Userʼs Guide
Acceptance of samples from patients with speciﬁed infectious diseases

User s Guide

According to our regulations and the Infectious Diseases Control Law (Act on the Prevention of Infectious
Diseases and Medical Care for Patients with Infectious Diseases), we cannot accept samples from patientswith confirmed infectious diseases, suspected disease carriers, and asymptomatic carriers.
Please refer to the following diseases.
[Specified Infectious Diseases]· Class I Infectious Diseases
Ebola haemorrhagic fever, Crimean-Congo haemorrhagic fever, smallpox, South American hemorrhagicfever, plague, Marburg disease, Lassa fever’The storage period of the submitted sample
The samples are stored for 3 weeks from the request day, and covering requests for retests and additional
tests. However, the samples for a peripheral blood test and some other tests will be stored for 1 week. SRL
will dispose of the samples after the storage period is over. If a test is outsourced by SRL to an externalsite, the samples will be stored in compliance with the regulations of the site. Samples for new types ofinfectious diseases that have not yet been established may be disposed of without storage.

About use of specimens that have passed the storage period for the purpose of accuracy control, etc
After the storage period has elapsed, the samples may be processed to prevent identification of personal
information, and then used for the purpose of accuracy control, etc. On the other hand, in tests that
include measurement using a next-generation sequencer, the nucleotide sequence information obtained
may be used as a personal identification code. The tested samples and the nucleotide sequence information
themselves, which are stored with the personal identification code, cannot be irreversibly separated fromthe tested samples from the personal identification of the nucleotide sequence, or the personal identification
information from nucleotide sequence data cannot be removed from tested samples, when they are used forthe purpose of accuracy control, for example. Therefore, only in such cases, the nucleotide sequence data
can be used for accuracy control without removing the personal identifiers of the nucleotide sequence data.
However, we will strive to protect personal information by limiting the handling of nucleotide sequence
information and tested samples to those inspectors who have completed a training program for theprotection of personal information.

Statistic information
Please note the following points before requesting the test.
· We may prepare statistic information based on the information of specimen test consigned by you.
Statistic information is the information obtained collectively by each category after eliciting items
regarding common factors from information on several persons, and thus, cannot identify subjects oryou. The examples of such information are the number of consigned tests and positive rate per individual
test item by subjects’demographics such as specific region/time period, and age/ sex.
· The prepared statistic information will be used for our verification of test precision, referred in the fieldof public health epidemiology, reported on our homepage etc., and utilized for development/provision of
products/service of ours or a third party.

Points to note before requesting test items for RIA
Please note that remaining isotope administered tovalues in RIA.

in scintigraphy, etc. may result in abnormal

Disclaimer
Tests are conducted according to SRL criteria; however, depending on the condition of the sample wereceive, technical limitations of the test methods, etc., the results may not be suitable to determine clinicaldiagnosis. In this case, SRL will not be responsible for the test results.

RetestRetests are conducted according to SRL criteria.
If the sample you submitted does not satisfy the required test volume, retests cannot be conducted.

2 Userʼs Guide

Userʼs Guide
Contents for General Test Information
1. Specimen requirement： the sample volume is set considering the volume for the retest.

LdLmLμLfL
kggmg
μgngpgUmUμU
IUmIUAUliterdeciliter (＝0.1 L)milliliter (＝0.001 L)
microliter (＝10－6 L)
femtoliter (＝10－15 L)
kilogramgram
milligram (＝0.001 g)
microgram (＝10－6 g)nanogram (＝10－9 g)
picogram (＝10－12 g)
unit
milliunit (0.001 U)
microunit (10－6 U)
international unit
milliinternational unit (＝0.001 IU)
arbitrary unit

M
mmol
μmol
nmol
pmol
fmol
mmmm2
mm3
μ3
Meq
mEq
mOsm%
‰cpm
UAmol/L
millimole (＝0.001 mol)
micromole (＝10－6 mol)nanomole (＝10－9 mol)picomole (＝10－12 mol)femtomole (＝10－15 mol)millimetersquaremillimetercubicmillimetercubicmicron
megaequivalents
milliequivalentmilliosmole
percent
permillcounts per minutes
unit allergen

