Multicountry validation of SAMBA - a novel molecular point-of-care test for HIV-1 detection in resource-limited setting
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Date
2017
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
Wolters Kluwer Health, Inc
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.
Description
Keywords
HIV-1, Point-of-care, Early infant diagnosis, Nucleic acid test
Citation
Ondiek, J., Namukaya, Z., Mtapuri-Zinyowera, S., Balkan, S., Elbireer, A., Lumb, I. U., ... & Lee, H. (2017). Multicountry validation of SAMBA-A novel molecular point-of-care test for HIV-1 detection in resource-limited setting. JAIDS Journal of Acquired Immune Deficiency Syndromes, 76(2), e52-e57.