Original Research

Delays in HIV-1 infant polymerase chain reaction testing may leave children without confirmed diagnoses in the Western Cape province, South Africa

Kamela L. Mahlakwane, Wolfgang Preiser, Nokwazi Nkosi, Nasheen Naidoo, Gert van Zyl
African Journal of Laboratory Medicine | Vol 11, No 1 | a1485 | DOI: https://doi.org/10.4102/ajlm.v11i1.1485 | © 2022 Kamela L. Mahlakwane, Wolfgang Preiser, Nokwazi Nkosi, Nasheen Naidoo, Gert van Zyl | This work is licensed under CC Attribution 4.0
Submitted: 04 December 2020 | Published: 23 June 2022

About the author(s)

Kamela L. Mahlakwane, Division of Medical Virology, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa; and, Division of Medical Virology, Tygerberg Hospital, National Health Laboratory Service, Cape Town, South Africa
Wolfgang Preiser, Division of Medical Virology, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa; and, Division of Medical Virology, Tygerberg Hospital, National Health Laboratory Service, Cape Town, South Africa
Nokwazi Nkosi, Division of Medical Virology, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa; and, Division of Medical Virology, Tygerberg Hospital, National Health Laboratory Service, Cape Town, South Africa
Nasheen Naidoo, Division of Clinical Pathology, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa; and, Division of Clinical Pathology, Tygerberg Hospital, National Health Laboratory Service, Cape Town, South Africa
Gert van Zyl, Division of Medical Virology, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa; and, Division of Medical Virology, Tygerberg Hospital, National Health Laboratory Service, Cape Town, South Africa


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Abstract

Background: Early diagnosis and confirmation of HIV infection in newborns is crucial for expedited initiation of antiretroviral therapy. Confirmatory testing must be done for all children with a reactive HIV PCR result. There is no comprehensive data on confirmatory testing and HIV PCR test request rejections at National Health Laboratory Service laboratories in South Africa.

Objective: This study assessed the metrics of routine infant HIV PCR testing at the Tygerberg Hospital Virology Laboratory, Cape Town, Western Cape, South Africa, including the proportion of rejected test requests, turn-around time (TAT), and rate of confirmatory testing.

Methods: We retrospectively reviewed laboratory-based data on all HIV PCR tests performed on children ≤ 24 months old (n = 43 346) and data on rejected HIV PCR requests (n = 1479) at the Tygerberg virology laboratory over two years (2017–2019). Data from sample collection to release of results were analysed to assess the TAT and follow-up patterns.

Results: The proportion of rejected HIV PCR requests was 3.3%; 83.9% of these were rejected for various pre-analytical reasons. Most of the test results (89.2%) met the required 96-h TAT. Of the reactive initial test results, 53.5% had a follow-up sample tested, of which 93.1% were positive. Of the initial indeterminate results, 74.7% were negative on follow-up testing.

Conclusion: A high proportion of HIV PCR requests were rejected for pre-analytical reasons. The high number of initial reactive tests without evidence of follow-up suggests that a shorter TAT is required to allow confirmatory testing before children are discharged.


Keywords

infant HIV PCR; confirmatory testing; early infant diagnosis; EID; laboratory diagnosis; antiretroviral therapy; turn-around time; follow-up testing

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