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Performance of the fourth-generation Bio-Rad GS HIV Combo Ag/Ab enzyme immunoassay for diagnosis of HIV infection in Southern Africa

E. Piwowar-Manning, JM. Fogel, P. Richardson, S. Wolf, W. Clarke, MA. Marzinke, A. Fiamma, D. Donnell, M. Kulich, JK. Mbwambo, L. Richter, G. Gray, M. Sweat, TJ. Coates, SH. Eshleman,

. 2015 ; 62 (-) : 75-9. [pub] 20141127

Language English Country Netherlands

Document type Journal Article, Research Support, N.I.H., Extramural

Persistent link   https://www.medvik.cz/link/bmc16000421

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.

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$a BACKGROUND: Fourth-generation HIV assays detect both antigen and antibody, facilitating detection of acute/early HIV infection. The Bio-Rad GS HIV Combo Ag/Ab assay (Bio-Rad Combo) is an enzyme immunoassay that simultaneously detects HIV p24 antigen and antibodies to HIV-1 and HIV-2 in serum or plasma. OBJECTIVE: To evaluate the performance of the Bio-Rad Combo assay for detection of HIV infection in adults from Southern Africa. STUDY DESIGN: Samples were obtained from adults in Soweto and Vulindlela, South Africa and Dar es Salaam, Tanzania (300 HIV-positive samples; 300 HIV-negative samples; 12 samples from individuals previously classified as having acute/early HIV infection). The samples were tested with the Bio-Rad Combo assay. Additional testing was performed to characterize the 12 acute/early samples. RESULTS: All 300 HIV-positive samples were reactive using the Bio-Rad Combo assay; false positive test results were obtained for 10 (3.3%) of the HIV-negative samples (sensitivity: 100%, 95% confidence interval [CI]: 98.8-100%); specificity: 96.7%, 95% CI: 94.0-98.4%). The assay detected 10 of the 12 infections classified as acute/early. The two infections that were not detected had viral loads<400 copies/mL; one of those samples contained antiretroviral drugs consistent with antiretroviral therapy. CONCLUSIONS: The Bio-Rad Combo assay correctly classified the majority of study specimens. The specificity reported here may be higher than that seen in other settings, since HIV-negative samples were pre-screened using a different fourth-generation test. The assay also had high sensitivity for detection of acute/early infection. False-negative test results may be obtained in individuals who are virally suppressed.
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$a Fogel, Jessica M $u Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
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$a Richardson, Paul $u Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
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$a Wolf, Shauna $u Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
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$a Clarke, William $u Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
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$a Marzinke, Mark A $u Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
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$a Fiamma, Agnès $u Program in Global Health, University of California at Los Angeles, Los Angeles, CA, USA.
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$a Donnell, Deborah $u Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Department of Global Health, University of Washington, Seattle, WA, USA.
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$a Kulich, Michal $u Department of Probability and Statistics, Faculty of Mathematics and Physics, Charles University, Prague, Czech Republic.
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$a Mbwambo, Jessie K K $u Muhimbili University of Health and Allied Sciences, Muhimbili University Teaching Hospital, Dar es Salaam, Tanzania.
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$a Richter, Linda $u DST-NRF Centre of Excellence in Human Development, Universities of the Witwatersrand and KwaZulu-Natal, South Africa; Human Sciences Research Council, Durban, South Africa.
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$a Gray, Glenda $u Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, University of the Witwatersrand, Johannesburg, South Africa; South African Medical Research Council, Cape Town, South Africa.
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$a Sweat, Michael $u Department of Psychiatry and Behavioral Sciences, The Medical University of South Carolina, Charleston, SC, USA.
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$a Coates, Thomas J $u Center for World Health, David Geffen School of Medicine and UCLA Health, Los Angeles, CA, USA.
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$a Eshleman, Susan H $u Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: seshlem@jhmi.edu.
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