四种国产乙型肝炎表面抗原定量检测试剂对弱阳性样本检测结果的一致性比较

Comparison of four domestic quantity assay reagents for detecting the weak-reactive results of HBsAg

目的比较4种国产HBsAg定量检测试剂与ARCHITECTi2000免疫检测系统对HBsAg弱阳性样本检测结果的一致性及检测值之间的相关性。方法采用4种国产发光法检测系统和i2000检测系统分别检测185例HBsAg弱阳性血清标本以及不同浓度HBsAg的标准品。应用描述性统计和相关分析计算不同试剂分析结果的精密度、一致性和相关性。结果4种国产发光法检测系统对i2000检测系统定量为0．05～1．00IU／ml的弱阳性结果判断的符合率分别为25．93％、35．19％、51．85％和18．52%；对定量为〉1．00～10．00IU／ml的弱阳性结果判断的符合率分别为71．76％、87．79％、95．42％和69．47％。4种国产试剂均检测阴性的标本为i2000检测值在0．05～0．80IU／ml的低值阳性标本；i2000检测结果≥7．93Iu／ml的样本，4种国产发光法检测系统符合率为100％。国产试剂检测结果之间的相关性分析结果显示，其相关系数为0．8629～0．9265。结论国产检测系统的分析灵敏度略低于i2000检测系统，检测值≤0．80IU／ml的样本不能给出与i2000一致的检测结果；对于≥7．93IU／ml的样本，国产试剂均可给出与i2000一致的结果。

Objective To evalue the coincidence and correlation between the four domestic quantity assay reagents and with ARCHITECTi2000 immunoassay system. Methods 185 weak-reactive serum samples and standard materials of different concentrations were tested by four domestic quantity assay reagents for HBsAg test and ARCHITECTi2000 immunoassay system. The coincidence, the precision and the correlations between different systems were analyzed. Results The coincidence rates of the results of 0.05-1.00 IU/ml samples between the four domestic quantity assay reagents and ARCHITECTi2000 immunoassay system were 25.93%, 35.19%, 51.85% and 18.52% respectively, and for those results of 〉 1.00-10.00 IU/ml samples the coincidence rates were 71.76%, 87.79%, 95.42% and 69.47% respectively. The samples of 0.05-0.801U/ml weak-reactive serum samples detected by the i2000 system were all negative detected by the four domestic systems. The coincidence rates of 〉 7.93 IU/ml serum samples detected by i2000 system were 100% detected by the four domestic systems. The correlations of the four domestic quantity assays were around 0.8629-0.9265. Conclusions The analysis sensitivity of the four domestic quantity assay reagents were below the i2000 system. The results of under 0.80 IU/ml samples detected by i2000 system were disaccord with the results detected by the four domestic systems, whereas for the sapmples over 7.93 IU/ml the results were consistent.