Evaluation of the Bio-Rad Geenius HIV 1/2 Assay as Part of a Confirmatory HIV Testing Strategy for Quebec, Canada: Comparison with Western Blot and Inno-Lia Assays.

Abstract

The rapid confirmatory Bio-Rad Geenius HIV 1/2 assay was evaluated as an alternative to the HIV-1 Western blot (WB) confirmatory assay. A total of 370 retrospective samples collected from 356 patients were tested. Sensitivity of the Geenius assay to detect HIV-1 and HIV-2 infections was 100% and 97%, respectively, and that of the WB assay was 86% and 39%, respectively. Geenius reduced the number of indeterminate results by 85% and exhibited a differentiation capacity for HIV-1 and HIV-2 of 100% and 89%, respectively. Three of 10 patients presenting with an early HIV infection (1 to 2 weeks before seroconversion by WB) were positive using Geenius. None of the HIV-negative samples were positive using Geenius or WB. However, 7% and 10% of them were indeterminate with Geenius and WB, respectively, leading to a specificity rate of 93% for Geenius and 90% for WB. Ninety cadaveric samples (54 negative, 23 HIV-1 positive, and 3 HIV-1 indeterminate) were tested with Geenius, leading to a sensitivity of 100%, a specificity of 96%, and an indeterminate rate of 4%. Our results indicate that the Bio-Rad Geenius HIV 1/2 rapid test exhibits better sensitivity to detect HIV-1 infections and better performance than WB to confirm and differentiate between HIV-1 and HIV-2 infections. The performance of this new confirmatory assay to detect early infections, to reduce the rate of indeterminate status, and to confirm HIV-1 infection in cadaveric blood samples makes Geenius a potent reliable alternative to the WB.