HPTN Bibliographic Record

Piwowar-Manning E, Fogel JM, Richardson P, Wolf S, Clarke W, Marzinke MA, Fiamma A, Donnell D, Kulich M, Mbwambo JK, Richter L, Gray G, Sweat M, Coates TJ, Eshleman SH. Performance of the fourth-generation Bio-Rad GS HIV Combo Ag/Ab enzyme immunoassay for diagnosis of HIV infection in Southern Africa. J Clin Virol. 2015, 62: 75-9. PMC4319362
BACKGROUND: Fourth-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. OBJECTIVE: To evaluate the performance of the Bio-Rad Combo assay for detection of HIV infection in adults from Southern Africa. STUDY DESIGN: Samples 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. RESULTS: All 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<400 copies/mL; one of those samples contained antiretroviral drugs consistent with antiretroviral therapy. CONCLUSIONS: The Bio-Rad Combo assay correctly classified the majority of study specimens. The specificity reported here may be higher than that seen in other settings, since HIV-negative samples were pre-screened using a different fourth-generation test. The assay also had high sensitivity for detection of acute/early infection. False-negative test results may be obtained in individuals who are virally suppressed.