Establishment And Evaluation Of A New Strategy For Hepatitis C Laboratory Testing

Objective:Improve existing detection strategies and establish a new detection strategy for hepatitis C laboratories based on our testing population to improve the accuracy and effectiveness of test results while minimizing the cost of testing.Method:1.426 samples of positive ELISA samples were tested for CMIA,of which 294 HCV-RNA were not detected and negative samples were tested for RIBA.2.Using a non-parametric rank sum test,analyze the relationship between ELISA and CMIA to detect the S/CO values of the RIBA subgroups(negative,indeterminate,and positive).3.Use RIBA and HCV-RNA detection results as "gold standard",draw ROC curve,and discuss the best critical S/CO value as the initial screening test with ELISA and CMIA detection,and the re-exanination range that needs further confirmation.4.Analyze the correlation between ELISA test and CMIA test,and establish a new detection strategy for hepatitis C laboratories based on our laboratory test conditions and test population.5.Perform a performance evaluation of the new detection strategy.6.100 positive ELISA specimens were detected by CMIA.68 HCV-RNA non-detected and negative specimens were detected by RIBA.Verify the repeatability of the new detection strategy.Results:1.426 ELISA-positive specimens were detected by CMIA.Results:57 cases were negative and 369 cases were positive.Among the 294 RIBA test results,97 were negative,37 were indeterminate,and 160 were positive.2.Non-parametric rank sum test analysis of RIBA results S/CO ratios among subgroups,regardless of ELISA test or CMIA-test,RIBA negative group and indeterminate group S/CO values were not statistically significant(ELISA analysis P=0.142;CMIA analysis p=0.147).3.The ELISA test had the best critical S/CO value of 5.2,the retest range was 1.88-5.19,the CMIA test had the best critical S/CO value of 8.1 and the retest range was 3.35-8.09.4.Hepatitis C laboratory testing new strategy:First use ELISA test,when the S/CO value<1.88 directly reports negative,when the S/CO value ≥ 5.2 directly reports positive and recommends direct HCV-RNA testing to assess the virus status when S/CO values are used in the retest range 1.88-5.19 when using the CMIA test,when the CMIA test S/CO value<3.35 directly report negative,when the S/CO value ≥ 8.1 directly reports positive and recommended direct HCV-RNA detection The status of the virus was evaluated and further confirmed using the supplemental confirmation test(RIBA or HCV-RNA assay)when the S/CO value was located at 3.35-8.09.5.The performance evaluation of the new detection strategy:ELISA detection specificity was 91%,positive predictive value was 95.9%,CMIA detection specificity was 95.3%,positive predictive value was 97.9%,ELISA detection + CMIA detection specificity was 98.6%The positive predictive value was 99.3%.6.100 samples were tested for new detection strategies.When 5.2 was the best critical S/CO value,the sensitivity was 89.1%,the specificity was 95.6%,the positive predictive value was 96.1%,and the negative predictive value was 87.8%.CMIA detected the sensitivity of 94.5%,specificity of 97.7%,and positive predictive value of 98.1%for negative predictive value of 93.6%with 8.1 being the best critical S/CO value.The specificity of ELISA detection was 91.7%,the positive predictive value was 96%,the specificity of CMIA detection was 95.1%,the positive predictive value was 98.2%,the specificity of ELISA detection + CMIA was 98.2%,and the positive predictive value was 99%.Conclusion:A new detection strategy for hepatitis C in our laboratory and testing population has been established.It has good clinical application value.Compared with the current detection strategy;it not only improves the accuracy and effectiveness of the test results,but also effectively Saves testing costs.