Nnaca Sop 302

NPS/LP-302
STANDARD OPERATING PROCEDURE for

Nigeria PreP Study
Study Site: SOPs Number : LP-302
Title
SPECIMEN RECEIPT AND HANDLING PROCEDURES
Version Number: Version Date: Effective date:
Approval name Signature Date
Annual Review
Review date Revision Date Signature
Document History
Version number Reason for change Date

1.0 Initial release 28th March 2015
Distribution List
Name/Location No of copies Name/Location No of copies
1. Introduction
All data must be recorded on laboratory request forms and samples assessed for quality and
adequate volume for testing. If critical data is missing or a test cannot be performed because
of insufficient quantity or unacceptable quality, additional information or samples must be
obtained to assure all tests are performed. Samples must be stored according to guidelines
prior to analysis to preserve sample integrity and afterwards should additional or repeat
testing be required. Non-archived samples must be treated as infectious waste and autoclaved
prior to discarding.
NPS/LP-302
2. Objectives
This standard operating procedure (SOP) describes the steps for the receipt of blood samples
for study, assessing acceptability, rejection criteria, pre and post analysis storage and
distribution of samples to other laboratories for testing or archiving (freezing).
3. Scope
This SOP applies to the receipt and handling of specimens for all laboratory personnel who
have been trained and are competent in the receipt, handling and distribution of specimens for
laboratory tests.
4. Responsibility
All laboratory personnel who have been trained and are competent in the receipt, handling
and distribution of specimens for laboratory tests.
5. Standard precautions
Wear gloves when handling participant specimens to protect from exposure to blood borne
pathogens.
6. Specimen receipt procedures

Study laboratory staff are responsible for receiving, storing and redirecting specimens when
appropriate.
a. Check laboratory request form for the following information:
i. Visit Date
ii. Participant’s Gender
iii. Screening ID #
iv. Participant ID #
v. Date and time of specimen collection
vi. Initials and date of specimen collector
vii. Confirm collection column checked and initialled
b. If any data is missing, complete a DATA/SPECIMEN CLARIFICATION request

form and return to Site Coordinator. Process specimens that have study numbers so
as not to compromise specimen integrity.
NPS/LP-302
c. Inspect all tubes/bottles for proper labelling with Study ID and Collection date
(minimal) and initials of collector. Unlabeled specimens are not acceptable for testing.
Complete a DATA/SPECIMEN CLARIFICATION to request properly labelled
specimens and return form to Site Coordinator.
d. Check off all specimens received in the “Confirm Receipt” column and enter initials
in the space provided.
e. Determine if sufficient specimen of acceptable quality is available for all tests (see
minimal volumes and rejection criteria in Table 1.).
f. Complete a DATA/SPECIMEN CLARIFICATION form if quantity or quality of
specimen is inadequate. Describe tests that cannot be performed and request
additional sample. Submit form to Site Coordinator.
g. Keep all laboratory test request forms for 10 years in a secure, fire-protected space.
7. Distribution of samples to other laboratories for testing

 Consult Table 2. for sample destinations.
 Make a copy of the request form to be sent with specimen.
 Check that there is adequate sample for testing.
 Place sample in Biohazard specimen bag and seal.
 Take samples to the appropriate laboratory.
 Obtain signature of person receiving the specimen on the original specimen request
form.
7. Specimen storage/archiving
 Consult Table 2. for specimen storage and handling instructions pre and post analysis.
 Specimens held for testing in the laboratory or awaiting aliquoting/archiving should
be placed in labelled racks at the appropriate temperatures.
 Refer to Table 3 that lists tests for which aliquots are required for testing or archiving,
and archiving and labelling instructions.
 Each site should use their Laboratory Data Management System for organizing
freezer placement and labelling samples. This is to ensure that sites storage style are
not disorganised.
 Records of sample locations will be retained in log book format.
8. Specimen disposal
NPS/LP-302
 Specimens should be retained for the appropriate length of time post analysis. Refer to
Table 2 for retention times.
 Discard specimens regularly into an biohazard waste bag.
 Autoclave bag for 15 minutes at 121o C.
 Place bag in waste disposal area for incineration.
 Record Specimen Collection dates.
 Enter the initials of the staff that made the request and date.
Table 1. MINIMAL VOLUMES/SPECIMEN REJECTION CRITERIA

Test Specimen Minimal volume Rejection criteria
required for
testing
All tests All tests NA  Mislabelled (Participant and
Screening ID #s on specimen blood
and request form do not match.
 Unlabelled (No participant
information on specimen)
 Specimen collected in incorrect
tube type.
 Insufficient quantity for testing.
HIV test Blood 1ml  <1ml
CD4 count EDTA Blood 1ml  < 5ml
 Clotted
 Haemolysed
 >24 hrs post collection
HIV RNA EDTA Blood 1ml plasma  <5 ml blood,
Quantitation  Clotted
 Haemolysed
Creatinine Clotted Blood 2ml serum  <5ml blood
Hepatitis B Serum/plasma 3ml  <5ml blood
surface
antigen
NPS/LP-302
Table 2. SAMPLE DESTINATIONS & HANDLING INSTRUCTIONS
TEST TUBE LAB SPECIMEN SPECIMEN HANDLING/STORAGE PRE-ANALYSIS SPECIMEN

DESTINATION HANDLING/ HANDLING/STORAGE
TESTING POST-ANALYSIS
INSTRUCTIONS
HIV test EDTA Haematology Sent for Rapid Store whole blood at 2-8 o C up to 3 days. If testing delayed Store plasma at 2-8 o C up to
double ELISA >3 days, centrifuge and remove plasma. Store plasma at 2-8 3 days; >3 days freeze
o C up to 3 days; >3 days freeze plasma at -20o C. plasma at -20o C..
CD4 count EDTA Blood Haematology Done on HIV Pos Store at RT up to 24 hrs post collection. Test must be Test must be performed
patients only. performed within that time period. within 24 hrs. Specimen not
suitable >24 hrs post
collection.
HIV Viral EDTA Blood Haematology Done on HIV Pos Centrifuge blood at 3500 rpm/1500xg for 10 min, remove Store remaining plasma
Quantitation patients only. plasma and store 2 aliquots of 500 ul each at -80 o C. aliquots at -80 o C
Creatinine Clotted Blood Chemistry Clotted sample only Serum or plasma (creatinine in serum is stable for 24 hours Archive serum into 2ml
at 2–8ºC) cryovials at -80 o C.
Hepatitis B Serum/plasma Chemistry Clotted sample only Centrifuge at 3500 rpm/1500xg for 10 min, remove serum, Archive serum into 2ml
surface antigen freeze/archive serum into 2ml cryovials at -80 o C. cryovials at -80 o C.
NPS/LP-302
This SOP has been read and understood by:
Name Date Name Date

1. 8.
2. 9.
3. 10.
4. 11.
5. 12.
6. 13.
7. 14.

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NPS/LP-302

STANDARD OPERATING PROCEDURE for

Approval name Signature Date

Review date Revision Date Signature

Version number Reason for change Date

Name/Location No of copies Name/Location No of copies

6. Specimen receipt procedures

b. If any data is missing, complete a DATA/SPECIMEN CLARIFICATION request

7. Distribution of samples to other laboratories for testing

Table 1. MINIMAL VOLUMES/SPECIMEN REJECTION CRITERIA

Table 2. SAMPLE DESTINATIONS & HANDLING INSTRUCTIONS

TEST TUBE LAB SPECIMEN SPECIMEN HANDLING/STORAGE PRE-ANALYSIS SPECIMEN

This SOP has been read and understood by:

Name Date Name Date

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