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
; 62: 75-9, 2015 Jan.
Article
en En
| MEDLINE
| ID: mdl-25542477
ABSTRACT
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. STUDYDESIGN:
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.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Juego de Reactivos para Diagnóstico
/
Anticuerpos Anti-VIH
/
Antígenos VIH
/
Infecciones por VIH
/
Técnicas para Inmunoenzimas
/
VIH
Tipo de estudio:
Diagnostic_studies
Límite:
Humans
País/Región como asunto:
Africa
Idioma:
En
Revista:
J Clin Virol
Asunto de la revista:
VIROLOGIA
Año:
2015
Tipo del documento:
Article
País de afiliación:
Estados Unidos