Multicountry Validation of SAMBA - A Novel Molecular Point-of-Care Test for HIV-1 Detection in Resource-Limited Setting

Johnson Ondiek, Zikulah Namukaya, Sekesai Mtapuri-Zinyowera, Suna Balkan, Ali Elbireer, Ines Ushiro Lumb, Charles Kiyaga, Neha Goel, Allyson Ritchie, Patience Ncube, Kenneth Omuomu, Kenneth Ndiege, Adeodata Kekitiinwa, Douglas Mangwanya, Mary G. Fowler, Lou Nadala, Helen Lee

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)e52-e57
JournalJournal of acquired immune deficiency syndromes
Volume76
Issue number2
DOIs
StatePublished - Oct 1 2017

Keywords

  • HIV-1
  • early infant diagnosis
  • nucleic acid test
  • point-of-care

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

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    Ondiek, J., Namukaya, Z., Mtapuri-Zinyowera, S., Balkan, S., Elbireer, A., Ushiro Lumb, I., Kiyaga, C., Goel, N., Ritchie, A., Ncube, P., Omuomu, K., Ndiege, K., Kekitiinwa, A., Mangwanya, D., Fowler, M. G., Nadala, L., & Lee, H. (2017). Multicountry Validation of SAMBA - A Novel Molecular Point-of-Care Test for HIV-1 Detection in Resource-Limited Setting. Journal of acquired immune deficiency syndromes, 76(2), e52-e57. https://doi.org/10.1097/QAI.0000000000001476