title: Performance of six commercial enzyme immunoassays and two alternative HIV-testing algorithms for the diagnosis of HIV-1 infection in Kisumu, Western Kenya.
abstract: 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.
authors.affiliation: US-Centers for Disease Control and Prevention, Kisumu, Kenya. Czeh@ke.cdc.gov
authors.forename: C
authors.initials: C
authors.lastname: Zeh
authors.forename: B
authors.initials: B
authors.lastname: Oyaro
authors.forename: H
authors.initials: H
authors.lastname: Vandenhoudt
authors.forename: P
authors.initials: P
authors.lastname: Amornkul
authors.forename: A
authors.initials: A
authors.lastname: Kasembeli
authors.forename: P
authors.initials: P
authors.lastname: Bondo
authors.forename: D
authors.initials: D
authors.lastname: Mwaengo
authors.forename: T K
authors.initials: TK
authors.lastname: Thomas
authors.forename: C
authors.initials: C
authors.lastname: Hart
authors.forename: K F
authors.initials: KF
authors.lastname: Laserson
authors.forename: P
authors.initials: P
authors.lastname: Ondoa
authors.forename: J N
authors.initials: JN
authors.lastname: Nkengasong
mesh_terms: D015492:AIDS Serodiagnosis / Q000379:methods*; D000465:Algorithms; D015153:Blotting, Western; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D015483:HIV Antibodies / Q000097:blood*; D015658:HIV Infections / Q000175:diagnosis* / Q000453:epidemiology / Q000276:immunology / Q000821:virology; D015497:HIV-1 / Q000276:immunology*; D015498:HIV-2 / Q000276:immunology; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods*; D007630:Kenya / Q000453:epidemiology; D011237:Predictive Value of Tests; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity
chemical_list: D015483:HIV Antibodies; D011933:Reagent Kits, Diagnostic