Evaluation of a combined lysate/recombinant antigen anti‐HTLV‐I/II ELISA in high and low endemic areas of HTLV‐I/II infection

SUMMARY. The Wellcozyme HTLV‐I/II ELISA (Murex Diagnostics) was evaluated in 7800 samples of various serum panels. Repeat reactivity was found by Wellcozyme in (A) 1/2181 (0.05%) Dutch blood donors, (B) 44/3036 (1.4%) Curaçao (Caribbean area) blood donors, (C) 46/2533 (1.8%) individuals of different Ethiopian population subsets, (D) 30/30 (100%) confirmed anti‐HTLV‐I positive samples and (E) 20/20 (100%) HTLV‐II PCR‐positive samples. All 91 Wellcozyme‐positive samples were tested for confirmation by Western blot (WB, Diagnostic Biotechnology). Among Wellcozyme HTLV‐I/II ELISA‐positive individuals, HTLV‐I/II WB positivity was found in 0/1 Dutch blood donors, 40/44 (88.9%) Curaçao blood donors and 20/46 (43.5%) Ethiopian individuals. HTLV‐I positivity was found in 40 (1.3%) WB‐positive Curaçao blood donors and in 9 (0.35%) Ethiopian individuals. HTLV‐II positivity was found in 11 (0.43%) WB‐positive Ethiopian individuals. The Wellcozyme HTLV‐I/II ELISA had a specificity of 99.95% in Dutch blood donors and a sensitivity of 100% in confirmed HTLV‐I‐ and HTLV‐II‐positive samples. In Ethiopia 55% of the HTLV‐I/II WB‐positive individuals were exclusively HTLV‐II positive, whereas in Curaçao no HTLV‐II infections were found. Copyright © 1995, Wiley Blackwell. All rights reserved