Feng Shu, Wei Bin, Rao Chenli, Wang Tingting, Xiao Yuling, Tao Chuanmin, Wang Lanlan
Clin Lab. 2016;62(6):1053-60. doi: 10.7754/clin.lab.2015.150943.
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.
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.
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.
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.
血清乙肝病毒（HBV）标志物检测对于HBV感染的快速筛查和诊断至关重要。在本研究中，对新推出的HISCL - 5000分析仪（日本神户Sysmex公司）与MODULAR E170（德国彭茨贝格罗氏诊断公司）进行了平行评估，以检测中国血清学HBV标志物，比较并评估它们的结果和性能。
本研究中，使用这两种自动化系统对总共5662份临床血清样本进行了检测。其中，1266份样本检测HBsAg，1000份检测抗 - HBs，1301份检测HBeAg，1007份检测抗 - HBe，1088份检测抗 - HBc。连续五天每天对HISCL - 5000的重复性性能进行四次检测。对于两种分析仪的定性结果，计算一致性率和kappa系数。对定量结果进行Spearman等级相关分析。
HISCL - 5000检测模式显示出优异的重复性，总变异系数小于5.0%。两种分析仪之间HBsAg的一致性为99.92%，抗 - HBs为95.90%，HBeAg为100%，抗 - HBe为99.30%，抗 - HBc为98.62%。五种HBV标志物定性结果之间的kappa值分别为0.998、0.906、1.0、0.983和0.969。对于抗 - HBs，线性回归分析表明HISCL - 5000与MODULAR E170之间具有良好的相关性，R²值为0.887。对于其他四种标志物HBsAg、HBeAg、抗 - HBe、抗 - HBc，Spearman相关系数分别为0.892、0.644、 - 0.609和 - 0.700。
在华西医院临床实验室中，新推出的HISCL - 5000在筛查和诊断HBV感染方面与更成熟的MODULAR E170显示出高度一致性。
