title: Evaluation of rapid HIV test kits on whole blood and development of rapid testing algorithm for voluntary testing and counseling centers in Ethiopia.
abstract: Five simple and rapid HIV antibody detection assays viz. Determine, Capillus, Oraquick, Unigold and Hemastrip were evaluated to examine their performance and to develop an alternative rapid test based testing algorithm for voluntary counseling and testing (VCT) in Ethiopia. All the kits were tested on whole blood, plasma and serum. The evaluation had three phases: Primary lab review, piloting at point of service and implementation. This report includes the results of the first two phases. A total of 2,693 specimens (both whole blood and plasma) were included in the evaluation. Results were compared to double Enzyme Linked Immuno-Sorbent Assay (ELISA) system. Discordant EIA results were resolved using Western Blot. The assays had very good sensitivities and specificities, 99-100%, at the two different phases of the evaluation. A 98-100% result agreement was obtained from those tested at VCT centers and National Referral Laboratory for AIDS (NRLA), in the quality control phase of the evaluation. A testing strategy yielding 100% [95% CI; 98.9-100.0] sensitivity was achieved by the sequential use of the three rapid test kits. Direct cost comparison showed serial testing algorithm reduces the cost of testing by over 30% compared to parallel testing in the current situation. Determine, Capillus/Oraquick (presence/absence of frefrigeration) and Unigold were recommended as screening, confirmation and tiebreaker tests, respectively.
authors.affiliation: Ethiopian Health and Nutrition Research Institute-National Referral Laboratory for AIDS.
authors.forename: Belete
authors.initials: B
authors.lastname: Tegbaru
authors.forename: Tsehaynesh
authors.initials: T
authors.lastname: Messele
authors.forename: Dawit
authors.initials: D
authors.lastname: Wolday
authors.forename: PhD Hailu
authors.initials: PH
authors.lastname: Meles
authors.forename: Desalegn
authors.initials: D
authors.lastname: Tesema
authors.forename: Hiwot
authors.initials: H
authors.lastname: Birhanu
authors.forename: Girma
authors.initials: G
authors.lastname: Tesfaye
authors.forename: Kyle B
authors.initials: KB
authors.lastname: Bond
authors.forename: Robert
authors.initials: R
authors.lastname: Martin
authors.forename: Mark A
authors.initials: MA
authors.lastname: Rayfield
authors.forename: Tadesse
authors.initials: T
authors.lastname: Wuhib
authors.forename: Makonnen
authors.initials: M
authors.lastname: Fekadu
mesh_terms: D015492:AIDS Serodiagnosis / Q000295:instrumentation / Q000379:methods*; D000465:Algorithms; D004797:Enzyme-Linked Immunosorbent Assay; D005002:Ethiopia; D015483:HIV Antibodies / Q000097:blood*; D015658:HIV Infections / Q000175:diagnosis*; D018023:HIV Seronegativity; D006679:HIV Seropositivity; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D007124:Immunoenzyme Techniques; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D012680:Sensitivity and Specificity; D013997:Time Factors
chemical_list: D015483:HIV Antibodies; D011933:Reagent Kits, Diagnostic