Abstract
BackgroundNEW LAV BLOT I and II (LAV I and LAV II), they were only option for human immunodeficiency virus (HIV) confirmatory test, following HIV screening test using HIV Ag/Ab combination test in Japan. We evaluated the performance of Geenius HIV-1/2 Confirmatory Assay (Geenius), both as a confirmatory test and for differentiation between HIV-1 and HIV-2, in comparison with LAV I and LAV II.MethodsEighty-nine HIV-1-positive plasma specimens, one anti-HIV-1 low-titer performance panel, 10 seroconversion panels, and two anti-HIV-1/2 combo performance panels were tested. The results were read with the Geenius Reader and by visual reading.ResultsAll 89 HIV-1-positive plasma specimens were identified as HIV-1-positive using Geenius; this 100% success rate was superior to that with LAV I (95.5% using WHO criteria, 98.9% using CDC criteria). The HIV-1-positive specimens showed low cross-reactivity with HIV-2 lines in Geenius. The sensitivity of Geenius for HIV-1 detection was the same as or greater than that of LAV I, but less than that of Genscreen HIV Ag-Ab ULT, in our analysis of the commercial performance and seroconversion panels. In contrast, five of the 13 HIV-2-positive specimens that had been identified as HIV-positive untypable by visual reading because of their cross-reactivity to HIV-1 lines were successfully identified by the Geenius Reader as HIV-2-positive with cross-reactivity.ConclusionsGeenius provides strong performance for HIV confirmatory tests and HIV-1 differentiation tests. However, when visual reading is used, its performance in HIV-2 differentiation is less reliable. Because HIV-2 infection has been sporadically reported in Japan, the use of the Geenius Reader is preferable to ensure more reliable HIV-1/HIV-2 differentiation.
Highlights
NEW LAV BLOT I and II (LAV I and LAV II), they were only option for human immunodeficiency virus (HIV) confirmatory test, following HIV screening test using HIV Ag/Ab combination test in Japan
As sporadic cases of HIV-2 infection have been reported in Japan since the 2000s [1,2,3], the roles of LAV I and LAV II have become more important for HIV-1/ HIV-2 differentiation
When the Geenius Reader was used, Malloch et al reported that 52 out of 53 (98.1%) HIV-2-positive specimens were identified as HIV-2-positive [15], while Montesinos et al reported that four out of five HIV-2-positive specimens were identified as HIV-2-positive [10]. These results indicate that Geenius offers strong performance for HIV-2 diagnosis when it is used with the Geenius Reader
Summary
NEW LAV BLOT I and II (LAV I and LAV II), they were only option for human immunodeficiency virus (HIV) confirmatory test, following HIV screening test using HIV Ag/Ab combination test in Japan. In Japan, specimens that are detected as human immunodeficiency virus (HIV)-positive via the screening test, using HIV Ag/Ab combination test, are subjected to a confirmatory test using western blot test. As sporadic cases of HIV-2 infection have been reported in Japan since the 2000s [1,2,3], the roles of LAV I and LAV II have become more important for HIV-1/ HIV-2 differentiation. HIV-2 infections are often misclassified as HIV-1 while using the HIV-1 western blot [5,6,7]. The process of western blotting is complicated, takes a long time, and requires adequate skill in interpreting the results
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