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

Hdl Handle:
http://hdl.handle.net/10144/326067
Title:
SAMBA HIV semi-quantitative test, a new point-of-care viral load monitoring assay for resource-limited settings
Authors:
Ritchie, Allyson V; Ushiro-Lumb, Ines; Edemaga, Daniel; Joshi, Hrishikesh A; De Ruiter, Annemiek; Szumilin, Elisabeth; Jendrulek, Isabelle; McGuire, Megan; Goel, Neha; Sharma, Pia I; Allain, Jean-Pierre; Lee, Helen H
Journal:
Journal of clinical microbiology
Abstract:
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 Test in London, Malawi, and Uganda. The SAMBA HIV-1 Semi-Q Test can distinguish between patients with VL above or below 1000 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 2-10 fold dilutions of four samples containing HIV-1 subtype C as well as 488 samples from patients in the United Kingdom, Malawi, and Uganda, respectively, yielded an overall accuracy for SAMBA Semi-Q of 99% (95% CI 93.8 - 99.9%) and 96.9% (95% CI 94.9 - 98.3%) respectively compared to Roche. Analysis of VL data from patients in Malawi and Uganda showed that the SAMBA cut-off of 1000 copies/ml appropriately distinguished treated from untreated individuals. Furthermore, analysis of the viral load of 232 patients on ART in Malawi and Uganda revealed similar patterns for virological control defined as either <1000 copies/ml (SAMBA cut-off) or <5000 copies/ml (WHO 2010 criterion). This study suggests that SAMBA Semi-Q has adequate concurrency with the gold standard measurements for viral load measurement. This test can allow VL monitoring of patients on ART at the point of care in resource-limited settings.
Issue Date:
16-Jul-2014
URI:
http://hdl.handle.net/10144/326067
DOI:
10.1128/JCM.00593-14
PubMed ID:
25031444
Language:
en
ISSN:
1098-660X
Appears in Collections:
HIV/AIDS

Full metadata record

DC FieldValue Language
dc.contributor.authorRitchie, Allyson Ven_GB
dc.contributor.authorUshiro-Lumb, Inesen_GB
dc.contributor.authorEdemaga, Danielen_GB
dc.contributor.authorJoshi, Hrishikesh Aen_GB
dc.contributor.authorDe Ruiter, Annemieken_GB
dc.contributor.authorSzumilin, Elisabethen_GB
dc.contributor.authorJendrulek, Isabelleen_GB
dc.contributor.authorMcGuire, Meganen_GB
dc.contributor.authorGoel, Nehaen_GB
dc.contributor.authorSharma, Pia Ien_GB
dc.contributor.authorAllain, Jean-Pierreen_GB
dc.contributor.authorLee, Helen Hen_GB
dc.date.accessioned2014-09-11T21:28:00Z-
dc.date.available2014-09-11T21:28:00Z-
dc.date.issued2014-07-16-
dc.identifier.citationSAMBA HIV semi-quantitative test, a new point-of-care viral load monitoring assay for resource-limited settings. 2014: J. Clin. Microbiol.en_GB
dc.identifier.issn1098-660X-
dc.identifier.pmid25031444-
dc.identifier.doi10.1128/JCM.00593-14-
dc.identifier.urihttp://hdl.handle.net/10144/326067-
dc.description.abstractRoutine 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 Test in London, Malawi, and Uganda. The SAMBA HIV-1 Semi-Q Test can distinguish between patients with VL above or below 1000 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 2-10 fold dilutions of four samples containing HIV-1 subtype C as well as 488 samples from patients in the United Kingdom, Malawi, and Uganda, respectively, yielded an overall accuracy for SAMBA Semi-Q of 99% (95% CI 93.8 - 99.9%) and 96.9% (95% CI 94.9 - 98.3%) respectively compared to Roche. Analysis of VL data from patients in Malawi and Uganda showed that the SAMBA cut-off of 1000 copies/ml appropriately distinguished treated from untreated individuals. Furthermore, analysis of the viral load of 232 patients on ART in Malawi and Uganda revealed similar patterns for virological control defined as either <1000 copies/ml (SAMBA cut-off) or <5000 copies/ml (WHO 2010 criterion). This study suggests that SAMBA Semi-Q has adequate concurrency with the gold standard measurements for viral load measurement. This test can allow VL monitoring of patients on ART at the point of care in resource-limited settings.en_GB
dc.languageENG-
dc.language.isoenen
dc.rightsPublished by the American Society for Microbiology - Archived on this site with kind permission from the American Society for Microbiologyen_GB
dc.subjectHIV/AIDSen_GB
dc.titleSAMBA HIV semi-quantitative test, a new point-of-care viral load monitoring assay for resource-limited settingsen
dc.identifier.journalJournal of clinical microbiologyen_GB

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