Ministry of Health
Akala Health Centre Laboratory
Title: Handling HIV Inconclusive Result
Dickens otieno Document Number Effective Date
Author(s), Name & Sign: AHCL/SOP/0013 1ST MAY 2019
Title
Quality officer
Reviewed and Laboratory In charge Signature Date
Approved By
Geoffrey Chelimo
SOP Annual Review Name, Title Signature Date
Next Review Date: 1ST MAYs 2020
Revision Date Description (notes)
Version # [1.0]
[dd/mm/yy]
Revision
History
Distributed Name (or location) Copy # Name (or location) Copy #
Copies to
Page 1 of 6
Ministry of Health
Akala Health Centre Laboratory
Title: Handling HIV Inconclusive Result
1.0 Purpose:
To streamline procedures followed in the event that 1st rapid screening HIV test
(determine TM ) gives Positive results and 2nd confirmatory test (First Response
TM ) gives a negative result at both PITC and PSC/CCC, guidance in
management of HIV inconclusive results that HTS provider should follow in case
of inconclusive result during testing.
2.0 Principle:
2.1 DNA-PCR assay is a qualitative molecular based technique used for detection of
HIV viral nucleic acid in specimen. Application of correct specimen collection
technique, separation of plasma, storage and retrieval, packaging and shipment
assures of quality specimen for analysis and hence reliable results for
management of patients.
2.2 If a molecular based tests e.g. PCR, Long ELISA method are performed on a
samples from cases with discrepant test outcome, the method has the ability to
detect HIV antigens from the specimen during the early stages of infection,
thereby highly minimising chances of false positive result.
3.0 Materials/Requirements,
3.1.1 Inconclusive result tracking register
3.1.2 MOH 362
3.1.3 DBS filter paper
3.1.4 Dry cotton wool
3.1.5 Alcohol swab
3.1.6 EDTA capillary tubes.
3.1.7 Desiccants.
3.1.8 Drying rack.
3.1.9 Gauze or cotton wool.
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Ministry of Health
Akala Health Centre Laboratory
Title: Handling HIV Inconclusive Result
3.1.10 Glycine envelopes.
3.1.11 HIV diagnosis (DNA-PCR) laboratory Inconclusive requisition form.
3.1.12 Humidity indicator cards.
3.1.13 Sterile blood Lancet.
3.1.14 Powder free gloves.
3.1.15 Zip-lock bags.
4.0 Procedure.
4.1.1 The HTS provider/primary tester escorts the client to the CCC/PSC for retest to
confirm the PITC test results.
4.1.2 The second tester sets climate for retest and the organises the testing area
4.1.3 The second tester performs full cycle of HIV testing (retest) as recommended by
the HIV testing 2016 national algorithm.
4.1.4 For screening test follow the SOP for testing with DetermineTM Rapid testing kit
4.1.5 When test with DetermineTM turns positive/react, confirm with First ResponseTM
confirmation kit following FR SOP.
4.1.6 If FR turns positive enroll into care.
4.1.7 NB: incase a client was referred to CCC/PAC as positive client for retest and the
screening test (Determine) turns negative report as inconclusive and rebook the
client for another retest after two weeks.
4.1.8 On return after two weeks, and retest with the Determine turns negative report
inconclusive and collect a DBS.
4.1.9 If the FR turns Negative report as inconclusive result and collect DBS sample as
per the DBS SOP and explain the next test procedure to be performed to verify the
accuracy of the result.
4.1.10 Conduct a post counselling session to the client as per the Counselling and Linkage
SOP.
4.1.11 Inform the client of the preceding test procedure
4.1.12 Collect clients contacts information preferably cell phone number and physical
address for tracing.
4.1.13 Take the DBS to the laboratory for quality checks/verification and packaging in
Zip lock bag.
4.1.14 The laboratory repackage the DBS and relevant documentation including
adequately completed request form in an A4 brown envelope and addressed to the
National HIV Reference Laboratory (NHRL) Nairobi.P.0 BOX 20750
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Ministry of Health
Akala Health Centre Laboratory
Title: Handling HIV Inconclusive Result
Kenyatta National hospital Grounds Reference laboratory via Group 4 Securicor
(G4S) using NHRL account number ----------------.
5.0 Confirmation with the NHRL LAB in Nairobi
5.1.1 Expect confirmation from a call from NHRL lab a day after submitting the parcel
with the sample conforming the receipt at the PCR testing Laboratory (NHRL) at
NPHLS Nairobi.
5.1.2 If no call received a day after sample submission to the courier make a follow up
call using the telephone number in the inconclusive result request form with the
patient details to confirm receipt of the sample at the NHRL.
5.1.3 If the sample is not received as expected follow-up with the courier service
provider using weigh bill number for the sample referred to find cause of delay and
document as appropriate.
5.1.4 At the end of the 6th day after sending/referring the sample, check the result on the
lab email account or the email account provided in the request form.
5.1.5 If the result is in the mail download and print in duplicate for the laboratory
inconclusive result file and HTS Inconclusive result file, only produce third copy
on the patient request.
5.1.6 Irrespective of the outcome of the result HTS Incharge will arrange to contact the
client to come to receive the result.
5.1.7 On arrival of the client who had inclusive result, the HTS incharge assigns an HTS
provider to offer posttest counselling to the client as per the results release
guideline and counselling procedures.
5.1.8 If positive link the client to care for enrollment at the PSC/CCC.
5.1.9 If negative, discuss with the client about the risk, importance of reduction
measures and how to live negatively.
5.1.10 Update the MOH 362 register with the result from NHRL as the final test result for
the client.
6.0 Quality control
6.1.1 Proper collection and packaging of the DBS sample
6.1.2 Packing of completely dried DBS.
6.1.3 Properly dried DBS is chocolate brown in colour.
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Ministry of Health
Akala Health Centre Laboratory
Title: Handling HIV Inconclusive Result
7.0 Safety:
7.1.1 Wear personal protective equipment.
7.1.2 Handle all samples as potential biohazards.
7.1.3 Avoid touching the circles with your finger (even when on gloves) or anything
else.
8.0 Related procedures:
8.1.1 DetermineTM test procedure
8.1.2 First responseTM test procedure
8.1.3 HTS counselling and linkage Sop.
9.0 References.
9.1.1 Early infant diagnosis of HIV, standard operating procedure for DBS collection
for DNA-PCR testing, MOPHS/MOMS work-aid.
9.1.2 National public health laboratory services, strengthening laboratory services in
support of ART management (March, 2007), Laboratory standard operating
procedures, MOH publication, 1st edition
Training Log
By signing this log is an acknowledgement that I have read and understood the attached document.
DATE NAME SIGNATURE
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Ministry of Health
Akala Health Centre Laboratory
Title: Handling HIV Inconclusive Result
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