酶联免疫吸附试验检测乙型肝炎病毒血清学标志物的性能评价

Performance evaluation of ELISA for detecting HBV serological markers

目的通过检测乙型肝炎病毒（HBV）血清学标志物,对ADDCAER1100全自动酶免工作站进行定性试验的性能评价。方法根据美国临床实验室标准化协会（NCCLS）颁布的EP12-A文件,以Architect I2000全自动化学发光免疫分析仪（简称Architect I2000）为参考方法,对ADDCAER1100全自动酶免工作站（简称ADDCAER1100）进行HBV血清学标志物检测的方法学对比及重复性试验,完成其定性试验的性能评价。结果方法学比较显示,HBsAg、HBsAb、HBeAg、HBeAb、HBcAb的总符合率分别为99.0%、99.5%、99.5%、98.0%、100.0%;阳性符合率分别为98.0%、100.0%、99.0%、97.0%、100.0%,阴性符合率分别为100.0%、99.0%、100.0%、99.0%、100.0%,Kappa系数分别为0.98、0.99、0.99、0.96,1.00。重复性试验显示,HBsAg、HBsAb、HBeAg、HBeAb、HBcAb±20%浓度的临界值样本阳（阴）性率均不小于95%,95%置信区间分别为：96.6%-99.5%、97.6%-99.5%、97.6%-99.5%、94.7%-99.5%、98.6%-99.5%。结论 ADDCAER1100与Architect I2000检测HBV血清学标志物的结果一致性较强,ADDCAER1100检测HBV血清学标志物在临界值±20%的浓度内能得到稳定结果。该仪器的性能可靠,可用于标本的检测。

Objective To conduct the performance evaluation of the qualitative tests in the ADDCAER ELISA1100 automated workstation by detecting the hepatitis B virus（HBV）serological markers.Methods According to EP12-A document promulgated by the National Committee for Clinical Laboratory（NCCLS）,with the Architect I2000 automatic chemiluminescence immunoassay analyzer as the reference method,the methodological comparison and the repeatability test of the HBV serological markers detection by the ADDCARE ELISA automated workstation were performed for completing its qualitative test performance evaluation.Results The methodological comparison showed that of the total coincidence rate of HBsAg,HBsAb,HBeAg,HBeAb and HBcAb were 99.0%,99.5%,99.5%,98.0% and 100.0%,respectively;the positive coincidence rates were 98.0%,100.0%,99.0%,97.0% and100.0%,respectively;the negative coincidence rate were 100.0%,99.0%,100.0%,99.0% and 100.0%,respectively;the Kappa values were 0.98,0.99,0.99,0.96 and 1.00 respectively.The repeatability tests showed that the positive（negative）rates of critical value in HBsAg,HBsAb,HBeAg,HBeAb and HBcAb within±20%concentration≥95%,the 95% confidence intervals were 96.6%-99.5%,97.6%-99.5%,97.6%-99.5%,94.7%-99.5% and98.6%-99.5%,respectively.Conclusion The results of the ADDCAER ELISA 1100 automated workstation and the Architect I2000 automatic chemiluminescence immunoassay analyzer for detecting the HBV serological markers have strong consistency.The ADDCAER ELISA 1100 automated workstation for detect HBV serological markers obtains the stable results within ± 20% concentration near cutoff points and is reliable in performance,thus can be used to qualitatively detect HBV serological markers in clinical specimens.