[Evaluation of the test results on hepatitis B pilot surveillance labortory in 9 provinces of China].

Abstract

Objective: To assess the test quality of HBsAg, anti-HBc IgM and anti-HAV IgM in the laboratories of Hepatitis B pilot surveillance provinces.

Methods: Blood serum from each of the Hepatitis B pilot surveillance provinces were collected to verify the test results. The Chemiluminescence Microparticle Immuno Assay (CMIA), ARCHITECT i2000 automatic light detector and test reagents produced by U.S.A. Abbott corporation were used in the retest. Using the Abbott reagent CMIA test results as the criteria, the domestic made ELISA reagents sensitivity, specificity, the total coincidence rate and Yoden index of HBsAg, anti-HBc IgM and anti-HAV IgM were evaluated in Hepatitis B pilot surveillance provinces.

Results: In the National Notifiable Diseases Reporting System (NNDRS) reported Hepatitis B cases, the proportion of detecting HBsAg and anti-HBc IgM was 98.53% and 39.49% respectively. Through the verification test to the reported cases in Hepatitis B pilot surveillance provinces, the original and veritication diagnosis 01 the reported eases was quite different. Among 197 acute Hepatitis B reported cases, 56 cases were agreeable with diagnosis cretirea, accounting for 28.42%. Among 1046 chronic Hepatitis B reported cases, the verification diagnosis of 602 cases was consistent with the original diagnosis, accounting for 57.55%. By using Abbott reagent and CMIA method to test again, it was found that the verification test results using domesticmade reagent and ELISA assay were low consistency compared with the test results of Abbott reagent CMIA method. The detection result of home-made reagents by ELISA compared with the Abbott reagents CMIA, the sensitivity and the total coincidence rate of HBsAg were over 95%, Kappa value was 0.439, and specificity was only 50.00%. The sensitivity, the total coincidence rate and the specificity of Anti-HBc IgM were moderate level, Kappa value was 0.516. The sensitivity of Anti-HAV IgM were 20%, and the total coincidence and specificity were higher, Kappa value was 0.033, the consistency of test was poor.

Conclusion: It's necessary to improve the detection ability of Hepatitis B etiology of indicators in order to improve the accuracy of the report of Hepatitis B cases.