Abstract
We evaluated a new fourth-generation HIV test, Lumipulse HIV Ag/Ab assay, for the measurement of the HIV antigen and antibody. Good results were obtained for the within-run precision, between-day precision and prozone phenomenon of high titers. In the detection of HIV infection using four HIV seroconversion panels, Lumipulse HIV Ag/Ab assay detected more quickly than a comparison assay using two samples. In the comparison of the sensitivities to the HIV-1 p24 antigen using WHO International Standard NIBSC, Lumipulse HIV Ag/Ab assay was observed to have a higher sensitivity than Architect・HIV Ag/Ab combo assay. However, we observed negative interference in the chyle test and a positive interference in the rheumatoid factor test. In a correlation test, two samples were unmatched between the Lumipulse HIV Ag/Ab assay and the comparison assay. In this study, although Lumipulse HIV Ag/Ab assay was good for screening HIV infection, it was necessary to judge a positive result carefully.
