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Comparative assay of Hepatitis B and C virus infection markers by different assay kits
1Department of Food and Nutrition, Kyoto Women's University, Kyoto 605-8501, Japan.
Insights
Enzyme immunoassay (EIA) and radioimmunoassay (RIA) kits showed varying sensitivity for detecting hepatitis B virus (HBV) and hepatitis C virus (HCV) infection markers. Laboratory A
Area of Science:
- * Virology and Immunology
- * Infectious Disease Epidemiology
- * Diagnostic Assay Development
Background:
- * Hepatitis B virus (HBV) and hepatitis C virus (HCV) are significant global health concerns.
- * Accurate diagnostic assays are crucial for epidemiological surveillance and patient management.
- * Enzyme immunoassay (EIA) and radioimmunoassay (RIA) are common methods for detecting viral infection markers.
Purpose of the Study:
- * To compare the sensitivity of EIA and RIA assay kits for HBV and HCV infection markers.
- * To evaluate the performance of different kits (Chinese vs. international) for HCV detection.
- * To assess the epidemiological implications of assay sensitivity variations in northeast China.
Main Methods:
- * Collection of 100 serum samples from adult women in urban and rural northeast China.
- * Testing for HBV markers (HBsAg, anti-HBs, anti-HBc) and HCV marker (anti-HCV) using EIA and RIA kits in two laboratories.
- * Comparison of results from Laboratory A (Chinese EIA kits) and Laboratory B (RIA kits).
Main Results:
- * Laboratory A (EIA) detected 2 HBsAg+ cases, while Laboratory B (RIA) detected 9 HBsAg+ cases.
- * Laboratory A (EIA) detected 19 anti-HCV+ cases, while Laboratory B (RIA) detected 3 anti-HCV+ cases.
- * Agreement between testing methods varied, with highest agreement for HBsAg (93%) and lowest for anti-HCV (82%).
Conclusions:
- * Significant differences in sensitivity were observed between EIA and RIA kits for HBsAg and anti-HCV detection.
- * The origin of EIA kits (China vs. international) impacted HCV detection rates.
- * Assay choice can influence the estimated prevalence of HBV and HCV infections, impacting epidemiological assessments.
Abstract:
In order to compare sensitivity of EIA and RIA assay kits for hepatitis B and C virus (HBV and HCV, respectively) infection markers, 100 serum samples in total were collected form 50 adult women each in urban and rural areas in northeast China. The number of positive cases to the three infection markers on HBV (i.e., HBsAg+, anti-HBs+, and anti-HBc+) and the one on HCV (anti-HCV+) were examined in two laboratories, i.e., in Laboratory A with EIA kits produced in China and in Laboratory B with RIA kits. HCV infection positivity (anti-HCV+) was examined by EIA kits in both laboratories, but from different sources in and outside of China, respectively. The assay in Laboratory A gave 2 HBsAg+ cases out of the 100 cases examined, whereas there were 9 positive cases in Laboratory B. In contrast, 19 cases were positive to anti-HCV when examined in Laboratory A, and there were 3 cases in Laboratory B. Thus, the kits used in Laboratory A gave fewer HBsAg+ and more anti-HCV+ cases than the kits used in Laboratory B. The prevalence of anti-HBs+ or anti-HBc+ and cases did not differ when assayed in the two laboratories with EIA and RIA kits, respectively. The agreement of positive and negative findings between the two sets of testing were 93%, 93%, 93%, 86% and 82% for HBsAg, anti-HBs, anti-HBc, HBV (i.e., either positive to anyone of the three markers or negative to all three markers), and anti-HCV, respectively. The implication of the observation on epidemiology on HBV and HCV infection prevalence was discussed.