Objective: To determine the epidemiologic, clinical, serologic, and histologic importance of antibodies to hepatitis C virus (anti‐HCV) in blood donors. Design: Cross‐sectional identification and prospective evaluation of seropositive donors; retrospective assessment of infectivity; and nested casecontrol study for risk factors. Setting: Liver unit of a referral‐based university hospital. Subjects: Of 30 231 consecutive donors, 368 (1.2%) were found to be anti‐HCV‐reactive by enzyme‐linked immunosorbent assay (ELISA). Two hundred and fifty‐four of these 368 donors were evaluated for risk factors by comparison with 284 age‐ and sex‐matched controls. Eighty‐six spouses of seropositive donors were also evaluated. Measurements and Main Results: Twenty‐four percent of the seropositive donors had a history of percutaneous exposure to blood. This rate increased to 45% when only those donors confirmed to be anti‐HCV positive by a second‐generation recombinant immunoblot assay (RIBA‐2) were considered. A family history of liver disease (odds ratio, 2.8; 95% CI, 1.6 to 4.8), previous blood transfusion (odds ratio, 6.1; 95% CI, 3 to 12.5), and a history of tattooing or intravenous drug abuse (odds ratio, 8.4; 95% CI, 2.3 to 31) were associated with anti‐HCV seropositivity. An elevated alanine aminotransferase (ALT) level was found in 58% of the seropositive donors. Of the 150 donors tested, 104 (69%; CI, 62% to 77%) were confirmed by RIBA‐2 to be anti‐HCV positive. Of the 105 donors who had a biopsy, 16% had normal histologic findings, 11% had minimal changes, 21% had chronic persistent hepatitis, 45% had chronic active hepatitis, and 7% had active cirrhosis. All 77 donors with RIBA‐2‐confirmed seropositivity had histologic abnormalities. Of 43 donors evaluated in an infectivity study, 82% were implicated in previous HCV transmission. Only 2.3% of the spouses were anti‐HCV positive. The ELISA, RIBA‐2, and ALT results correlated with infectivity and abnormal histologic findings. Conclusions: In our geographic area, almost 70% of donors who are anti‐HCV positive by ELISA are confirmed to be positive by RIBA‐2; most of these donors appear to be chronic carriers of HCV and have substantial liver disease.
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