化学发光法定量检测甲胎蛋白的分析性能评价

Performance evaluation for chemiluminescence immunoassay in quantitative detection of alpha-fetoprotein

目的评价化学发光法定量检测甲胎蛋白的分析性能。方法将检验标准品按照浓度不同分为6个等级,各等级的标本应用化学发光仪每天测定5次,连续5天。对检验结果的精密度、准确度及测量线性范围进行评估。结果所有6个等级每天测量值及测量总值的变异系数均小于各自的1/4总误差,精密度可靠;6个等级5天总测量均值偏倚分别为0.14%、-0.03%、0.25%、-0.37%、0.1%和-0.4%,与预示值进行线性分析,R2=0.9999,y=1.002x-0.295,与仪器提供的线性范围相一致。结论化学发光法定量检测甲胎蛋白结果准确可靠,可满足临床需要。

Objective To analyze and evaluate the performance for chemiluminescence immunoassay in quantitative detection of AFP. Methods Standard samples were divided into six grades according to their concentration. The chemiluminescence apparatus was used to detect the samples five times a day and continuous measurement for five days. Then we made an evaluation for the precision, accuracy and linear range of results. Results Both the coefficient variations of daily measurement values and total measurement values were less than a quarter of total error in each of these six grades. The bias among total meas- urement values in six grades were 0. 14% , - 0.03% , 0. 25% , - 0. 37% , 0. 1% and - 0. 4%. The result of linear analysis with the expected value is R2 = 0. 9999, y = 1. 002x-0. 295, which was in line with the linear range provided by apparatus. Conclusions The results of quantitative analysis of AFP with Chemiluminescence immunoassay is accurate and reliable, which is conformed to the requirements.