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J Clin Virol. 2014 Aug;60(4):399-401. doi: 10.1016/j.jcv.2014.04.025. Epub 2014 May 13.

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

Author information

1
Microbiology Department, Erasmus Hospital, Route de Lennik 808, 1070 Brussels, Belgium. Electronic address: Carlota.Montesinos@erasme.ulb.ac.be.
2
Microbiology Department, Erasmus Hospital, Route de Lennik 808, 1070 Brussels, Belgium. Electronic address: Joelle.Eykmans@erasme.ulb.ac.be.
3
AIDS Reference Laboratory, Microbiology Department, Erasmus Hospital, Route de Lennik 808, 1070 Brussels, Belgium. Electronic address: Marie-Luce.Delforge@erasme.ulb.ac.be.

Abstract

OBJECTIVES:

We have evaluated the recently Conformité Européenne (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 indeterminate 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 seroconversion 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 seroconversion 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.

KEYWORDS:

Geenius HIV1/2; HIV Western blot; HIV confirmatory tests

PMID:
24932737
DOI:
10.1016/j.jcv.2014.04.025
[Indexed for MEDLINE]

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