Userʼs Guide

3’Major units and symbols

User s Guide

Please collect serum or plasma sample of about 3 times more than the required
volume. (Please see page ① for blood sampling method)
2. Storage： Please submit samples stored in the specified manner.
F Submit the sample under frozen conditions (≤ -10°C).
R Submit the sample under refrigeration (2°C–15°C).
R Submit the sample at room temperature (16°C–30°C).
3. Reference range：“Normal reference values and criteria”is described as REFERENCE RANGE for SRL.
“REFERENCE RANGE”includes reference range and clinical judgement range.
4. Turnaround time (day)： The period is, in principle, from the day after we received the sample to theday the results are delivered to you (including Saturdays and Sundays).
Please be aware that there may be delays in receiving results for the following
circumstances.
・In the event of a retest or when submitted just before/after a nationalholiday
・In the event materials in the order do not match the description・In the event an order is placed at the same time as a test item with the freeze
symbol・In the event an order that, due to unavoidable circumstances, has been placedat the same time as one with the no overlapping requests symbol.
5. Sample collection conditions： The following are some points to note when collecting samples
appropriately. (See COMMENT or container handling method. )6. Conditions for submission： Items such as whether serum separation is required or not are essential
for appropriate test/measurement. (See COMMENT or container handling
method.)Immediately After blood sample collection, avoid long-time storage at room temperature and centrifuge it
immediately. Some items have designated time to centrifuge, while others require cooling prior topretreatment or centrifuge. See COMMENT or container handling method as well.
Refrigerated Please centrifuge the samples at low temperature (4°C).
7. Test value range for emergency report Emergency ： The test value range for emergency report (Seepage 1) is set. If a value exceeds the range, we willcontact you immediately.
8. Reserved test Reservation ： An advanced reservation is required for the test. Please contact your nearest
oﬃce prior to taking the sample.
9. The speciﬁed days of the week Speciﬁed days ： Make sure that the day of the week (except holidays) is
specified to receive the sample. See COMMENT in the text
for acceptable days.

Userʼs Guide
List of markers

User s Guide

Notifications/
reportReserved test

Reservation

An advanced reservation is required for the test.
Please contact the oﬃce nearest you prior to taking the sample.

Specifieddays of theweek

Speciﬁed days

Make sure that the day of the week (except holidays) is specified toreceive the sample.
See COMMENT in the text for acceptable days.

Emergency

Emergency

The test value range for emergency report (See page 1) is set.
If a value exceeds the range, we will contact you immediately.

Human ethics

EthicsSubject to ethical guidelines for human genes.
Please contact the person in charge in advance.

PGx

PGx

Subject to pharmacogenomics (PGx).
Please contact the person in charge in advance.

’Overseas

Sample handling
methodEffect on values

recommission

The samples are delivered overseas. The final test is conducted in theUS. Please note that the samples you provide will not be returned.

No overlapping overlap
requests

Avoid putting in another request at the same time.
Please note that the number of days required may vary if there is anunavoidable duplication of requests with other items.

Centrifuge
immediately

Immediately

After blood (urine) sample collection, avoid long-time storage at room
temperature and centrifuge it immediately. Some items have a designatedtime to centrifuge, while others require cooling prior to pretreatment orcentrifuge. See COMMENT or dedicated container handling method as well.

Refrigerated
centrifuge

Refrigerated

Please centrifuge the samples at low temperature (4°C).

FreezeF

Submit the sample under frozen conditions (≤ -10°C).

Refrigeration

R

Submit the sample under refrigeration (2°C–15°C).
Please freeze the sample for long-term storage, except for items
marked with Freeze .

RoomtemperatureR

Submit the sample at room temperature (16°C–30°C).

Light
shieldingLight Shielding

Avoid direct sunlight or fluorescent lamp light and submit samples witha light-shielding container.

No hemolysis

Hemolysis

Avoid hemolytic samples that may affect test values.

Noinactivation

Inactivation

Avoid inactivated samples that may affect test values.

No acid urine
collectionAcid Urine

Avoid acid urine collection that may affect test values.

No freezing

FreezeAvoid freezing at ≤ -10°C that may affect test values.

4 Userʼs Guide

Userʼs Guide
How to read the test name column

biochemical test

proteins, serum colloid reaction/enzymes and related materials

Points to note before requesting tests.

CODE

biochemical test

CodeWhenrequestingitems in the“Margin”
column of
the request
form, fill out
all alphabets
and numbers.

