37家实验室新型冠状病毒核酸检测室间质评结果分析  

Analysis of 2019-nCoV nucleic acid testing ability in 37 Jiangxi laboratories

作　　者：姜青龙[1,2] 曾黎峰[2] 李胜远[1,2] 王征勇 李蓉 JIANG Qinglong;ZENG Lifeng;LI Rong(JiangXi Provincial Center for Clinical Laboratory,Nanchang 330006,China;Department of Clinical Laboratory,jiangxi Provicial People’s Hospital,Nanchang 330006,China)

机构地区：[1]江西省临床检验中心,江西南昌330006 [2]江西省人民医院检验科,江西南昌330006

出　　处：《实验与检验医学》2020年第4期622-625,共4页Experimental and Laboratory Medicine

摘　　要：目的调查我省新型冠状病(2019-nCoV)毒核酸检测能力,以保证检验质量。方法37家实验室均按《新型冠状病毒肺炎实验室检测技术指南》第五版要求行ORFlab和N两个基因靶标检测,各实验室分别发放5份不同批号的质控样本,与病人样本一起检测。结果1.202013和202015两个批号合格率为97.3%,其它三个批号合格率均为100.0%;2.ORFlab基因靶标的Ct值广州中山达安生产的试剂组略高,高、中、低浓度组分别为24.59±2.83,27.9±2.81,31.42±3.41。N基因Ct值其它组最高,高、中、低浓度组分别为23.89±3.02,27±2.82和29.95±2.91。结论各实验室检测结果较为理想;不同厂家试剂检测不同浓度样本结果较为一致;检测同一样本的靶核酸ORFlab基因区和N基因区的Ct值有明显差别。Objective To ensure the quality of detection of laboratories in Jiangxi province by investigating the ability of 2019-nCoV nucleic acid testing.Methods According to the Laboratory guide of 2019-nCoV detection(the Fifth Edition),ORFlab and N gene regions of 2019-nCoV in 5 samples was tested with patients’samples in 37 laboratories.Results Despite lot 202013 and 202015 were ended with a 97%passing rate,three other lots were tested to be 100%qualified.Daan Gene Company group presented a relatively high gene Ct number of ORFlab gene.The concentrations of high,moderate and low groups are 24.59±2.83,27.9±2.81,31.42±3.41,respectively.Other group presented a highest gene Ct number of N gene.The concentrations of high,moderate and low groups are 23.89±3.02,27±2.82,29.95±2.91,respectively.Conclusion Testing results of each laboratory were satisfying and results of reagents from different manufacturers were consistent.And Ct number is significant different between detection of ORFlab gene and N gene in target nucleic acids of the same sample.

关 键 词：新型冠状病毒 核酸检测 室间质评 结果分析 

分 类 号：R446.7[医药卫生—诊断学] R511[医药卫生—临床医学]