Meng Qing-Bin, Peng Jing-Jing, Wei Xin, Yang Jia-Yao, Li Peng-Cheng, Qu Zi-Wei, Xiong Yong-Fen, Wu Guang-Jiang, Hu Zhi-Min, Yu Jian-Chun, Su Wen
Department of Pulmonary and Critical Care Medicine and Department of Gastrointestinal Surgery, Wuhan Integrated TCM and Western Medicine Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, Hubei Province, China.
Department of Respiratory Medicine, General Hospital of the Yangtze River Shipping, Wuhan 430015, Hubei Province, China.
World J Clin Cases. 2020 Oct 6;8(19):4360-4369. doi: 10.12998/wjcc.v8.i19.4360.
The global outbreak of human severe acute respiratory syndrome coronavirus (SARS-CoV)-2 infection represents an urgent need for readily available, accurate and rapid diagnostic tests. Nucleic acid testing of respiratory tract specimens for SARS-CoV-2 is the current gold standard for diagnosis of coronavirus disease 2019 (COVID-19). However, the diagnostic accuracy of reverse transcription polymerase chain reaction (RT-PCR) tests for detecting SARS-CoV-2 nucleic acid may be lower than optimal. The detection of SARS-CoV-2-specific antibodies should be used as a serological non-invasive tool for the diagnosis and management of SARS-CoV-2 infection.
To investigate the diagnostic value of SARS-CoV-2 IgM/IgG and nucleic acid detection in COVID-19.
We retrospectively analyzed 652 suspected COVID-19 patients, and 206 non-COVID-19 patients in Wuhan Integrated TCM and Western Medicine Hospital. Data on SARS-CoV-2 nucleic acid tests and serum antibody tests were collected to investigate the diagnostic value of nucleic acid RT-PCR test kits and immunoglobulin (Ig)M/IgG antibody test kits. The 2 test was used to compare differences between categorical variables. A 95% confidence interval (CI) was provided by the Wilson score method. All analyses were performed with IBM SPSS Statistics version 22.0 (IBM Corp., Armonk, NY, United States).
Of the 652 suspected COVID-19 patients, 237 (36.3%) had positive nucleic acid tests, 311 (47.7%) were positive for IgM, and 592 (90.8%) were positive for IgG. There was a significant difference in the positive detection rate between the IgM and IgG test groups ( < 0.001). Using the RT-PCR results as a reference, the specificity, sensitivity, and accuracy of IgM/IgG combined tests for SARS-CoV-2 infection were 98.5%, 95.8%, and 97.1%, respectively. Of the 415 suspected COVID-19 patients with negative nucleic acid test results, 366 had positive IgM/IgG tests with a positive detection rate of 88.2%.
Our data indicate that serological IgM/IgG antibody combined test had high sensitivity and specificity for the diagnosis of SARS-CoV-2 infection, and can be used in combination with RT-PCR for the diagnosis of SARS-CoV-2 infection.
全球人类严重急性呼吸综合征冠状病毒（SARS-CoV）-2感染的爆发表明迫切需要随时可用、准确且快速的诊断检测方法。对呼吸道标本进行SARS-CoV-2核酸检测是目前诊断2019冠状病毒病（COVID-19）的金标准。然而，逆转录聚合酶链反应（RT-PCR）检测用于检测SARS-CoV-2核酸的诊断准确性可能低于最佳水平。检测SARS-CoV-2特异性抗体应用作诊断和管理SARS-CoV-2感染的血清学非侵入性工具。
探讨SARS-CoV-2 IgM/IgG及核酸检测在COVID-19中的诊断价值。
我们回顾性分析了武汉市中西医结合医院652例疑似COVID-19患者和206例非COVID-19患者。收集SARS-CoV-2核酸检测和血清抗体检测数据，以研究核酸RT-PCR检测试剂盒和免疫球蛋白（Ig）M/IgG抗体检测试剂盒的诊断价值。采用χ²检验比较分类变量之间的差异。通过威尔逊评分法提供95%置信区间（CI）。所有分析均使用IBM SPSS Statistics 22.0版本（IBM公司，美国纽约州阿蒙克）进行。
在652例疑似COVID-19患者中，237例（36.3%）核酸检测呈阳性，311例（47.7%）IgM呈阳性，592例（90.8%）IgG呈阳性。IgM和IgG检测组的阳性检出率存在显著差异（P<0.001）。以RT-PCR结果为参照，SARS-CoV-2感染IgM/IgG联合检测的特异性、敏感性和准确性分别为98.5%、95.8%和97.1%。在415例核酸检测结果为阴性的疑似COVID-19患者中，366例IgM/IgG检测呈阳性，阳性检出率为88.2%。
我们的数据表明，血清学IgM/IgG抗体联合检测对SARS-CoV-2感染具有较高的敏感性和特异性，可与RT-PCR联合用于SARS-CoV-2感染的诊断。
