论文部分内容阅读
目的评价新型国产肠道病毒71型核酸定性检测试剂(新型定性试剂)的质量。方法首先用基于磁珠法自动化核酸提取平台的新型定性试剂和上海之江定性试剂对临床收集的EV71 RNA咽拭子和粪拭子样本进行10、100、1000、10 000倍稀释后进行多次平行检测,比较其精密度。最后,用两种定性试剂平行检测EV71 RNA阴性拭子样本和不同浓度的EV71 RNA阳性临床拭子标本,并评价其相关性和结果符合率。结果两种定性试剂测定各检测节点变异系数的结果经配对比较,EV71的咽拭子和粪拭子样本检测的精密度差异均无统计学意义(P均>0.05)。两种定性试剂检测41份临床标本的总符合率达92.86%,且显著相关(r2=0.9885,P<0.05)。结论新型定性试剂与之江定性试剂在各项指标的差异均无统计学意义,甚至某些指标更具优势,该定性试剂有良好的检测质量,可用于临床EV71 RNA检测。
Objective To evaluate the quality of a new type of qualitative detection reagent of enterovirus 71 (new qualitative reagent). Methods The clinical samples of EV71 RNA throat swabs and fecal swabs were serially diluted 10, 100, 1000 and 10,000 times with the newly developed qualitative reagents based on the magnetic bead method and the Shanghai qualitative reagents. Parallel test to compare the precision. Finally, EV71 RNA-negative swab samples and EV71 RNA-positive clinical swab specimens were tested in parallel with two qualitative reagents, and the correlation and the coincidence of the results were evaluated. Results There was no significant difference in the precision of EV71 between throat swabs and swab swabs (P> 0.05) by paired comparison between two qualitative reagents. The total coincidence rate of 41 clinical samples with the two qualitative reagents was 92.86%, which was significantly correlated (r2 = 0.9885, P <0.05). Conclusion There is no significant difference between the new qualitative reagents and the qualitative ones of Zhijiang in each index, and even some indexes have more advantages. The qualitative reagent has a good quality of detection and can be used in clinical EV71 RNA detection.