科华ELISA与雅培i2000sr检测系统对4种感染性疾病8项血清标志物检测的性能评价

Performance Evaluation of Kehua ELISA and Abbott i2000sr in Eight Serum Markers Detection for Four Infectious Diseases

目的对科华ELISA和雅培i2000sr检测系统4种感染性疾病8项血清学标志物的性能进行评价和比较。方法采用美国临床和实验室标准协会(clinical and laboratory standards institute,CLSI)评价方案(evaluation protocols,EP)评价两种检测系统性能。评价内容包括:准确度、检出限、一致性、精密度、线性范围。结果两种检测系统的准确度均为100%。HBsAg,HBsAb,HBeAg,HBeAb,HBcAb,Anti-HCV,梅毒特异性抗体及(Anti-TP)Anti-HIV的检出限科华分别为0.08IU/ml,10mIU/ml,0.8NCU/ml,4.4NCU/ml,3.2NCU/ml,0.8NCU/ml,20mIU/ml和0.5NCU/ml;雅培分别为0.05IU/ml,10mIU/ml,0.23NCU/ml,1NCU/ml,1.8NCU/ml,0.45NCU/ml,20mIU/ml和2.88NCU/ml。一致性验证:两种系统方法学比对Kappa值分布于0.8～0.9,定性项目仪器间比对Kappa值均为1,定量项目(HBsAg,HBsAb)仪器间比对观察误差<1/2TEa,浓度误差指数绝对值<1。精密度评价:批内变异系数(CV)范围为1.10%～7.01%,室内CV范围为1.90%～10.03%。雅培i2000sr HBsAg,HBsAb线性范围分别为0.73～245IU/ml和4.21～960.89mIU/ml。结论科华ELISA和雅培i2000sr准确度、检出限、一致性、精密度和线性范围与厂家声明一致并能满足实验室要求。两种系统HBsAg,HBsAb,Anti-TP检出限接近,但HBeAg,HBeAb,HBcAb,Anti-HCV和Anti-HIV检出限二者存在较大差异。

Objective The present study was carried out to evaluate the performance of Kehua ELISA and Abbott i2000 sr for eight serum markers detection.Methods The performances,i.e.,accuracy,limit of detection(LOD),consistency,precision and linear range were evaluated according with the CLSI EP documents.Results The accuracy of the two systems were100%.The LOD of HBsAg,HBsAb,HBeAg,HBeAb,HBcAb,Anti-HCV,Anti-TP and Anti-HIV were 0.08 IU/ml,10 mIU/ml,0.8 NCU/ml,4.4 NCU/ml,3.2 NCU/ml,0.8 NCU/ml,20 mIU/ml and 0.5 NCU/ml for Kehua,and 0.05 IU/ml,10 mIU/ml,0.23 NCU/ml,1 NCU/ml,1.8 NCU/ml,0.45 NCU/ml,20 mIU/ml and 2.88 NCU/ml for Abbott,respectively.The consistency test showed that the Kappa value was 0.8 to 0.9 for method comparison and 1 for instruments comparison.Multiple instruments comparison for HBsAg and HBsAb,the observed error was<1/2 TEa and error index by concentration was<1.The coefficients of variations(CV)of within-run and laboratory precision were 1.10% ～7.01% and 1.90～10.03%,respectively.The linear ranges of HBsAg and HBsAb were 0.73～245 IU/ml and 4.21～960.89 mIU/ml,respectively.Conclusion The performances of two systems,such as LOD,consistency,precision and linear range,were consistent with manufacturer’s declaration and met the clinical requirements.Kehua was close to i2000 sr on the detection ability of HBsAg,HBsAb and Anti-TP,however,obvious difference in the detection ability of HBeAg,HBeAb,HBcAb,Anti-HCV and anti-HIV was observed between two systems.