Abstract

BackgroundHealthcare workers’ acceptance of and ability to perform point-of-care testing is important for reliable and accurate results. The Alere Pima™ CD4 assay (Pima CD4) is the CD4 point-of-care test for HIV management in Tanzania.ObjectivesTo evaluate healthcare workers’ acceptance and performance of Pima CD4 testing.MethodsThe study was implemented in five high volume sites in Dar es Salaam, Tanzania, in 2011. Trained healthcare workers performed Pima testing using three whole-blood specimens collected from each patient: venous blood, fingerstick blood directly applied to a Pima cartridge (capillary-direct), and fingerstick blood collected in a microtube (capillary-microtube). Using a semi-structured interview guide, we interviewed 11 healthcare workers about specimen collection methods and Pima CD4 acceptability. Quantitative responses were analysed using descriptive statistics. Open-ended responses were summarised by thematic areas. Pima CD4 results were analysed to determine variation between cadres.ResultsHealthcare workers found Pima CD4 user-friendly and recommended its use in low volume, peripheral facilities. Both venous and capillary-direct blood were considered easy to collect, with venous preferred. Advantages noted with venous and capillary-microtube methods were the ability to retest, perform multiple tests, or delay testing. Pima CD4 results were trusted by the healthcare workers and were in agreement with laboratory Pima testing.ConclusionIn this point-of-care testing setting, the Pima CD4 assay was accepted by healthcare workers. Both venous and fingerstick capillary blood specimens can be used with Pima CD4, but fingerstick methods may require more intensive training on technique to minimise variation in results and increase acceptability.

Highlights

  • Testing for CD4 count was previously a widely used method for determining the timing of antiretroviral therapy (ART) initiation among HIV-positive individuals.[1,2,3] In 2016, the World Health Organization recommended ART initiation for all HIV-positive adults and children, regardless of CD4 count

  • During this study, the quality of the specimens collected was acceptable for Pima CD4 testing, with only a few compromised specimens occurring with fingerstick collection

  • Our study indicated that various cadres could perform the Pima CD4 assay and achieve similar results as would laboratorians

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Summary

Introduction

Testing for CD4 count was previously a widely used method for determining the timing of antiretroviral therapy (ART) initiation among HIV-positive individuals.[1,2,3] In 2016, the World Health Organization recommended ART initiation for all HIV-positive adults and children, regardless of CD4 count. In many resource-limited settings, the availability of CD4 testing is challenging due to poor laboratory infrastructure, human resource limitations, instrument maintenance issues, supply chain failures, poor result reporting systems, and insufficient means to ensure quality of testing.[5,6,7,8] These challenges, coupled with inefficient specimen referral systems, previously resulted in delayed treatment decisions at clinics.[9,10,11] High attrition rates between HIV diagnosis and ART initiation have been observed with laboratory-based CD4 testing.[9,10,11,12] patients may have progressed to severe or advanced clinical stages of HIV before seeking treatment, dramatically decreasing survival outcomes.[9,10] While the current Tanzanian guidelines have removed the need for CD4 testing to initiate ART, they still recommend baseline CD4 testing to assess the need for cotrimoxazole preventive therapy and monitoring for any patient with a CD4. The Alere PimaTM CD4 assay (Pima CD4) is the CD4 point-of-care test for HIV management in Tanzania

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