SAMBA HIV semiquantitative test, a new point-of-care viral-load-monitoring assay for resource-limited settings.

Autor:	Ritchie AV; Diagnostic Development Unit, Department of Haematology, University of Cambridge, Cambridge, United Kingdom., Ushiro-Lumb I; Barts and The London NHS Trust, London, United Kingdom., Edemaga D; Médecins Sans Frontières, Paris, France., Joshi HA; Diagnostic Development Unit, Department of Haematology, University of Cambridge, Cambridge, United Kingdom., De Ruiter A; Department of Genitourinary Medicine and HIV, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom., Szumilin E; Médecins Sans Frontières, Paris, France., Jendrulek I; Department of Genitourinary Medicine and HIV, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom., McGuire M; Médecins Sans Frontières, Paris, France., Goel N; Diagnostic Development Unit, Department of Haematology, University of Cambridge, Cambridge, United Kingdom., Sharma PI; Diagnostic Development Unit, Department of Haematology, University of Cambridge, Cambridge, United Kingdom., Allain JP; Division of Transfusion Medicine, Department of Haematology, University of Cambridge, Cambridge, United Kingdom., Lee HH; Diagnostic Development Unit, Department of Haematology, University of Cambridge, Cambridge, United Kingdom hl207@cam.ac.uk.
Jazyk:	angličtina
Zdroj:	Journal of clinical microbiology [J Clin Microbiol] 2014 Sep; Vol. 52 (9), pp. 3377-83. Date of Electronic Publication: 2014 Jul 16.
DOI:	10.1128/JCM.00593-14
Abstrakt:	Routine viral-load (VL) testing of HIV-infected individuals on antiretroviral therapy (ART) is used to monitor treatment efficacy. However, due to logistical challenges, implementation of VL has been difficult in resource-limited settings. The aim of this study was to evaluate the performance of the SAMBA semi-Q (simple amplification-based assay semiquantitative test for HIV-1) in London, Malawi, and Uganda. The SAMBA semi-Q can distinguish between patients with VLs above and below 1,000 copies/ml. The SAMBA semi-Q was validated with diluted clinical samples and blinded plasma samples collected from HIV-1-positive individuals. SAMBA semi-Q results were compared with results from the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 test, v2.0. Testing of 96 2- to 10-fold dilutions of four samples containing HIV-1 subtype C as well as 488 samples from patients in the United Kingdom, Malawi, and Uganda yielded an overall accuracy for the SAMBA semi-Q of 99% (95% confidence interval [CI], 93.8 to 99.9%) and 96.9% (95% CI 94.9 to 98.3%), respectively, compared to to the Roche test. Analysis of VL data from patients in Malawi and Uganda showed that the SAMBA cutoff of 1,000 copies/ml appropriately distinguished treated from untreated individuals. Furthermore, analysis of the viral loads of 232 patients on ART in Malawi and Uganda revealed similar patterns for virological control, defined as either <1,000 copies/ml (SAMBA cutoff) or <5,000 copies/ml (WHO 2010 criterion; WHO, Antiretroviral Therapy for HIV Infection in Adults and Adolescents: Recommendations for a Public Health Approach, 2010). This study suggests that the SAMBA semi-Q has adequate concurrency with the gold standard measurements for viral load. This test can allow VL monitoring of patients on ART at the point of care in resource-limited settings. (Copyright © 2014 Ritchie et al.)
Databáze:	MEDLINE
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