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Multicountry Validation of SAMBA - A Novel Molecular Point-of-Care Test for HIV-1 Detection in Resource-Limited
Johnson Ondiek1, Zikulah Namukaya, Sekesai Mtapuri-Zinyowera
1*Kenya Medical Research Institute/US CDC Research and Public Health Collaboration (KEMRI-CDC), Kisumu, Kenya; †Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda; ‡National Microbiology Reference Laboratory, Harare, Zimbabwe; §Médecins Sans Frontières, Paris, France; ‖African Society for Laboratory Medicine, Addis Ababa, Ethiopia; ¶School of Medicine, Johns Hopkins University, Baltimore, MD; and #NHS Blood and Transplant, London, United Kingdom; **Central Public Health Laboratory, Ministry of Health, Kampala, Uganda; ††Diagnostics Development Unit, Department of Haematology, University of Cambridge, Great Chesterford, United Kingdom; ‡‡Baylor-Uganda, Paediatric Infectious Diseases Clinic, Mulago Hospital, Kampala, Uganda; §§Ministry of Health and Child Care, Harare, Zimbabwe; ‖‖Diagnostics for the Real World Ltd., Sunnyvale, CA.
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.
