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管红霞, 马广源, 马丹, 陈恩品, 肖勇. 新型冠状病毒感染核酸和抗体检测方法比较[J]. 中国公共卫生, 2020, 36(10): 1399-1401. DOI: 10.11847/zgggws1129498
引用本文: 管红霞, 马广源, 马丹, 陈恩品, 肖勇. 新型冠状病毒感染核酸和抗体检测方法比较[J]. 中国公共卫生, 2020, 36(10): 1399-1401. DOI: 10.11847/zgggws1129498
GUAN Hong-xia, MA Guang-yuan, MA Dan, . Diagnostic significance of SARS-CoV-2 nucleic acid and antibody detection: a retrospective comparison study[J]. Chinese Journal of Public Health, 2020, 36(10): 1399-1401. DOI: 10.11847/zgggws1129498
Citation: GUAN Hong-xia, MA Guang-yuan, MA Dan, . Diagnostic significance of SARS-CoV-2 nucleic acid and antibody detection: a retrospective comparison study[J]. Chinese Journal of Public Health, 2020, 36(10): 1399-1401. DOI: 10.11847/zgggws1129498

新型冠状病毒感染核酸和抗体检测方法比较

Diagnostic significance of SARS-CoV-2 nucleic acid and antibody detection: a retrospective comparison study

  • 摘要:
      目的  比较实时荧光RT-PCR法和胶体金法在新型冠状病毒(SARS-CoV-2)感染中的诊断价值。
      方法  本研究采用回顾性研究,收集无锡市各医疗机构及集中隔离点2020年1月25日 — 2020年2月12日送至无锡市疾病预防控制中心实验室的新型冠状病毒冠肺炎(COVID-19)相关的实验室检测血清标本和鼻咽拭子标本各192份。33份为核酸检测阳性样本,159份为核酸检测阴性样本,包括68例确诊患者的密切接触者和91例门诊发热病例样本。采用胶体金法对所有研究对象的血清进行IgM、IgG抗体检测,比较抗体检测和核酸检测结果,进行统计学差异分析。
      结果  病毒核酸阳性率17.19 %(33/192),IgM抗体阳性率7.29 %(14/192),IgG抗体阳性率11.46 %(22/192),IgM和IgG联合检测阳性率11.46 %(22/192)。病毒核酸和IgM、IgG、联合IgM和IgG抗体检测结果分别进行Kappa一致性检验,一致性较好,Kappa值分别为0.502、0.726、0.726,P值均 < 0.001。两种检测方法总符合率93.23 %(179/192)。以实时荧光RT-PCR法为金标准,联合IgM和IgG抗体检测灵敏度63.64 %,特异度99.37 %,阳性预测值95.45 %,阴性预测值92.94 %,准确度63.01 %。
      结论  胶体金法具有方便、快捷、灵敏度和特异度高等优点,实现SARS-CoV-2的快速筛查,可用作实时荧光RT-PCR检测阴性病例的补充检测。两种检测方法联合应用,发挥各自优势,对SARS-CoV-2感染的诊断和防控具有重要的意义。

     

    Abstract:
      Objective  To compare the significance of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid and antibody detection for diagnosis of the virus infection.
      Methods   Totally 192 serum samples and 192 nasopharyngeal swab specimens (33 negative and 159 positive for SARS-CoV-2) were collected from 68 confirmed corona-virus disease 2019 (COVID-19) cases and their close contacts and 91 attendees of fever clinics at medical institutions or centralized quarantine sites in Wuxi city of Jiangsu province between January 25 and February12, 2020. The swab specimens were detected for SARS-CoV-2 nucleic acid with fluorescence-based real-time reverse transcription PCR (RT-PCR) and the serum samples were detected for immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies of SARS-CoV-2 with colloidal gold method retrospectively.
      Results  The positive rate of SARS-CoV-2 nucleic acid was 17.19% (33/192) for the swab specimens; for the serum samples, the antibody-positive rates were 7.29% (14/192) for IgM, 11.46% (22/192) for IgG, and 11.46% (22/192) for either IgM or IgG, respectively. The results of Kappa test indicated a good consistency between detections of viral nucleic acid and IgM, IgG and IgM/IgG, with the Kappa values of 0.502, 0.726 and 0.726 (all P < 0.001). The total compliance rate of the two detection methods was 93.23% (179/192).With the RT-PCR results of swab specimen viral nucleic acid as the gold standard, the indicators of colloidal gold serum IgM/IgG antibody detection for SARS-CoV-2 infection were 63.64% for sensitivity, 99.37% for specificity, 95.45% for positive predictive value, 92.94% for negative predictive value, and 63.01% for accuracy, respectively.
      Conclusion   Colloidal gold detection of serum IgM and IgG antibody is of convenience, rapidity, high sensitivity and specificity in the screening of SARS-CoV-2 infection and could be used as a supplementary detection among viral nucleic acid negative cases in RT-PCR test. The combined application of the two detections may play an important role in the diagnosis, prevention and control of COVID-19.

     

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