Background: HIV viral load testing is the standard of care for monitoring antiretroviral therapy. In resource-limited settings such as Kenya, access to HIV viral load monitoring is suboptimal due to reliance on centralized laboratory based in vitro diagnostics. Point of care technologies have the potential to improve access and reduce test to result turnaround time.
Objective: To determine the performance and usability of the mPIMA™ HIV-1/2 Viral Load (VL) test in point of care settings in Kenya.
Method: This was a cross-sectional study conducted amongst 568 HIV positive adults recruited from selected health facilities in Western Kenya between June and November 2018. Five hundred and sixty-six plasma samples (566) were tested successfully on Abbott™ RealTime HIV-1 quantitative test (reference assay) and mPIMA™ HIV-1/2 Viral Load test to determine diagnostic accuracy. Usability data was collected through simple structured questionnaires. Statistical analysis was done using Stata/MP Version 14 for Mac OSX. Concordance and misclassification values were calculated at the clinical cut-off of 1000 copies/ml.
Results: The positive, negative and overall agreement of the mPIMA™ HIV-1/2 V L test were 95.45% (95% CI 89.49-98.11%), 95.96% (95% CI 93.66-97.44%) and 95.86% respectively. All users (7/7, 100%) reported that the machine was easy to use and that the results interpretation and workflow were simple. The test to result turnaround time was 69 min. All clinicians (4/4, 100%) felt that a Point of care test would fit easily within their workflow and would facilitate decision-making. There were 44 (7.77%) errors in 566 tests; 38 (6.71%) were user related and four (4, 0.71%) were software related.
Conclusion: The mPIMA™ HIV-1/2 V L test can be used interchangeably with reference assays for HIV viral load monitoring. At the point of care, mPIMA™'s simple workflow, ease of use and short test to result turnaround time have the potential to improve access to HIV viral load monitoring.
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