Pascoe S.J.S., Langhaug L.F., Mudzori J., Burke E., Hayes R., Cowan F.M.
IDEU, Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, United Kingdom; Royal Free and University College Medical School, London, United Kingdom; National Microbiology Reference Laboratory, Harare, Zimbabwe; Comforce/CDC Zimbabwe, Harare, Zimbabwe
Pascoe, S.J.S., IDEU, Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, United Kingdom; Langhaug, L.F., Royal Free and University College Medical School, London, United Kingdom; Mudzori, J., National Microbiology Reference Laboratory, Harare, Zimbabwe; Burke, E., Comforce/CDC Zimbabwe, Harare, Zimbabwe; Hayes, R., IDEU, Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, United Kingdom; Cowan, F.M., Royal Free and University College Medical School, London, United Kingdom
The objective of this study was to validate the use of OraQuick® ADVANCE Rapid HIV-1/2 Antibody test (OraSure Technologies Inc., Bethlehem, PA) on oral fluid for a population-based HIV prevalence survey of rural youth in southeast Zimbabwe. The evaluation was conducted in patients presenting for voluntary counseling and testing at rural clinics. Each participant provided an oral fluid sample tested using OraQuick® ADVANCE. In addition, dried blood specimens were collected and tested blind at the National Microbiology Reference Laboratory in Harare using two enzyme-linked immunosorbent assays (ELISA; Vironostika®, Biomérieux BV, Boxtel, The Netherlands and Ani Labsystems, Ltd., Vantaa, Finland) with confirmatory Western blot (MP Diagnostics [formerly Genelabs Diagnostics], Medical Technology Promedt Consulting GMBH, St. Ingbert, Germany) for samples with discrepant results. Diagnostic accuracy of the oral fluid assay was determined against the ELISA/Western blot algorithm as gold standard. Five hundred and ninety-one participants took part in the study between February and July 2006. Sensitivity of the test on oral fluid was 100% (95% confidence interval [CI]: 97.9-100), and specificity was 100% (95% CI: 99.1-100). HIV prevalence based on the reference standard was 29.8% (95% CI: 26.1-33.5). This is one of the first validations of this rapid assay on oral fluid conducted in a general population to be reported in Africa. While there are some limitations with the assay (e.g., unlikely to detect those in early stages of HIV infection or with reduced viral load; altered accuracy in pregnancy) these limitations also apply to other rapid assays. The results showed the assay to be 100% accurate in determining HIV status, performed well in field settings, and can be considered suitable for use in epidemiologic surveys aiming to estimate HIV prevalence in general populations. © Copyright 2009, Mary Ann Liebert, Inc.
adolescent; adult; aged; article; blood sampling; controlled study; counseling; diagnostic accuracy; diagnostic test; enzyme linked immunosorbent assay; female; field study; gold standard; health survey; human; Human immunodeficiency virus infection; immunoassay; major clinical study; male; oral fluid rapid test; outpatient department; prevalence; sensitivity and specificity; validation study; Western blotting; Zimbabwe; Adolescent; Adult; Aged; Aged, 80 and over; AIDS Serodiagnosis; Algorithms; Blotting, Western; Enzyme-Linked Immunosorbent Assay; Female; HIV Infections; HIV-1; Humans; Male; Middle Aged; Prevalence; Reagent Kits, Diagnostic; Rural Population; Saliva; Sensitivity and Specificity; Young Adult; Zimbabwe