Evaluation of the Bio-Rad Geenius HIV-1/2 test as a confirmatory assay

Abstract

a b s t r a c t Objectives: We have evaluated the recently Conformite Europeenne (CE)-marked Bio-Rad Geenius human immunodeficiency virus (HIV)1/2 as a rapid and simple alternative to western blot for confirmation of HIV screening results. Methods: A total of 160 serum samples were tested: 44 HIV-1 reactive samples by a fourth-generation Murex HIV Ag/Ab and/or Vidas HIV Duo Ultra, five HIV-2 reactive samples, 15 HIV-1 non-B subtype samples and 11 confirmed HIV-1 early seroconversion samples, 72 nonreactive samples, eight indeter- minate samples by MP HIV BLOT 2.2 confirmed negative after follow-up and five low-reactive samples by enzyme immunoassay (EIA) negative by MP HIV BLOT 2.2. The samples were tested according to the manufacturer's guidelines. Results: The overall sensitivity for Bio-Rad Geenius HIV1/2 assay was 92%. Five out of 11 early serocon- version samples were tested positive, four negative and two indeterminate. All HIV-1 non-B subtype samples were tested positive. Two out of the five HIV-2 reactive samples were tested positive HIV-2, two positive HIV-2 with HIV-1 cross-reaction and one HIV positive untypable. After excluding early sero- conversion samples, the sensitivity of Bio-Rad Geenius HIV1/2 assay reached 100%. Overall specificity was 96%. All HIV negative serums by fourth-generation EIA were tested negative. All five low-reactive samples by EIA, negative by HIV BLOT 2.2 were tested negative by Bio-Rad Geenius HIV1/2. Two out of the eight indeterminate samples by MP HIV BLOT 2.2 that were confirmed negative after follow-up were tested indeterminate and one invalid, the other five were negative. After excluding these last 13 samples, the specificity of Bio-Rad Geenius HIV1/2 assay reached 100%. In comparison with MP HIV BLOT 2.2, the Bio-Rad Geenius HIV1/2 assay was markedly time saving, allowed full traceability, automatic reading and interpretation. Conclusions: The Bio-Rad Geenius HIV1/2 confirmatory system represents a reliable alternative to other confirmatory assays in HIV testing algorithms and provides clear improvement in quality management. © 2014 Elsevier B.V. All rights reserved.