Human T-cell leukemia virus type-I/II (HTLV-I/II) serologic testing: the importance of assaying for the full complement of viral antigens.
Seventy-one Japanese adult T-cell leukemia (ATL) patients and 411 Japanese asymptomatic patients from HTLV-I endemic regions of southern Japan were found to be seropositive by radioimmunoprecipitation assay (RIPA). Of these 482 positive controls, 62% of ATL patients and 67% of the asymptomatic seropositive patients were found to harbor antibodies to p40x. Additionally, 333 preselected Japanese blood donors who were identified as seropositive by particle agglutination (PA) assay were further tested for antibodies to HTLV-I/II gene encoded envelope (env) or group specific antigens (gag) by means of enzyme-linked immunosorbent assay (ELISA) and RIPA. Concordance between ELISA and RIPA was noted in 318 samples (92.5%). Discordance between ELISA and RIPA was observed in 15 sera (7.5%)--2 were seropositive by ELISA and seronegative by RIPA and 13 were seronegative by ELISA and seropositive by RIPA. Seven of these 13 samples (53.8%) contained antibodies to p40x by RIPA and may represent ELISA false negatives on the basis of both clinical and laboratory data. Current HTLV-I/II ELISA kits may yield false negative results. Additional research into the development of rapid detection cost-efficient assays that test for the full compliment of viral antigens is needed.