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

Qing-Bin Meng; Jing-Jing Peng; Xin Wei; Jia-Yao Yang; Peng-Cheng Li; Zi-Wei Qu; Yong-Fen Xiong; Guang-Jiang Wu; Zhi-Min Hu; Jian-Chun Yu; Wen Su

doi:10.12998/wjcc.v8.i19.4360

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

World J Clin Cases. 2020 Oct 6;8(19):4360-4369. doi: 10.12998/wjcc.v8.i19.4360.

Authors

Qing-Bin Meng¹, Jing-Jing Peng², Xin Wei³, Jia-Yao Yang⁴, Peng-Cheng Li⁵, Zi-Wei Qu⁶, Yong-Fen Xiong⁵, Guang-Jiang Wu⁷, Zhi-Min Hu⁸, Jian-Chun Yu⁹, Wen Su¹⁰

Affiliations

¹ 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.
² Department of Respiratory Medicine, General Hospital of the Yangtze River Shipping, Wuhan 430015, Hubei Province, China.
³ Department of Gastrointestinal Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430000, Hubei Province, China.
⁴ Department of Gastroenterology, Wuhan Integrated TCM and Western Medicine Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, Hubei Province, China.
⁵ Department of Transfusion Medicine, Wuhan Integrated TCM and Western Medicine Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, Hubei Province, China.
⁶ 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.
⁷ Department of Infection Management and Disease Control, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, China.
⁸ Department of Clinical Microbiology and Molecular Biology, Wuhan Integrated TCM and Western Medicine Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, Hubei Province, China.
⁹ Department of General Surgery, Peking Union Medicine College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China.
¹⁰ Department of Science and Education, Wuhan Integrated TCM and Western Medicine Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, Hubei Province, China. 501820747@qq.com.

Abstract

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 χ2 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.

Keywords: COVID-19; Diagnosis; Immunoglobulin G; Immunoglobulin M; Nucleic acid detection; SARS-CoV-2.