PERFORMANCE OF 3 GENERATIONS OF ANTI-HEPATITIS-C VIRUS ENZYME-LINKED IMMUNOSORBENT ASSAYS IN DONORS AND PATIENTS

BACKGROUND: Prevention of posttransfusion non-A,non-B hepatitis in rec ipients of blood components improved considerably with the introductio n of the second-generation of hepatitis C virus (HCV) antibody tests. In 1993, third-generation HCV antibody assays were introduced in Europ e. STUDY DESIGN AND METHODS: The performance of three generations of a nti-HCV enzyme-linked immunosorbent assay (ELISA) (ELISA-1, -2, -3) wa s compared in routine blood donor screening (99,394 donations were tes ted with ELISA-1, 167,999 donations with ELISA-2, and 262,090 donation s with ELISA-3) and in serial samples from nine patients with document ed acute posttransfusion HCV infection. RESULTS: Eight (0.01%) repeat donors, previously negative in ELISA-1, were found positive in ELISA-2 and were confirmed as positive in second-generation recombinant immun oblot assay and/or cDNA polymerase chain reaction. In the donor popula tion, no difference in the sensitivity of ELISA-2 and -3 was observed. The specificity of the three generations of ELISAs was comparable (99 .8, 99.7, and 99.7%). In seroconversion samples, ELISA-2 and -3 detect ed HCV antibodies at the same time in seven patients, but in two patie nts, ELISA-3 found HCV antibodies, respectively, 63 and 77 days earlie r than ELISA-2 did. In the seroconversion samples, ELISA-2 and -3 were significantly more sensitive than second-and third-generation recombi nant immunoblot assays. CONCLUSION: ELISA-3 did not detect more HCV-in fected individuals in a donor population that previously tested negati ve in ELISA-2, but it did detect HCV antibodies earlier in some patien ts with acute HCV infection. ELISA-2 and -3 were significantly more se nsitive than second-and third-generation recombinant immunoblot assays .