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J Clin Microbiol. 2016 Dec;54(12):3050-3055. Epub 2016 Oct 12.

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

Author information

  • 1Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana
  • 2University of Stellenbosch, Division of Medical Virology, Faculty of Medicine & Health Sciences, Tygerberg, South Africa.
  • 3Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.
  • 4Harvard T. H. Chan School of Public Health, Department of Epidemiology, Boston, Massachusetts, USA.
  • 5Harvard T. H. Chan School of Public Health, Department of Immunology and Infectious Diseases, Boston, Massachusetts, USA.
  • 6Harvard T. H. Chan School of Public Health, Department of Biostatistics, Boston, Massachusetts, USA.
  • 7Bennett Statistical Consulting, Inc., Ballston Lake, New York, USA.
  • 8Massachusetts General Hospital, Departments of Medicine and Pediatrics, Boston, Massachusetts, USA.
  • 9Brigham and Women's Hospital, Division of Infectious Diseases, Boston, Massachusetts, USA.


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. We compared the performance of the Cepheid Xpert HIV-1 VL assay against the laboratory-based Abbott m2000sp/m2000rt assay (Abbott assay). ART-naive individuals participating in the Botswana Combination Prevention Project in 20 communities provided EDTA-blood specimens during household surveys. Both the POC Xpert HIV-1 VL and Abbott assays were performed on specimens sampled from 277 individuals. We found a high correlation between the Xpert HIV-1 VL and Abbott assay results (r2 = 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 log10 copies/ml (95% confidence interval [CI], 0.26 to 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 to 93.1%), with a sensitivity of 98.6% (95% CI, 97.2 to 100%). The two methods agreed on their detectability of HIV-1 RNA (>40 copies/ml) at 97.1% (95% CI, 95.5 to 98.7%), with a sensitivity of 99.6% (95% CI, 97.2 to 100%). 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.

[Available on 2017-06-01]
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