1. Performance of the fourth-generation Bio-Rad GS HIV Combo Ag/Ab enzyme immunoassay for diagnosis of HIV infection in Southern Africa
- Author
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Piwowar-Manning, Estelle, Fogel, Jessica M, Richardson, Paul, Wolf, Shauna, Clarke, William, Marzinke, Mark A, Fiamma, Agnès, Donnell, Deborah, Kulich, Michal, Mbwambo, Jessie KK, Richter, Linda, Gray, Glenda, Sweat, Michael, Coates, Thomas J, and Eshleman, Susan H
- Subjects
Medical Microbiology ,Biomedical and Clinical Sciences ,Clinical Sciences ,Immunology ,Infectious Diseases ,Clinical Research ,Prevention ,HIV/AIDS ,Infection ,Africa ,Southern ,HIV ,HIV Antibodies ,HIV Antigens ,HIV Core Protein p24 ,HIV Infections ,HIV-1 ,HIV-2 ,Humans ,Immunoenzyme Techniques ,Reagent Kits ,Diagnostic ,Reproducibility of Results ,Sensitivity and Specificity ,Fourth-generation ,Diagnosis ,Africa ,Enzyme immunoassay ,Microbiology ,Virology ,Clinical sciences ,Medical microbiology - Abstract
BackgroundFourth-generation HIV assays detect both antigen and antibody, facilitating detection of acute/early HIV infection. The Bio-Rad GS HIV Combo Ag/Ab assay (Bio-Rad Combo) is an enzyme immunoassay that simultaneously detects HIV p24 antigen and antibodies to HIV-1 and HIV-2 in serum or plasma.ObjectiveTo evaluate the performance of the Bio-Rad Combo assay for detection of HIV infection in adults from Southern Africa.Study designSamples were obtained from adults in Soweto and Vulindlela, South Africa and Dar es Salaam, Tanzania (300 HIV-positive samples; 300 HIV-negative samples; 12 samples from individuals previously classified as having acute/early HIV infection). The samples were tested with the Bio-Rad Combo assay. Additional testing was performed to characterize the 12 acute/early samples.ResultsAll 300 HIV-positive samples were reactive using the Bio-Rad Combo assay; false positive test results were obtained for 10 (3.3%) of the HIV-negative samples (sensitivity: 100%, 95% confidence interval [CI]: 98.8-100%); specificity: 96.7%, 95% CI: 94.0-98.4%). The assay detected 10 of the 12 infections classified as acute/early. The two infections that were not detected had viral loads
- Published
- 2015