Evidence that use of a second‐generation hepatitis C antibody assay prevents additional cases of transfusion‐transmitted hepatitis

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Abstract
SUMMARY. The aim of this study was to determine if using hepatitis C antibody (anti‐HCV) enzyme immunoassay version 2.0 (EIA2) in addition to version 1.0 (EIA1) increased the safety of the blood supply. Blood non‐reactive by anti‐HCV EIA1 was transfused in 1990‐92. Stored samples from 40098 units, donated prior to 13 March 1992 were later tested by EIA2. For donor units reactive for anti‐HCV by EIA2. a recombinant immunoblot assay (RIBA2) was also carried out. In 63 cases, recipients of transfusions which were EIAZ negative or EIA2 reactive were tested for anti‐HCV and elevated alanine aminotransferase (ALT) levels 9‐1 2 months after transfusion: pretransfusion anti‐HCV status of recipients was unknown. Among these multitransfused patients receiving units that were negative by both EIA1 and EIA2, 1/26 (4%) had anti‐HCV. Among transfusion recipients of units negative by EIA1, but who received at least one unit reactive by EIA2,4/37 recipients (11%) were anti‐HCV reactive (P = 0.59). For the recipients of EIA2 reactive blood, when the donor unit was RIBA2 non‐reactive. 0/23 recipients were reactive by anti‐HCV. Among the recipients of a RIBA2 indeterminate unit, 1/10 recipients had anti‐HCV, but for patients who received at least one RIBA2 reactive unit, 3/4 recipients had anti‐HCV (P = 0.0 3). Hence. second‐generation anti‐HCV testing detected additional units capable of transmitting hepatitis C that were not detected by first‐generation testing. However, RIBA2 is a more specific method than EM2 for determining units capable of transmitting HCV.