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Point-of-care Cepheid Xpert HIV-1 Viral Load Test in Rural African Communities is Feasible and Reliable.

Point-of-care Cepheid Xpert HIV-1 Viral Load Test in Rural African Communities is Feasible and Reliable.
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Moyo S, Mohammed T, Wirth KE, Prague M, Bennett K, Holme MP, Mupfumi L, Sebogodi P, Moraka NO, Boleo C, Maphorisa CN, Seraise B, Gaseitsiwe S, Musonda RM, van Widenfelt E, Powis KM, Gaolathe T, Tchetgen Tchetgen EJ, Makhema JM, Essex M, Lockman S, Novitsky V,


Moyo S, Mohammed T, Wirth KE, Prague M, Bennett K, Holme MP, Mupfumi L, Sebogodi P, Moraka NO, Boleo C, Maphorisa CN, Seraise B, Gaseitsiwe S, Musonda RM, van Widenfelt E, Powis KM, Gaolathe T, Tchetgen Tchetgen EJ, Makhema JM, Essex M, Lockman S, Novitsky V, (click to view)

Moyo S, Mohammed T, Wirth KE, Prague M, Bennett K, Holme MP, Mupfumi L, Sebogodi P, Moraka NO, Boleo C, Maphorisa CN, Seraise B, Gaseitsiwe S, Musonda RM, van Widenfelt E, Powis KM, Gaolathe T, Tchetgen Tchetgen EJ, Makhema JM, Essex M, Lockman S, Novitsky V,

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Journal of clinical microbiology 2016 Oct 12() pii

Abstract
BACKGROUND
Routine monitoring of HIV-1 RNA, or viral load (VL) in patients on antiretroviral therapy (ART) is important, but there are multiple impediments to VL testing in resource-constrained settings. An accurate point-of-care (POC) HIV-1 VL test could alleviate many of these challenges.

METHODS
We compared the performance of the Cepheid Xpert® HIV-1 VL against the laboratory-based Abbott m2000sp/m2000rt assay (Abbot assay). ART-naïve individuals participating in the Botswana Combination Prevention Project in 20 communities provided EDTA blood specimens during household surveys.

RESULTS
Both POC Xpert HIV-1 VL and Abbott assays were performed on specimens sampled from 277 individuals. We found high correlation between the Xpert HIV-1 VL and Abbott assay results (r(2) = 0.92; p<0.001). The overall mean difference in the HIV-1 RNA values obtained by Xpert HIV-1 VL assay and Abbott assay was 0.34 (95%CI: 0.26-0.40) log10 copies/mL (p<0.001). Using a clinically relevant level of 1,000 copies/mL as a threshold, agreement was 90.6% (95%CI 87.9-93.1%) with sensitivity of 98.6% (95%CI 97.2-100%). Both methods agreed on detectability of HIV-1 RNA (>40 copies/mL) in 97.1% (95%CI 95.5-98.7%) with sensitivity of 99.6% (95%CI 97.2-100%).

CONCLUSIONS
The POC Cepheid Xpert HIV-1 VL assay showed high agreement and accuracy with a laboratory-based method of HIV-1 RNA testing. The POC Xpert HIV-1 VL assay tended to overestimate HIV-1 VL, although the difference was below a clinically relevant threshold of 0.5 log10 copies/mL. The POC Cepheid Xpert HIV-1 VL assay is a promising tool for monitoring patients on ART in Southern Africa.

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