肠道病毒EV71型和CA16型IgM抗体检测试剂盒的分析性能

Analytical performance of enterovirus EV71 and CA16 IgM antibody detection kits

目的 评价基于磁微粒化学发光法的肠道病毒71型(EV71)和柯萨奇病毒A16型(CA16)IgM抗体检测试剂盒的精密度、稳定性及方法学比对,并初步评价其临床应用价值。方法 参照美国临床实验室标准化协会(CLSI)相关文件和标准,对柯萨奇病毒A16型IgM抗体检测试剂盒(磁微粒化学发光法)(CA16 IgM CMIA)和肠道病毒71型IgM抗体检测试剂盒(磁微粒化学发光法)(EV71 IgM CMIA)进行分析性能评价。采用受试者工作特征曲线评估CA16 IgM CMIA及EV71 IgM CMIA与已上市酶联免疫法检测试剂的符合率。结果 CA16 IgM CMIA批内精密度CV为1.10%和1.63%,中间精密度CV为5.70%~7.20%,EV71 IgM CMIA批内精密度CV为2.80%和1.59%,中间精密度CV为2.91%~4.49%,试剂机载稳定性良好。临床病症与手足口病相似或病原结构与肠道病毒相近的其他病原体的高浓度抗体特异性血清对CA16 IgM CMIA和EV71 IgM CMIA的检测结果无影响,不存在交叉反应。CA16 IgM CMIA和EV71 IgM CMIA与已上市酶联免疫法检测试剂的总符合率分别为96.4%和98.9%。结论 基于磁微粒化学发光法的肠道病毒71型IgM抗体检测试剂盒和柯萨奇病毒A16型IgM抗体检测试剂盒具有良好的精密度和机载稳定性,与已上市酶免试剂对比性能良好,适用于临床大规模样本的检测。

Objective To evaluate the precision,stability and methodological comparison of enterovirus 71(EV71)and coxsackievirus A16(CA16))IgM antibody detection kits based on magnetic particle chemiluminescence, and to evaluate their clinical application value. Methods The analytical performance of IgM antibody detection kit for detecting both coxsackievirus A16 and enterovirus 71 though magnetic particle chemiluminescence immunoassay,for short CA16 IgM CMIA and EV71 IgM CMIA,was evaluated according to the relevant documents and standards of the American Society for Clinical Laboratory Standardization Institute(CLSI). The coincidence rates of CA16 IgM CMIA and EV71 IgM CMIA with ELISA kits were evaluated by receiver operating characteristic curve. Results The intra-assay precision CV of CA16IgM CMIA were 1.10% and 1.63%,and its intermediate precision CV ranged from 5.70% to 7.20%. In addition,for EV71 IgM CMIA,the intra-assay precision CV were 2.80% and 1.59%,and its intermediate precision CV ranged from 2.91% to 4.49%. The kits show excellent stability on-board. High-concentration antibody-specific sera from other pathogens with clinical symptoms similar to hand-foot-and-mouth disease or pathogen structure similar to enterovirus had no effect on the detection results of CA16 IgM CMIA and EV71IgM CMIA,and there was no cross reaction. The total coincidence rates of CA16 IgM CMIA and EV71 IgM CMIA with the marketed ELISA kits were 96.4% and 98.9%,respectively. Conclusion The enterovirus 71 IgM antibody detection kit and the coxsackie virus A16 Ig M antibody detection kit based on magnetic particle chemiluminescence have good precision and airborne stability,and have good performance compared with the marketed ELISA reagents. It is suitable for the detection of large-scale clinical samples.