Seroprevalence of known and putative hepatitis markers in United States blood donors with ALT levels at least 120 IU per L

BACKGROUND: ALT testing of blood donors was initiated as a surrogate marker for non-A, non-B hepatitis. Increased sensitivity of subsequent HBV and HC V tests used for standard donor screening make any residual value of ALT te sting questionable. STUDY DESIGN AND METHODS: A prospective study was conducted in 166 of 645 e ligible blood donors from three American Red Cross regions whose ALT was gr eater than or equal to 120 IU per L and whose standard donor screening test s were negative. Of these enrolled donors, 124 (75%) completed follow-up. S amples obtained from the index donation, at enrollment (1 month), and at fo llow-up (6 months) underwent the standard donor screening tests, as well as those for HCV RNA and HGV RNA (RT-PCR), antibodies to the virus envelope E 2 protein of GB virus type C (GBV-C E2 antibody), and IgM antibody for CMV, parvovirus B19, EBV VCA, and HAV. Participants completed a brief demograph ic and exposure history questionnaire at follow-up. RESULTS: All study samples were negative in standard donor-screening tests. ALT levels were variable at return visits, with 80 to 86 percent < 120 IU per L. No participants were positive for HCV RNA; 4 percent were positive f or HGV RNA, and 16 percent were positive for GBV-C E2 antibody. Results of CMV, parvovirus B19, EBV VCA, and HAV testing were similar to published bac kground rates. No demographic or exposure history variables had significant correlation with ALT or other testing results. CONCLUSION: These data suggest that an ALT greater than or equal to 120 IU per L in blood donors with negative standard screening tests has questionab le value as a surrogate marker for seronegative HBV or HCV infection. Conti nued ALT testing may contribute little, if anything, to the safety of blood components or plasma for further manufacture.