Comparison of the results for three automated immunoassay systems in determining serum HBV markers.

摘要

BACKGROUND: Automated immunoassay analyzers are used to identify hepatitis B virus (HBV) serum markers. In regions with high prevalence of HBV, it is imperative to compare test results from different immunoassay analyzers. METHODS: Samples from 496 subjects were collected and HBV markers were determined (double-blind, parallel manner) using Abbott AxSYM, Roche Modular Analytics E170, and Abbott Architect i2000). RESULTS: Concurrence between AxSYM and E170 was 97.78% for HBsAg, 91.13% for anti-HBs, 98.79% for anti-HBc, 98.39% for HBeAg, and 88.91% for anti-HBe. Positive rates of anti-HBs and anti-HBe from AxSYM were lower than E170 (P<0.01). Concurrence between AxSYM and Architect i2000 was 98.79% for HBsAg, 91.33% for anti-HBs, 95.97% for anti-HBc, 98.39% for HBeAg, and 95.77% for anti-HBe. Positive anti-HBs rates from AxSYM were lower than Architect i2000 (P<0.01). Concurrence between E170 and Architect i2000 was 97.38% for HBsAg, 94.15% for anti-HBs, 95.56% for anti-HBc, 99.60% for HBeAg, and 88.10% for anti-HBe. Positive anti-HBe rates using Architect i2000 were lower than E170 (P<0.01). Overall, the greatest differences were observed in samples with low-level serum HBV markers. CONCLUSION: Significant discrepancies were observed among results for the 3 automated immunoassay analyzers, especially for low-level anti-HBs and anti-HBe results.