Performance of six commercial enzyme immunoassays and two alternative HIV-testing algorithms for the diagnosis of HIV-1 infection in Kisumu, Western Kenya
Journal of Virological Methods
US-Centers for Disease Control and Prevention (CDC), Kisumu, Kenya; Division of HIV/AIDS Prevention, National Center for HIV, Viral Hepatitis, STD and TB Prevention, CDC, Atlanta, GA, United States; Kenya Medical Research Institute, Center for Global Health Research, Kisumu, Kenya; Global AIDS Program, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, CDC, Atlanta, GA, United States; US-Centers for Disease Control and Prevention, Center for Global Health, Atlanta, GA, United States; Institute of Tropical Medicine, Antwerp, Belgium; Center for Poverty-related Communicable Diseases (CPCD), Center for Infection and Immunity (CINIMA), Department of Internal Medicine, Academic Medical Center, University of Amsterdam, Amsterdam Institute for Global Health and Development (AIGHD), Netherlands
Performances of serological parallel and serial testing algorithms were analyzed using a combination of three ELISA and three rapid tests for the confirmation of HIV infection. Each was assessed individually for their sensitivity and specificity on a blinded panel of 769 retrospective sera of known HIV status. Western blot was used as a confirmatory assay for discordant results. Subsequently, one parallel and one serial testing algorithm were assessed on a new panel of 912 HIV-positive and negative samples. Individual evaluation of the ELISAs and rapid tests indicated a sensitivity of 100% for all assays except Uni-Gold with 99.7%. The specificities ranged from 99.1% to 99.4% for rapid assays and from 97.5% to 99.1% for ELISAs. A parallel and serial testing algorithms using Enzygnost and Vironostika, and Determine followed by Uni-Gold respectively, showed 100% sensitivity and specificity. The cost for testing 912 samples was US$4.74 and US$ 1.9 per sample in parallel and serial testing respectively. Parallel or serial testing algorithm yielded a sensitivity and specificity of 100%. This alternative algorithm is reliable and reduces the occurrence of both false negatives and positives. The serial testing algorithm was more cost effective for diagnosing HIV infections in this population. © 2011.
antigen p24; glycoprotein gp 41; Human immunodeficiency virus antigen; immunoglobulin G antibody; immunoglobulin M antibody; recombinant protein; adolescent; adult; agglutination test; algorithm; analytical error; article; controlled clinical trial; controlled study; cost control; cost effectiveness analysis; diagnostic accuracy; diagnostic test; diagnostic test accuracy study; enzyme linked immunosorbent assay; false positive result; human; Human immunodeficiency virus 1 infection; immunoaffinity chromatography; intermethod comparison; Kenya; major clinical study; parallel testing algorithm; predictive value; priority journal; sensitivity and specificity; serial testing algorithm; serodiagnosis; Western blotting; AIDS Serodiagnosis; Algorithms; Blotting, Western; Enzyme-Linked Immunosorbent Assay; HIV Antibodies; HIV Infections; HIV-1; HIV-2; Humans; Immunoenzyme Techniques; Kenya; Predictive Value of Tests; Reagent Kits, Diagnostic; Sensitivity and Specificity; Human immunodeficiency virus 1