实用医学杂志 ›› 2022, Vol. 38 ›› Issue (7): 791-794.doi: 10.3969/j.issn.1006⁃5725.2022.07.003

• 新型冠状病毒肺炎专栏 • 上一篇    下一篇

新型冠状病毒抗原检测胶体金法与核酸检测实时荧光RT-PCR 方法比较

许玉玲 王海霞 李金月 夏向群 黄学勇   

  1. 河南省疾病预防控制中心,传染病预防控制所,河南省传染病病原生物重点实验室(郑州 450016)

  • 出版日期:2022-04-10 发布日期:2022-04-10
  • 通讯作者: 黄学勇 E⁃mail:hxyzzu@163.com
  • 基金资助:

    河南省省部共建重大专项(编号:SBGJ202001003);新型冠状病毒防控应急攻关首批项目(编号:201100310800);河南省中青年卫生健康科技创新领军人才培养项目(编号:YXKC2020006)


RT⁃PCRComparative analysis of colloidal gold method for SARS⁃CoV⁃2 antigen detection and Real⁃Time RT⁃PCR test

XU Yuling,WANG Haixia,LI Jinyue,XIA Xiangqun,HUANG Xueyong.   

  1. He′nan Key Laboratory of Infectious Disease Microbiology,Infectious Disease Control and Prevention Institute,He′nan Provincial Center for Disease Con⁃ trol and Prevention,Zhengzhou 450016,China

  • Online:2022-04-10 Published:2022-04-10
  • Contact: HUANG Xueyong E⁃mail:hxyzzu@ 163. com

摘要:

目的 对比分析新型冠状病毒抗原检测胶体金法与核酸检测实时荧光 RT⁃PCR 方法的检测 结果,验证抗原检测胶体金法能否快速辅助诊断新型冠状病毒感染。方法 从河南省疾病预防控制中心 生物资源库挑选 2021 7⁃8 月收集的新冠阳性和新冠阴性鼻拭子各 60 份,口咽拭子各 30 份,所有样本用 实时荧光 RT⁃PCR 方法检测新冠核酸 ORF1ab N 基因,用抗原检测胶体金法检测抗原,选择 13 份阳性样 本进行 10 倍和 100 倍稀释,两种方法检测,分析胶体金法与核酸检测 RT⁃PCR 法检测结果的阳性和阴性一 致率,进行统计学 Kappa 分析。结果 180 份样本抗原检测胶体金法与核酸检测 RT⁃PCR 法的阳性符合率 98.89%,阴性符合率为 100.00%,Kappa=0.989,13 个样本 10 倍和 100 稀释后胶体金法阳性符合率分别为 100%、84.61%。结论 新型冠状病毒抗原检测胶体金法可作为早期辅助确诊新型冠状病毒感染的快速 方法。

关键词:

新型冠状病毒, 抗原检测, 胶体金法, 实时荧光

Abstract:

Objective To analyze the results between colloidal gold method for SARS ⁃CoV ⁃ 2 and real ⁃ time RT⁃PCR test and to verify whether colloidal gold method for SARS⁃CoV⁃2 can be used as a rapid auxiliary diagnosis of COVID⁃19 infection. Methods Positive and negative SARS⁃CoV⁃2 samples(60 nasal swabs and 30 pharyngeal swabs,respectively)were collected from the biological resource bank of Henan Center for Disease Control and Prevention from July to August,2021. All samples were detected by RT⁃PCR for ORF1ab and N gene and colloidal gold method for SARS ⁃CoV ⁃2 antigen. Thirteen positive samples were selected for 10 multiples and 100 multiples dilution and tested by two methods. The positive and negative consistency was analyzed by Kappa analysis. Results The positive and negative coincidence rates of colloidal gold method was 98.89% and 100.00% respectively(Kappa =0.989). The positive coincidence rates of gold standard method after 10 multiples and 100 multiples dilution was 100%,84.61% respectively. Conclusion Colloidal gold method for antigen detection can be used as an early auxiliary diagnosis method for SARS⁃CoV⁃2.

Key words:

SARS?CoV?2, antigen detection, colloidal gold method, real?time PCR