title: Point-of-Care Cepheid Xpert HIV-1 Viral Load Test in Rural African Communities Is Feasible and Reliable.
abstract: 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 log10copies/ml (95% confidence interval [CI], 0.26 to 0.40 log10copies/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 log10copies/ml. The POC Cepheid Xpert HIV-1 VL assay is a promising tool for monitoring patients on ART in southern Africa.
authors.affiliation: Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana sikhulilemoyo@gmail.com.|University of Stellenbosch, Division of Medical Virology, Faculty of Medicine & Health Sciences, Tygerberg, South Africa.
authors.forename: Sikhulile
authors.identifier: 0000-0003-3821-4592
authors.initials: S
authors.lastname: Moyo
authors.affiliation: Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.
authors.forename: Terence
authors.initials: T
authors.lastname: Mohammed
authors.affiliation: Harvard T. H. Chan School of Public Health, Department of Epidemiology, Boston, Massachusetts, USA.|Harvard T. H. Chan School of Public Health, Department of Immunology and Infectious Diseases, Boston, Massachusetts, USA.
authors.forename: Kathleen E
authors.initials: KE
authors.lastname: Wirth
authors.affiliation: Harvard T. H. Chan School of Public Health, Department of Biostatistics, Boston, Massachusetts, USA.
authors.forename: Melanie
authors.initials: M
authors.lastname: Prague
authors.affiliation: Bennett Statistical Consulting, Inc., Ballston Lake, New York, USA.
authors.forename: Kara
authors.initials: K
authors.lastname: Bennett
authors.affiliation: Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.|Harvard T. H. Chan School of Public Health, Department of Biostatistics, Boston, Massachusetts, USA.
authors.forename: Molly Pretorius
authors.initials: MP
authors.lastname: Holme
authors.affiliation: Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.
authors.forename: Lucy
authors.initials: L
authors.lastname: Mupfumi
authors.affiliation: Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.
authors.forename: Philemon
authors.initials: P
authors.lastname: Sebogodi
authors.affiliation: Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.
authors.forename: Natasha O
authors.initials: NO
authors.lastname: Moraka
authors.affiliation: Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.
authors.forename: Corretah
authors.initials: C
authors.lastname: Boleo
authors.affiliation: Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.
authors.forename: Comfort N
authors.initials: CN
authors.lastname: Maphorisa
authors.affiliation: Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.
authors.forename: Boitumelo
authors.initials: B
authors.lastname: Seraise
authors.affiliation: Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.|Harvard T. H. Chan School of Public Health, Department of Immunology and Infectious Diseases, Boston, Massachusetts, USA.
authors.forename: Simani
authors.initials: S
authors.lastname: Gaseitsiwe
authors.affiliation: Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.|Harvard T. H. Chan School of Public Health, Department of Immunology and Infectious Diseases, Boston, Massachusetts, USA.
authors.forename: Rosemary M
authors.initials: RM
authors.lastname: Musonda
authors.affiliation: Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.|Harvard T. H. Chan School of Public Health, Department of Immunology and Infectious Diseases, Boston, Massachusetts, USA.
authors.forename: Erik
authors.initials: E
authors.lastname: van Widenfelt
authors.affiliation: Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.|Harvard T. H. Chan School of Public Health, Department of Immunology and Infectious Diseases, Boston, Massachusetts, USA.|Massachusetts General Hospital, Departments of Medicine and Pediatrics, Boston, Massachusetts, USA.
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Powis
authors.affiliation: Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.
authors.forename: Tendani
authors.initials: T
authors.lastname: Gaolathe
authors.affiliation: Harvard T. H. Chan School of Public Health, Department of Epidemiology, Boston, Massachusetts, USA.|Harvard T. H. Chan School of Public Health, Department of Biostatistics, Boston, Massachusetts, USA.
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Tchetgen Tchetgen
authors.affiliation: Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.|Harvard T. H. Chan School of Public Health, Department of Immunology and Infectious Diseases, Boston, Massachusetts, USA.
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Makhema
authors.affiliation: Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.|Harvard T. H. Chan School of Public Health, Department of Immunology and Infectious Diseases, Boston, Massachusetts, USA.
authors.forename: Max
authors.initials: M
authors.lastname: Essex
authors.affiliation: Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.|Harvard T. H. Chan School of Public Health, Department of Immunology and Infectious Diseases, Boston, Massachusetts, USA.|Brigham and Women's Hospital, Division of Infectious Diseases, Boston, Massachusetts, USA.
authors.forename: Shahin
authors.initials: S
authors.lastname: Lockman
authors.affiliation: Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.|Harvard T. H. Chan School of Public Health, Department of Immunology and Infectious Diseases, Boston, Massachusetts, USA.
authors.forename: Vladimir
authors.initials: V
authors.lastname: Novitsky
mesh_terms: D023241:Antiretroviral Therapy, Highly Active; D001902:Botswana; D003430:Cross-Sectional Studies; D015658:HIV Infections / Q000175:diagnosis* / Q000188:drug therapy / Q000821:virology; D015497:HIV-1 / Q000235:genetics*; D006801:Humans; D000067716:Point-of-Care Testing; D012367:RNA, Viral / Q000097:blood* / Q000235:genetics; D012424:Rural Population; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000379:methods; D019562:Viral Load / Q000379:methods*
chemical_list: D012367:RNA, Viral