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Predictive Value of Screening Tests for Persistent Hepatitis C Virus Infection Evidenced by Viraemia: Japanese Experience
Authors:J Watanabe  C Matsumoto  K Fujimura  T Shimada  K Nishioka  H Yoshizawa  H Okamoto  H Iizuka  T Tango  H Ikeda  N Endo  T Mazda  T Nojiri  K Aoyama  K Kanemitsu  H Yamano  M Mizui  F Yokoishi  K Tokunaga
Abstract:In November 1989, Japanese Red Cross Blood Centres started screening for heaptitis C virus (HCV) with enzyme-linked immunosorbent assay (Elisa) for the C100-3 viral peptide as the first such nationwide programme in the world. Thereafter post-transfusion non-A non-B hepatitis (PTNANBH) was reduced by 61–80%, but this was not as complete a success as our programme to prevent post-transfusion hepatitis B by screening for high titer hepatitis B core antibody, which we began in the same period. In order to acquire more effective control of PTNANBH, the HCV core-related antigen (GOR, N14) and second-generation Elisa (Ortho2, Abbott2)and second-generation antigen agglutination (PA, PHA) tests have been employed. Among 16,500 donors in 11 blood centers, 365 were serologically positive by at least one of these tests. Among these, HCV RNA was detected in 138 units and the remaining 227 were HCV RNA negatives. The effectiveness of these serological tests to detect HCV RNA-positive status were analyzed. Passive haemagglutination and particle agglutination (PHA and PA) tests were highly effective to predict HCV viraemia among blood donors. Also, these tests can easily determine antibody titre. By either PHA or PA, all units with ≧212 agglutination titre (120 and 122 units) were HCV RNA positive and all agglutination-positive units with serum alanine aminotransferase level higher than 35 Karmen units were HCV RNA positive. These results have formed the basis for implementing a more effective screening for HCV viraemia in blood donors, where effectiveness is defined as enhancing the protection of patients from post-transfusion hepatitis C and providing higher quality information to achieve more effective donor counselling.
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