who.int/diabetes/publications/diagnosis_diabetes2011/en/).
WHO list of priority medical devices for cancer management; 2017 (http://www.who.int/medical_devices/publications/priority_med_dev_cancer_management/en/).
WHO Manual of basic techniques for a health laboratory, 2nd edition; 2003 (http://apps.who.int/iris/bitstream/handle/10665/42295/9241545305.pdf?sequence=1).
WHO publications on medical devices. Geneva: World Health Organization; 2018 (http://www.who.int/medical_devices/publications/en/).

29