| Objective: Our aim of this study is to focus that the comparison of ELISA for hepatitis C virus antibody tests between two different laboratories and to provide basis for results mutual accreditation. Methods: A total of 180 patients were recruited in the First Affiliated Hospital of Xinjiang Medical University from September 2014 to November in our study in accordance with EP12- A2 files from the CLSI. The domestic addcare ELISA 1100 was used to test HCV antibody under randomized blind method in different labs, and RIBA and PCR were also carried out to provide a evidence of true positive for HCV antibody tests. Further, we used ROC curves to identify the optimal cut-off values and compared the coincidence rate of HCV antibody tests, estimated the comparability of test results. Results: A total of 78 cases were positive, 86 cases were negative, and uncertain results of 16 cases were found in 180 samples by the gold method. The optimal S/CO threshold values, for Kehua and Wantai, were 2.44 and 5.04 by drawing ROC with the positive predictive rate of 95% or higher, positive coincidence rate of 96%, negative coincidence rate of 95% and total coincidence rate of 96%, with a non-significant difference between the two labs(P>0.05). Conclusion: Our results provide a convincing evidence that the test results has a better comparability and recognition between the two laboratories, and suggest that the weakly positive and negative samples with higher values specimens near the S/CO threshold values should be determined by the confirmed test to diagnose patients with HCV, which provides a basis of the early diagnosis and treatment. |
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