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.
Bibliographical noteFunding Information:
The study was performed in accordance with the Declaration of Helsinki and participating countries’ research and ethical regulations. Ethical approval was obtained from the Scientific Steering and Ethical Review Committee of the Kenya Medical Research Institute–Center for Disease Control (KEMRI-CDC) in Kisumu, Kenya; from the Uganda National Council for Science and Technology for Arua District Hospital, Uganda; from the Joint Clinical Research Centre Ethics Committee, the Uganda National Council for Science and Technology, and the Institutional Review Board of Baylor College of Medicine for the Makerere University-Johns Hopkins University (MU-JHU) Research Collaboration and Baylor College of Medicine Children’s Foundation (Baylor-Uganda), Kampala; and from the Institutional Review Board of Harare Central Hospital and the Medical Research Council of Zimbabwe for the National Microbiology Reference Laboratory, Harare, Zimbabwe. All adult subjects provided written informed consent for study participation, with the parents or guardians of infant subjects also providing such consent.
Supported by a grant from the Children Investment Fund Foundation (CIFF) and UNITAID.
From the *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, Zim-babwe; §Médecins Sans Frontières, Paris, France; kAfrican 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; kkDiagnostics for the Real World Ltd., Sunnyvale, CA.
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- early infant diagnosis
- nucleic acid test