PIMA<sup>TM</sup> point-of-care testing for CD4 counts in predicting antiretroviral initiation in HIV-infected individuals in KwaZulu-Natal, Durban, South Africa
Introduction: Limited information is available on the usefulness of the PIMATM analyser in predicting antiretroviral treatment eligibility and outcome in a primary healthcare clinic setting in disadvantaged communities in KwaZulu-Natal, South Africa. Materials and methods: The study was conducted u...
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doaj-edf88d5f64894995b76c3be5be3e83222020-11-24T21:58:53ZengAOSISSouthern African Journal of HIV Medicine1608-96932078-67512016-06-01171e1e810.4102/sajhivmed.v17i1.444532PIMA<sup>TM</sup> point-of-care testing for CD4 counts in predicting antiretroviral initiation in HIV-infected individuals in KwaZulu-Natal, Durban, South AfricaMandisa Skhosana0Shabashini Reddy1Tarylee Reddy2Siphelele Ntoyanto3Elizabeth Spooner4Gita Ramjee5Noluthando Ngomane6Anna Coutsoudis7Photini Kiepiela8Department of Paediatrics and Child Health, University of KwaZulu-Natal, South Africa; Medical Research Council of South Africa, HIV Prevention Research Unit, South AfricaMedical Research Council of South Africa, HIV Prevention Research UnitMedical Research Council of South Africa, Biostatistics UnitMedical Research Council of South Africa, HIV Prevention Research UnitDepartment of Paediatrics and Child Health, University of KwaZulu-Natal, South Africa; Medical Research Council of South Africa, HIV Prevention Research Unit, South AfricaMedical Research Council of South Africa, HIV Prevention Research UniteThekwini Health Unit, eThekwini MunicipalityDepartment of Paediatrics and Child Health, University of KwaZulu-NatalMedical Research Council of South Africa, HIV Prevention Research UnitIntroduction: Limited information is available on the usefulness of the PIMATM analyser in predicting antiretroviral treatment eligibility and outcome in a primary healthcare clinic setting in disadvantaged communities in KwaZulu-Natal, South Africa. Materials and methods: The study was conducted under the eThekwini Health Unit, Durban, KwaZulu-Natal. Comparison of the enumeration of CD4+ T-cells in 268 patients using the PIMATM analyser and the predicate National Health Laboratory Services (NHLS) was undertaken during January to July 2013. Bland-Altman analysis to calculate bias and limits of agreement, precision and levels of clinical misclassification at various CD4+ T-cell count thresholds was performed. Results: There was high precision of the PIMATM control bead cartridges with low and normal CD4+ T-cell counts using three different PIMATM analysers (%CV < 5). Under World Health Organization (WHO) guidelines (≤ 500 cells/mm3), the sensitivity of the PIMATM analyser was 94%, specificity 78% and positive predictive value (PPV) 95%. There were 24 (9%) misclassifications, of which 13 were false-negative in whom the mean bias was 149 CD4+ T-cells/mm3. Most (87%) patients returned for their CD4 test result but only 67% (110/164) of those eligible (≤ 350 cells/mm3) were initiated on antiretroviral therapy (ART) with a time to treatment of 49 days (interquartile range [IQR], 42–64 days). Conclusion: There was adequate agreement between PIMATM analyser and predicate NHLS CD4+ T-cell count enumeration (≤ 500 cells/mm3) in adult HIV-positive individuals. The high PPV, sensitivity and acceptable specificity of the PIMATM analyser technology lend it as a reliable tool in predicting eligibility and rapid linkage to care in ART programmes. Keywords: HIV; Point of Care; PIMATM CD4+ T cell counts; antiretroviral therapy; prediction/eligibility; South Africahttps://sajhivmed.org.za/index.php/hivmed/article/view/444HIVPoint of CarePIMATM CD4+ T cell countsantiretroviral therapyprediction/eligibilitySouth Africa |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Mandisa Skhosana Shabashini Reddy Tarylee Reddy Siphelele Ntoyanto Elizabeth Spooner Gita Ramjee Noluthando Ngomane Anna Coutsoudis Photini Kiepiela |
