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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.