Comparison of four HTLV-I and HTLV-I + II ELISAs

BACKGROUND: Various countries require blood donor screening using assays applying specific HTLV-I and HTLV-II antigens. We evaluated the sensitivity and specificity of 4 anti-HTLV-I + II ELISAs (Abbott, Murex, Organon Teknika and Ortho). METHODS: Panel A consisted of HTLV-I-positive individuals (n = 41), panel B of Mixed Titer Performance Panel 204 (Boston Biomedica Inc. panels C and D of dilution series from HTLV-I-positive (n= 30) and HTLV-II-positive (n =20) individuals and panel E of sera from first-time blood donors (n = 1,055). RESULTS: In HTLV-I- and -II-positive samples, a sensitivity of 100% could be observed in all 4 ELISAs. In diluted HTLV-I- and -II-positive samples, probit analysis revealed that the Murex assay had the highest analytical sensitivity, followed by the ELISAs from Ortho, Abbott and Organon Teknika. In specimens from first-time donors, a specificity of 100% was observed in ELISAs from Murex, Organon Teknika and Ortho, and of 99.7% in the assay from Abbott. CONCLUSION: The 4 anti-HTLV-I + II ELISAs studied were appropriate as screening tests