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

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...

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Main Authors: Kamela L. Mahlakwane, Wolfgang Preiser, Nokwazi Nkosi, Nasheen Naidoo, Gert van Zyl
Format: Article
Language:English
Published: AOSIS 2022-06-01
Series:African Journal of Laboratory Medicine
Subjects:
Online Access:https://ajlmonline.org/index.php/ajlm/article/view/1485
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author Kamela L. Mahlakwane
Wolfgang Preiser
Nokwazi Nkosi
Nasheen Naidoo
Gert van Zyl
author_facet Kamela L. Mahlakwane
Wolfgang Preiser
Nokwazi Nkosi
Nasheen Naidoo
Gert van Zyl
author_sort Kamela L. Mahlakwane
collection DOAJ
description 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.
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spelling doaj.art-f28f227ea5e841d8aad2a30d34b43d3e2022-12-22T00:34:26ZengAOSISAfrican Journal of Laboratory Medicine2225-20022225-20102022-06-01111e1e710.4102/ajlm.v11i1.1485374Delays in HIV-1 infant polymerase chain reaction testing may leave children without confirmed diagnoses in the Western Cape province, South AfricaKamela L. Mahlakwane0Wolfgang Preiser1Nokwazi Nkosi2Nasheen Naidoo3Gert van Zyl4Division 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 TownDivision 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 TownDivision 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 TownDivision 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 TownDivision 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 TownBackground: 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.https://ajlmonline.org/index.php/ajlm/article/view/1485infant hiv pcrconfirmatory testingearly infant diagnosiseidlaboratory diagnosisantiretroviral therapyturn-around timefollow-up testing
spellingShingle Kamela L. Mahlakwane
Wolfgang Preiser
Nokwazi Nkosi
Nasheen Naidoo
Gert van Zyl
Delays in HIV-1 infant polymerase chain reaction testing may leave children without confirmed diagnoses in the Western Cape province, South Africa
African Journal of Laboratory Medicine
infant hiv pcr
confirmatory testing
early infant diagnosis
eid
laboratory diagnosis
antiretroviral therapy
turn-around time
follow-up testing
title Delays in HIV-1 infant polymerase chain reaction testing may leave children without confirmed diagnoses in the Western Cape province, South Africa
title_full Delays in HIV-1 infant polymerase chain reaction testing may leave children without confirmed diagnoses in the Western Cape province, South Africa
title_fullStr Delays in HIV-1 infant polymerase chain reaction testing may leave children without confirmed diagnoses in the Western Cape province, South Africa
title_full_unstemmed Delays in HIV-1 infant polymerase chain reaction testing may leave children without confirmed diagnoses in the Western Cape province, South Africa
title_short Delays in HIV-1 infant polymerase chain reaction testing may leave children without confirmed diagnoses in the Western Cape province, South Africa
title_sort delays in hiv 1 infant polymerase chain reaction testing may leave children without confirmed diagnoses in the western cape province south africa
topic infant hiv pcr
confirmatory testing
early infant diagnosis
eid
laboratory diagnosis
antiretroviral therapy
turn-around time
follow-up testing
url https://ajlmonline.org/index.php/ajlm/article/view/1485
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