BACKGROUND: The hepatitis C virus antibody (anti-HCV) can be identified with third-generation immunoassays. The purpose of this study was to define the correlation or agreement between first and second reactive results of anti-HCV microparticle-based enzyme immunoassay (MEIA) and of chemiluminescence assays (ChLIAs) in blood donors, to determine whether repeat testing is necessary. STUDY DESIGN AND METHODS: Commercially available assays, third-generation HCV MEIA (Abbott), third-generation HCV ChLIA (Ortho), and third-generation HCV ChLIA (Abbott), were used to evaluate anti-HCV repeatedly reactive blood obtained from donations made at 23 Mexican blood centers over a period of 1 year. The intraassay correlation between first and second reactive anti-HCV tests with the Pearson r test and the coefficient of variation (CV) were determined. RESULTS: The intraassay correlation of 565 anti-HCV repeatedly reactive samples was 0.996 for the Abbott third-generation HCV MEIA, 0.995 for the Ortho third-generation HCV ChLIA, and 0.993 for the Abbott third-generation HCV ChLIA. The CVs of these assay systems were 2.82, 5.33, and 5.69 percent, respectively. CONCLUSION: A highly significant intraassay correlation between anti-HCV duplicates was found. Specimens with a single reactive anti-HCV result with the Abbott third-generation HCV MEIA, Ortho third-generation HCV ChLIA, and Abbott third-generation HCV ChLIA assays should be considered as positive and need not be retested. Such a change in the algorithm for blood donor screening is feasible because of the availability of highly automated platforms.
BACKGROUND: The hepatitis C virus antibody (anti-HCV) can be identified with third-generation immunoassays. The purpose of this study was to define the correlation or agreement between first and second reactive results of anti-HCV microparticle-based enzyme immunoassay (MEIA) and of chemiluminescence assays (ChLIAs) in blood donors, to determine whether repeat testing is necessary. STUDY DESIGN AND METHODS: Commercially available assays, third-generation HCV MEIA (Abbott), third-generation HCV ChLIA (Ortho), and third-generation HCV ChLIA (Abbott), were used to evaluate anti-HCV repeatedly reactive blood obtained from donations made at 23 Mexican blood centers over a period of 1 year. The intraassay correlation between first and second reactive anti-HCV tests with the Pearson r test and the coefficient of variation (CV) were determined. RESULTS: The intraassay correlation of 565 anti-HCV repeatedly reactive samples was 0.996 for the Abbott third-generation HCV MEIA, 0.995 for the Ortho third-generation HCV ChLIA, and 0.993 for the Abbott third-generation HCV ChLIA. The CVs of these assay systems were 2.82, 5.33, and 5.69 percent, respectively. CONCLUSION: A highly significant intraassay correlation between anti-HCV duplicates was found. Specimens with a single reactive anti-HCV result with the Abbott third-generation HCV MEIA, Ortho third-generation HCV ChLIA, and Abbott third-generation HCV ChLIA assays should be considered as positive and need not be retested. Such a change in the algorithm for blood donor screening is feasible because of the availability of highly automated platforms.