2018 Volume 67 Issue 4 Pages 497-502
The screening test for human T-cell leukemia virus type 1 (HTLV-1) infection is usually performed by the detection of the HTLV-1 antibody. A new assay kit (Lumipulse HTLV-I/II FUJIREBIO) for the detection of both HTLV-1 and HTLV-2 antibodies has been developed. When we evaluated its within-precision and between-precision values, satisfactory results were obtained (the coefficient of variation was below 4%). Test results of panel sera of HTLV-1- and HTLV-2-positive samples using Lumipulse HTLV-I/II showed good agreement with the datasheet of the panel sera. Furthermore, Lumipulse HTLV-I/II showed 8- to 16-fold higher sensitivity than the current assay kit (Lumipulse HTLV-I). When 199 clinical samples from Miyazaki, Japan, an endemic area of HTLV-1, were measured using both Lumipulse HTLV-I/II and the current assay kit, two samples that tested positive with the current assay kit showed negative results with Lumipulse HTLV-I/II. These two samples tested negative by western blotting. When white blood cells from the subjects from whom these two samples were taken were tested by nested PCR, the results were negative for the HTLV-1 provirus. These results suggest that these two samples are negative for the HTLV-1 antibody. Therefore, it is considered that Lumipulse HTLV-I/II has higher sensitivity and specificity than the current assay kit.
