![]() This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.ĭata Availability: All relevant data are within the paper.įunding: This research was supported by a Grant-in-Aid for AIDS research from the Ministry of Health, Labour and Welfare of Japan (H28-AIDS-001), ( ). Received: Accepted: OctoPublished: October 31, 2018Ĭopyright: © 2018 Kondo et al. PLoS ONE 13(10):Įditor: Hiroshi Nishiura, Hokkaido University Graduate School of Medicine, JAPAN (2018) Comparative evaluation of the Geenius HIV 1/2 Confirmatory Assay and the HIV-1 and HIV-2 Western blots in the Japanese population. The adaptation of Geenius to the HIV testing algorithm may be advantageous for rapid diagnosis and the reduction of testing costs.Ĭitation: Kondo M, Sudo K, Sano T, Kawahata T, Itoda I, Iwamuro S, et al. Geenius is an attractive alternative to WB for confirmation and differentiation of HIV-1 and HIV-2 infections. The specificity of Geenius, NLB 1 and NLB 2 was 98.5%, 81.5% and 90.0%, respectively. The sensitivity of both Geenius and NLB 2 for HIV-2 positive samples was 100%. NLB 2 gave positive results in 12.3% of HIV-1 positive samples. Geenius provided more positive results in the samples from acute infections and detected positivity 0 to 32 days earlier in seroconversion panels than NLB 1. The sensitivity of Geenius and NLB 1 for HIV-1 positive samples was 99.3% and 98.6%, respectively. In addition, a total of 140 HIV negative samples containing 10 false-positives on screening tests were examined. A total of 166 HIV-1 positive samples (146 from patients with established HIV-1 infection and 20 from patients with acute infection), five HIV-1 seroconversion panels containing 21 samples and 30 HIV-2 positive samples were used. We made comprehensive comparison of the performance of Geenius and the Bio-Rad NEW LAV BLOT 1 and 2 (NLB 1 and 2) which are WB kits for HIV-1 and HIV-2, respectively, to examine if Geenius is a suitable alternative to these WB assays which are now being used in HIV testing in Japan. The Bio-Rad Geenius HIV-1/2 Confirmatory Assay (Geenius) has recently been approved and recommended for use in the revised guidelines for diagnosis of HIV infection by the Center for Disease Control and Prevention (USA). To address these problems, a new HIV testing algorithm and a more reliable confirmation and HIV-1/2 differentiation assay are required. ![]() Currently, confirmation tests of HIV infection in Japan are performed using Western blot (WB), but WB has several limitations including low sensitivity and cross-reactivity between HIV-1 and HIV-2 antibodies. Accurate diagnosis of earlier HIV infection is essential for treatment and prevention. ![]()
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