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Predictive value of screening tests for persistent hepatitis C virus infection evidenced by viraemia. Japanese
J Watanabe1, C Matsumoto, K Fujimura
1Japanese Red Cross Central Blood Center, Tokyo, Japan.
Insights
Japanese blood centers improved hepatitis C virus (HCV) screening with new tests, significantly reducing post-transfusion non-A non-B hepatitis. Passive haemagglutination and particle agglutination tests effectively identified HCV viraemia in donors.
Area of Science:
- Transfusion Medicine
- Virology
- Immunology
Background:
- Hepatitis C virus (HCV) screening began in Japan in 1989 using enzyme-linked immunosorbent assay (Elisa) for the C100-3 peptide.
- Initial screening reduced post-transfusion non-A non-B hepatitis (PTNANBH) by 61-80%, but less effectively than hepatitis B screening.
- Further improvements were sought for PTNANBH control.
Purpose of the Study:
- To evaluate the effectiveness of new serological tests for detecting HCV RNA in blood donors.
- To assess the utility of HCV core-related antigen (GOR, N14), second-generation Elisa (Ortho2, Abbott2), and second-generation agglutination tests (PA, PHA).
Main Methods:
- Screening of 16,500 donors across 11 blood centers.
- Utilized enzyme-linked immunosorbent assay (Elisa), HCV core-related antigen (GOR, N14), and second-generation tests (Ortho2, Abbott2, PA, PHA).
- HCV RNA detection was performed on serologically positive samples.
Main Results:
- 365 out of 16,500 donors were serologically positive.
- HCV RNA was detected in 138 units; 227 were HCV RNA negative.
- Passive haemagglutination (PHA) and particle agglutination (PA) tests were highly effective in predicting HCV viraemia.
- All units with PHA/PA titre ≥ 2(12) and those with elevated alanine aminotransferase were HCV RNA positive.
Conclusions:
- Passive haemagglutination (PHA) and particle agglutination (PA) tests are highly effective for predicting HCV viraemia in blood donors.
- These agglutination tests can easily determine antibody titre.
- PHA and PA tests, especially with specific titres or combined with ALT levels, accurately identify HCV RNA-positive units.
Abstract:
In November 1989, Japanese Red Cross Blood Centres started screening for hepatitis 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 > or = 2(12) 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.(ABSTRACT TRUNCATED AT 250 WORDS)