[1]李团团,叶成果,李　振,等.两种RT-PCR 检测SARS-CoV-2 核酸试剂盒实验室应用评价[J].现代检验医学杂志,2020,35(03):90-93.[doi:10.3969/j.issn.1671-7414.2020.03.023]
　LI Tuan-tuan,YE Cheng-guo,LI Zhen,et al.Evaluation of Laboratory Application of Two RT-PCR Detection Kits for SARS-CoV-2 Nucleic Acid[J].Journal of Modern Laboratory Medicine,2020,35(03):90-93.[doi:10.3969/j.issn.1671-7414.2020.03.023]
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两种RT-PCR 检测SARS-CoV-2 核酸试剂盒实验室应用评价()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第35卷
期数:
2020年03期
页码:
90-93
栏目:
新型冠状病毒肺炎检验专题
出版日期:
2020-07-20

文章信息/Info

Title:
Evaluation of Laboratory Application of Two RT-PCR Detection Kits for SARS-CoV-2 Nucleic Acid
文章编号:
1671-7414（2020）03-090-04
作者:
李团团1; 叶成果2; 李　振2; 高　勇1
（1. 安徽省阜阳市第二人民医院检验科，安徽阜阳 236029；2. 上海瑟福医学检验实验室有限公司，上海 201800）
Author(s):
LI Tuan-tuan1 ; YE Cheng-guo2; LI Zhen2; GAO Yong1
（1.Department of Clinical Laboratory, the Second People’s Hospital of Fuyang City, Anhui Fuyang 236029,China； 2.Shanghai CEFU Medical Laboratory Co. Ltd，Shanghai 201800，China）
关键词:
2019 新型冠状病毒; RT-PCR 核酸检测; 试剂盒
分类号:
R373.1；R446
DOI:
10.3969/j.issn.1671-7414.2020.03.023
摘要:
目的　应用两个厂家生产的试剂盒平行检测新型冠状病毒（SARS-CoV-2）感染的肺炎（COVID-19）患者样本， 对其检测效果进行实验室应用评价。方法　A，B 两试剂盒共同靶基因为ORF1ab 和N，B 试剂盒增加靶基因E；两试 剂盒同为磁珠核酸提取，RT-PCR 扩增法。结果　298 份痰液、咽拭子、肛拭子和尿液标本中，两种试剂盒共同确认阳 性结果120 份，阴性结果178 份。其检测分别表达为：A 试剂盒ORF1ab 阳性120 份，N 阳性120 份，阴性178 份，内 标（IC）297 份，质控合格全覆盖；B 试剂盒ORF1ab 阳性120 份，N 阳性118 份，E 阳性120 份，阴性178 份，内标（IC） 298 份，质控合格全覆盖；阳性结果的Ct 值有限配对的t 检验，均P ＞ 0.05（ORF1ab:n=120,t=1.839,P=0.069；N:n=118， t=1.881，P=0.063）, 差异无统计学意义。结论　两种试剂盒表达的Ct 值趋同性较理想，标本的阳性表达上符合指南规定， 结果一致。A 试剂盒有内标（IC）1 份未能表达，不可忽视；B 试剂盒N 基因有2 份缺项需找原因克服，而具备的E 基 因提高了SARS-CoV-2 核酸检测的可控性。
Abstract:
Objective　The kits produced by the two manufacturers were used to detect samples of patients with pneumonia infected by new coronavirus in parallel, and their detection effects were evaluated for limited application. Methods　The common target genes of the two kits A and B were ORF1ab and N, and the kit B adds the target gene E, both kits were magnetic beads nucleic acid extraction, RT-PCR amplification method. Results　Of the 298 sputum, pharyngeal swabs, anal swabs and urine specimens, the two kits jointly confirmed 120 positive results and 178 negative results. The overall test expression were: 120 kits ORF1ab positive 120 and N positive 120 , 178 negative, 297 internal standard (IC), full coverage of quality control,and 120 ORF1ab positive B kit, 118 N positive, 120 E positive, 178 negative, 298 internal standard (IC) and quality full coverage of control pass.The Ct value of positive results was limited paired t test (P> 0.05)(ORF1ab: n = 120, t = 1.839,P=0.069; N: n = 118, t = 1.881, P= 0.063). The difference was not statistically significant. Conclusion　The Ct values expressed by the two kits were similar to each other, and the positive expression of the samples met the requirements of the guidelines, and the results were consistent. There was one internal standard (IC) in kit a that could not be expressed, which could not be ignored.There are two N genes in kit B that need to be overcome, while the E gene improves the controllability of 2019-ncov detection.

参考文献/References:

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备注/Memo

备注/Memo:
收稿日期：2020-05-19 修回日期：2020-05-26作者简介：李团团(1983-)，男，医学硕士，副主任检验师，主要从事临床分子生物学检验，E-mail：29515230@qq.com，Tel：15856880327。 通讯作者：高勇（1973-），男，医学硕士，副教授，主任检验师，主要从事临床检验，E-mail：fyeryuangy8@126.com
更新日期/Last Update: 2020-07-20