Human T-cell leukemia virus type I (HTLV-1) is estimated to have infected 15-20 million worldwide, and over 1 million in Japan. HTLV-1 is well-known as the cause of several severe diseases, such as adult T-cell leukemia and HTLV-1-associated myelopathy/tropical spastic paraparesis. A screening test for the antibody to HTLV-1 was implemented to test all donated blood samples in the Japanese Red Cross Blood Center in 1986. The examination is carried out using chemiluminescence enzyme immunoassay (CLEIA). Western blotting (WB), instead of indirect immunofluorescence assay (IF), has been adopted as a confirmatory process following CLEIA since September 2012. However, numerous cases have been deferred in which serum samples, positive on CLEIA, displayed indeterminate patterns on subsequent WB. To clarify the specificity of these WB indeterminate patterns, 239 serum samples deferred on WB were examined using particle agglutination assay, chemiluminescence immunoassay (CLIA), IF, line immunoassay, and PCR for HTLV-1 provirus detection, with findings for the differences in reactivity for antibody tests compared on the basis of the kinds and origins of immobilized antigens in each examination. Results from PCR showed that 89 (37.2%) of the 239 deferred samples in WB were positive for HTLV-1 provirus. In contrast, specific antibodies were detected in 19 (12.7%) of 150 PCR-negative cases. While 83 (93.3%) were positive for all antibody tests, anti-Gag antibody was predominantly observed in only 2 (2.2%) of 89. Only anti-Env antibody was detected in 1 (1.1%) case, which was positive only on CLIA. These findings indicate that genuine HTLV-1 carriers are included among individuals with indeterminate patterns on WB and suggest the existence of occult HTLV-1 carriers, indicating a much higher incidence of HTLV-1 in Japan than previously reported.
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