Original Research

PIMATM point-of-care testing for CD4 counts in predicting antiretroviral initiation in HIV-infected individuals in KwaZulu-Natal, Durban, South Africa

Mandisa Skhosana, Shabashini Reddy, Tarylee Reddy, Siphelele Ntoyanto, Elizabeth Spooner, Gita Ramjee, Noluthando Ngomane, Anna Coutsoudis, Photini Kiepiela
Southern African Journal of HIV Medicine | Vol 17, No 1 | a444 | DOI: https://doi.org/10.4102/sajhivmed.v17i1.444 | © 2016 Mandisa Skhosana, Shabashini Reddy, Tarylee Reddy, Siphelele Ntoyanto, Elizabeth Spooner, Gita Ramjee, Noluthando Ngomane, Anna Coutsoudis, Photini Kiepiela | This work is licensed under CC Attribution 4.0
Submitted: 07 November 2015 | Published: 24 June 2016

About the author(s)

Mandisa Skhosana, Department of Paediatrics and Child Health, University of KwaZulu-Natal, South Africa; Medical Research Council of South Africa, HIV Prevention Research Unit, South Africa
Shabashini Reddy, Medical Research Council of South Africa, HIV Prevention Research Unit, South Africa
Tarylee Reddy, Medical Research Council of South Africa, Biostatistics Unit, South Africa
Siphelele Ntoyanto, Medical Research Council of South Africa, HIV Prevention Research Unit, South Africa
Elizabeth Spooner, Department of Paediatrics and Child Health, University of KwaZulu-Natal, South Africa; Medical Research Council of South Africa, HIV Prevention Research Unit, South Africa
Gita Ramjee, Medical Research Council of South Africa, HIV Prevention Research Unit, South Africa
Noluthando Ngomane, eThekwini Health Unit, eThekwini Municipality, South Africa
Anna Coutsoudis, Department of Paediatrics and Child Health, University of KwaZulu-Natal, South Africa
Photini Kiepiela, Medical Research Council of South Africa, HIV Prevention Research Unit, South Africa


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Abstract

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


Keywords

HIV; Point of Care; PIMATM CD4+ T cell counts; antiretroviral therapy; prediction/eligibility; South Africa

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