Multicountry Validation of SAMBA - A Novel Molecular Point-of-Care Test for HIV-1 Detection in Resource-Limited Setting. (1st October 2017)

• Record Type: Journal Article
• Authors: Ondiek, Johnson; Namukaya, Zikulah; Mtapuri-Zinyowera, Sekesai; Balkan, Suna; Elbireer, Ali; Ushiro Lumb, Ines; Kiyaga, Charles; Goel, Neha; Ritchie, Allyson; Ncube, Patience; Omuomu, Kenneth; Ndiege, Kenneth; Kekitiinwa, Adeodata; Mangwanya, Douglas; Fowler, Mary G.; Nadala, Lou; Lee, Helen
• Is Part Of: Journal of acquired immune deficiency syndromes. Volume 76:Number 2(2017)
• Publication Date: 2017-10-01
• Subjects: HIV-1 -- point-of-care -- early infant diagnosis -- nucleic acid test; AIDS (Disease) -- Periodicals; Acquired Immunodeficiency Syndrome -- Periodicals; AIDS (Disease); Periodicals; 616.9792005
• DOI: 10.1097/QAI.0000000000001476
• Languages: English
• ISSNs: 1525-4135

Abstract

Abstract : Introduction: Early diagnosis of HIV-1 infection and the prompt initiation of antiretroviral therapy are critical to achieving a reduction in the morbidity and mortality of infected infants. The Simple AMplification-Based Assay (SAMBA) HIV-1 Qual Whole Blood Test was developed specifically for early infant diagnosis and prevention of mother-to-child transmission programs implemented at the point-of-care in resource-limited settings. Methods: We have evaluated the performance of this test run on the SAMBA I semiautomated platform with fresh whole blood specimens collected from 202 adults and 745 infants in Kenya, Uganda, and Zimbabwe. Results were compared with those obtained with the Roche COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) HIV-1 assay as performed with fresh whole blood or dried blood spots of the same subjects, and discrepancies were resolved with alternative assays. Results: The performance of the SAMBA and CAP/CTM assays evaluated at 5 laboratories in the 3 countries was similar for both adult and infant samples. The clinical sensitivity, specificity, positive predictive value, and negative predictive value for the SAMBA test were 100%, 99.2%, 98.7%, and 100%, respectively, with adult samples, and 98.5%, 99.8%, 99.7%, and 98.8%, respectively, with infant samples. Discussion: Our data suggest that the SAMBA HIV-1 Qual Whole Blood Test would be effective for early diagnosis of HIV-1 infection in infants at point-of-care settings in sub-Saharan Africa.