Abstract

BackgroundPoint of Care testing (POCT) provides on-site, rapid, accessible results. With current South African anti-retroviral treatment guidelines, up to 4 fingersticks /patient/clinic visit could be required if utilizing POC. We determined the feasibility and accuracy of a nurse performing multiple POCT on multiple fingersticks followed by simplification of the process by performance of multiple POC on a single fingerstick.Method and FindingsRandom HIV positive adult patients presenting at a HIV treatment clinic in South Africa, for ART initiation/ monitoring, were approached to participate in the study between April-June 2012. Phase I: n=150 patients approached for multiple POCT on multiple fingersticks. Phase II: n=150 patients approached for multiple POCT on a single fingerstick. The following POC tests were performed by a dedicated nurse: PIMA (CD4), HemoCue (hemoglobin), Reflotron (alanine aminotransferase, creatinine). A venepuncture specimen was taken for predicate laboratory methodology. Normal laboratory ranges and Royal College of Pathologists Australasia (RCPA) allowable differences were used as guidelines for comparison. In 67% of participants, ≥3 tests were requested per visit. All POCT were accurate but ranged in variability. Phase I: Hemoglobin was accurate (3.2%CV) while CD4, alanine aminotransferase and creatinine showed increased variability (16.3%CV; 9.3%CV; 12.9%CV respectively). PIMA generated a misclassification of 12.4%. Phase II: Hemoglobin, alanine aminotransferase and creatinine showed good accuracy (3.2%CV, 8.7%CV, 6.4%CV respectively) with increased variability on CD4 (12.4%CV) but low clinical misclassification (4.1%). No trends were observed for the sequence in which POC was performed on a single fingerstick. Overall, PIMA CD4 generated the highest error rate (16-19%).ConclusionsMultiple POCT for ART initiation and/or monitoring can be performed practically by a dedicated nurse on multiple fingersticks. The process is as accurate as predicate methodology and can be simplified using a single fingerstick.

Highlights

  • The most important determinants of success in anti-retroviral treatment (ART) programs in South Africa rely on rapid HIV diagnosis, linkage to care, timely treatment initiation, and longterm retention of patients in care [1]

  • There was no significant difference in the two groups for patient age (p=0.64), gender (p=0.24) or CD4 count (p=0.65)

  • Of the total patients enrolled into the study, 67% required three or more tests per single visit based on standard ART guidelines at time of study (South African 2010 guidelines)

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Summary

Introduction

The most important determinants of success in anti-retroviral treatment (ART) programs in South Africa rely on rapid HIV diagnosis, linkage to care, timely treatment initiation, and longterm retention of patients in care [1]. Many HIV infected patients who need access to laboratory services for management, live in remote areas with limited access to even basic healthcare services [5] To meet these demands, decentralisation of laboratory testing through the implementation of Point-of-Care (POC) may provide a solution for those clinics that are low volume sites and are serviced by laboratories more than a few hours drive from the clinic. The vast numbers of patients in South Africa requiring ART initiation and monitoring increases the volumes of tests required, challenges of the feasibility of wide-scale implementation of multiple POC assays. Phase II: Hemoglobin, alanine aminotransferase and creatinine showed good accuracy (3.2%CV, 8.7%CV, 6.4%CV respectively) with increased variability on CD4 (12.4%CV) but low clinical misclassification (4.1%). The process is as accurate as predicate methodology and can be simplified using a single fingerstick

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