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Clinical application of combined detection of SARS-CoV-2-specific antibody and nucleic acid

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单位: [1]Huazhong Univ Sci & Technol, Tongji Med Coll, Wuhan Integrated TCM & Western Med Hosp, Dept Pulm & Crit Care Med, Wuhan 430022, Hubei, Peoples R China [2]Huazhong Univ Sci & Technol, Tongji Med Coll, Wuhan Integrated TCM & Western Med Hosp, Dept Gastrointestinal Surg, Wuhan 430022, Hubei, Peoples R China [3]Gen Hosp Yangtze River Shipping, Dept Resp Med, Wuhan 430015, Hubei, Peoples R China [4]Huazhong Univ Sci & Technol,Tongji Hosp,Tongji Med Coll,Dept Gastrointestinal Surg,Wuhan 430000,Hubei,Peoples R China [5]Huazhong Univ Sci & Technol, Wuhan Integrated TCM & Western Med Hosp, Tongji Med Coll, Dept Gastroenterol, Wuhan 430022, Hubei, Peoples R China [6]Huazhong Univ Sci & Technol, Wuhan Integrated TCM & Western Med Hosp, Tongji Med Coll, Dept Transfus Med, Wuhan 430022, Hubei, Peoples R China [7]Capital Med Univ, Beijing Shijitan Hosp, Dept Infect Management & Dis Control, Beijing 100038, Peoples R China [8]Huazhong Univ Sci & Technol, Wuhan Integrated TCM & Western Med Hosp, Tongji Med Coll, Dept Clin Microbiol & Mol Biol, Wuhan 430022, Hubei, Peoples R China [9]Chinese Acad Med Sci, Peking Union Med Coll Hosp, Dept Gen Surg, Beijing 100730, Peoples R China [10]Huazhong Univ Sci & Technol, Wuhan Integrated TCM & Western Med Hosp, Tongji Med Coll, Dept Sci & Educ, 215 Zhongshan Ave, Wuhan 430022, Hubei, Peoples R China
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关键词: SARS-CoV-2 COVID-19 Nucleic acid detection Immunoglobulin M Immunoglobulin G Diagnosis

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BACKGROUND 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. AIM To investigate the diagnostic value of SARS-CoV-2 IgM/IgG and nucleic acid detection in COVID-19. METHODS 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 chi(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). RESULTS 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 (P < 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%. CONCLUSION 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.

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出版当年[2019]版:
大类 | 4 区 医学
小类 | 4 区 医学:内科
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Q3 MEDICINE, GENERAL & INTERNAL
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Q3 MEDICINE, GENERAL & INTERNAL

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第一作者单位: [1]Huazhong Univ Sci & Technol, Tongji Med Coll, Wuhan Integrated TCM & Western Med Hosp, Dept Pulm & Crit Care Med, Wuhan 430022, Hubei, Peoples R China [2]Huazhong Univ Sci & Technol, Tongji Med Coll, Wuhan Integrated TCM & Western Med Hosp, Dept Gastrointestinal Surg, Wuhan 430022, Hubei, Peoples R China
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