TEST NAME

0381 25203 9

SPECIMENREQUIREMENT(mL)

serum 0.5

Protein, total (TP)0246 3

CSF 0.5

CONTAINER

S09(1 month)

A00

R

Albumin (Alb)0721 4Albumin, Urine

5106 7

Albumin, Urine(creatinine ratio)

randomurine 10382 0A/G ratio

serum 0.56510 5

Proteinfractionation

serum 0.32265 1Urine protein
fractionation

randomurine 1U00
S09


A00

S09

RR
(21 days)

R(1 month)R(1 month)R(1 month)

RU00

RA00

METHODOLOGY REFERENCE RANGE (UNIT)
Biuretmethod

RA00

urine
collected
U00
for 24hrs. 0.5
S09
serum 0.5 A00
urine
collected
U00
for 24hrs. 0.55059 2

STORE
TURNAROUNDTEMPERATURE
TIME (DAY)(STABILITY)

2–4

6.7–8.3(g/dL)

15–45

Pyrogallol
red method

COMMENT’

Test nameproteins, serum colloid reaction

検査案内統合版 2015 統合版 改作／ D4 校
データ作成日：15/06/01

Methodology names are shown. Please see pages
A–E for overview of methodology.

(mg/dL)

31.2–120.0(mg/day)

Improved 3.8–5.2
2–4 BCPmethod
Turbidimetric 2–20
2–4 immunoassay(TIA)

Reaction method with BCP,
highly specific to human(g/dL) albumin.

(mg/day) Acid Urine

Urinary albumin

Turbidimetric ratio
Acid Urine
2–4 immunoassay ≤ 10.0
(TIA)
(mg/g CRE)
Improved
BCP
2–4 method/ 1.1–2.1
Biuretmethod
ALB
55.8–66.1 (%)α1-globulin(%)
2.9–4.9α2-globulin
7.1–11.8 (%)β1-globulin
Capillary(%)
electrophoresis 4.7–7.2
β2-globulin
2–4(%)
3.2–6.5γ-globulin
11.1–18.8 (%)
A/G
1.3–1.9Hemolysis

Avoid hemolytic samples.

Make sure to order Code No.

Agarose gelelectrophoresis(%) 6510 5: Protein fractionation
for serum specimens.

A modified standard
method by theSociety of 4.0–12.0
2–4 Japanese
Gastroenterology’sWorking Group on
Liver Function

Zinc sulfate
S09
RserumPlease
0.5 0385 1 conditions
turbidity test
The following are the storage
for submission.
A00 (3 days)(ZTT,Kunkel)
note that these are not storage conditions after blood collection.
The stability in parentheses presents a rough indication of time
S09 See below. JSCC
CreatineRpossible for sample storageon ourkinase
data.
serum 0.5 
2–4 reference
0433 3 based(CPK)methodA00 (10 days)(U)

enzymes and related materials

Male: 62–287
Female: 45–163(U/L)
MB: ≤specific25
Refer to the following examples for handling containers. SomeImmunologicalitems haveconditions
for handlingThis
test will be reported
inhibitionTOTAL
along with the results
R
Ultraviolet
containers. See COMMENTor container handling method
aswell.
M 62-287
0789 5absorptionoftheTOTALCK(CPK)
S09 (6 days)
F 45-163
serumCK-MBmeasurement.
2–4 spectrophotometry
(U/L)
(UV)
0.5 each(CPK-MB)(Ex.1) serum samples

5629 8A00FCLIA≤ 5.0SPECIMEN
Collect blood samples in the container for general(ng/mL)
purpose use (S09).
REQUIREMENT CONTAINER After centrifuge, pipet 0.5 mL of serum intoBB:≤ 2(A00) container and submit it.
theImmediately S09(mL)
MB: ≤ 6
Separate serum immediately
kinaseAgarose gelF
2–4 or0198 1 Creatine
Please collect 3 times moreserum
plasmasamplethanvolume.
afterthebloodrequiredis drawn.
MM:93–99
electrophoresis
S09 (CPK) isoenzymes serum 0.3 A00(%)
serum 0.5➡
A00

(Ex.2) when transferring a sample into a container with additives and submitting the supernatant after centrifuge
SPECIMEN
Collect blood samples in the container designated by SRL (PN2, PN5).
REQUIREMENT CONTAINER After centrifuge, pipet 0.5 mL of plasma into the (A00) container and submit it.
(mL)
Please collect 3 times more serum or plasma sample than the required volume.
PN2, PN5
plasma 0.5➡
A00(Ex. 3) blood sample with additives
SPECIMEN
Pipet 5.0 mL of blood into the container designated by SRL (PN7). Mix it well and submit it.
proteins,Useserum
colloidreaction/enzymes
and relatedmaterials
1 CONTAINERREQUIREMENT
the samecontainer(PN7) for collectionand submission.
(mL)
Do not transfer into a different container.
whole blood
5.0(with EDTA-2Na)

PN7

Userʼs Guide

User s Guide

The period is from the day after we receive the sample to the day the results are delivered to you.
Additional days are necessary for retests or before and after holidays.

5