Screening for human immunodeficiency virus using a newly developed fourth generation lateral flow immunochromatography assay

Abstract

BackgroundHigh sensitivity for detection of HIV-1 p24 antigen allows for early detection of primary HIV-1 infections. ObjectivesTo evaluate the detection sensitivity and specificity of the Daina Screen® HIV Combo assay using clinical specimens in Japan where the pretest probability (prevalence) is low. Study designWe screened 17,373 preoperative outpatient blood samples using 4th generation lateral flow immunochromatography Daina Screen® HIV Combo assay for simultaneously detecting anti-HIV-1/2 and HIV-1 p24 antigen. ResultsOf the samples tested, 24 were positive for HIV-1 p24 antigen and 49 for HIV-1/2 antibody. Of the 49 samples, 36 were WB and HIV-1 RNA negative, 10 were WB and HIV-1 RNA positive, and 3 were WB positive, HIV-1 RNA negative, and in-house HIV-1 proviral DNA positive. RT-PCR revealed that of the 24 samples that were p24 antigen positive, one sample was HIV-1 RNA positive, which was reconfirmed using an in-house HIV-1 provirus DNA assay. From the 17,300 HIV-1 p24 antigen and anti-HIV-1/2 negative samples, pools containing 10 negative samples each were tested for HIV-1 by RT-PCR; all results were negative. ConclusionThe Daina Screen® HIV Combo assay had a sensitivity and specificity of 100% and 99.7%, respectively, which sufficiently detected HIV infection in the cohort.