Clinical Evaluation of the Newly Developed HISCL-5000 Analyzer on Detection of Hepatitis B Virus Markers in West China Hospital.

BACKGROUND

Detection of serum hepatitis B virus (HBV) markers is important for rapid screening and diagnosis of HBV infection. In this study, the newly launched HISCL-5000 analyzer (Sysmex Corporation, Kobe, Japan) was appraised in parallel with the MODULAR E170 (Roche Diagnostics, Penzberg, Germany), with regard to the detection of serological HBV markers in China for comparing and evaluating their results and capability.

METHODS

In this study, a total of 5,662 clinical serum samples were tested with the two automated systems. Among them, 1,266 samples were assessed for HBsAg, 1,000 for anti-HBs, 1,301 for HBeAg, 1,007 for anti-HBe, and 1,088 for anti-HBc. Reproducibility performance of HISCL-5000 was assayed four times per day for five days consecutively. For qualitative results between the two analyzers, the concordance rates and kappa coefficients were calculated. Spearman's rank correlation analysis was performed for quantitative results.

RESULTS

The HISCL-5000 detection mode showed excellent reproducibility with total CVs of less than 5.0%. Concordance between the two analyzers was 99.92% for HBsAg, 95.90% for anti-HBs, 100% for HBeAg, 99.30% for anti-HBe, and 98.62% for anti-HBc. Kappa values between the qualitative results of five HBV markers were 0.998, 0.906, 1.0, 0.983, and 0.969, respectively. For anti-HBs, linear regression analysis demonstrated a good correlation between HISCL-5000 and MODULAR E170 with an R2 value of 0.887. Spearman's correlation coefficients of 0.892, 0.644, -0.609, and -0.700 were observed for the other four markers, HBsAg, HBeAg, anti-H1Be, anti-HBc, respectively.

CONCLUSIONS

The newly launched HISCL-5000 displayed high agreement with the more matured MODULAR E170 on screening and diagnosing HBV infection in a clinical laboratory of West China Hospital.