spellingShingle |
Mandisa Skhosana Shabashini Reddy Tarylee Reddy Siphelele Ntoyanto Elizabeth Spooner Gita Ramjee Noluthando Ngomane Anna Coutsoudis Photini Kiepiela PIMA<sup>TM</sup> point-of-care testing for CD4 counts in predicting antiretroviral initiation in HIV-infected individuals in KwaZulu-Natal, Durban, South Africa Southern African Journal of HIV Medicine HIV Point of Care PIMATM CD4+ T cell counts antiretroviral therapy prediction/eligibility South Africa |
author_facet |
Mandisa Skhosana Shabashini Reddy Tarylee Reddy Siphelele Ntoyanto Elizabeth Spooner Gita Ramjee Noluthando Ngomane Anna Coutsoudis Photini Kiepiela |
author_sort |
Mandisa Skhosana |
title |
PIMA<sup>TM</sup> point-of-care testing for CD4 counts in predicting antiretroviral initiation in HIV-infected individuals in KwaZulu-Natal, Durban, South Africa |
title_short |
PIMA<sup>TM</sup> point-of-care testing for CD4 counts in predicting antiretroviral initiation in HIV-infected individuals in KwaZulu-Natal, Durban, South Africa |
title_full |
PIMA<sup>TM</sup> point-of-care testing for CD4 counts in predicting antiretroviral initiation in HIV-infected individuals in KwaZulu-Natal, Durban, South Africa |
title_fullStr |
PIMA<sup>TM</sup> point-of-care testing for CD4 counts in predicting antiretroviral initiation in HIV-infected individuals in KwaZulu-Natal, Durban, South Africa |
title_full_unstemmed |
PIMA<sup>TM</sup> point-of-care testing for CD4 counts in predicting antiretroviral initiation in HIV-infected individuals in KwaZulu-Natal, Durban, South Africa |
title_sort |
pima<sup>tm</sup> point-of-care testing for cd4 counts in predicting antiretroviral initiation in hiv-infected individuals in kwazulu-natal, durban, south africa |
publisher |
AOSIS |
series |
Southern African Journal of HIV Medicine |
issn |
1608-9693 2078-6751 |
publishDate |
2016-06-01 |
description |
Introduction: Limited information is available on the usefulness of the PIMATM analyser in predicting antiretroviral treatment eligibility and outcome in a primary healthcare clinic setting in disadvantaged communities in KwaZulu-Natal, South Africa.
Materials and methods: The study was conducted under the eThekwini Health Unit, Durban, KwaZulu-Natal. Comparison of the enumeration of CD4+ T-cells in 268 patients using the PIMATM analyser and the predicate National Health Laboratory Services (NHLS) was undertaken during January to July 2013. Bland-Altman analysis to calculate bias and limits of agreement, precision and levels of clinical misclassification at various CD4+ T-cell count thresholds was performed.
Results: There was high precision of the PIMATM control bead cartridges with low and normal CD4+ T-cell counts using three different PIMATM analysers (%CV < 5). Under World Health Organization (WHO) guidelines (≤ 500 cells/mm3), the sensitivity of the PIMATM analyser was 94%, specificity 78% and positive predictive value (PPV) 95%. There were 24 (9%) misclassifications, of which 13 were false-negative in whom the mean bias was 149 CD4+ T-cells/mm3. Most (87%) patients returned for their CD4 test result but only 67% (110/164) of those eligible (≤ 350 cells/mm3) were initiated on antiretroviral therapy (ART) with a time to treatment of 49 days (interquartile range [IQR], 42–64 days).
Conclusion: There was adequate agreement between PIMATM analyser and predicate NHLS CD4+ T-cell count enumeration (≤ 500 cells/mm3) in adult HIV-positive individuals. The high PPV, sensitivity and acceptable specificity of the PIMATM analyser technology lend it as a reliable tool in predicting eligibility and rapid linkage to care in ART programmes.
Keywords: HIV; Point of Care; PIMATM CD4+ T cell counts; antiretroviral therapy; prediction/eligibility; South Africa |
topic |
HIV Point of Care PIMATM CD4+ T cell counts antiretroviral therapy prediction/eligibility South Africa |
url |
https://sajhivmed.org.za/index.php/hivmed/article/view/444 |
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