EVALUATION OF COMMERCIAL HTLV-1 TEST KITS BY A STANDARD HTLV-1 SERUM PANEL

To evaluate the performance of currently available test kits for human T-cell lymphotropic virus type 1 (HTLV-1), we examined two particle a gglutination (PA) tests and nine enzyme immunoassays (EIA) using a sta ndard serum panel consisting of HTLV-1-positive and HTLV-1-negative se ra that had been characterized by immunofluorescence and the polymeras e chain reaction (PCR). The PA kits exhibited 94.0-100.0% sensitivity and 99.5-100.0% specificity; the sensitivity range was ascribed to the quality of the HTLV-1 antigens coated on the particles. The EIA kits had 99.5-100% sensitivity and 98.5-100% specificity; the 98.5%-99.5% s pecificity exhibited by five of the EIA kits could have been due to no nspecific reactions that were detected through use of an inadequate cu t-off value and the use of recombinant proteins. It can be concluded t hat the sensitivity of the currently available PA and EIA kits is suff icient to permit their use for screening purposes; however, the specif icity of some EIA kits should be optimized.