Retrospective Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Oct 6, 2020; 8(19): 4360-4369
Published online Oct 6, 2020. doi: 10.12998/wjcc.v8.i19.4360
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
Qing-Bin Meng, 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
Jing-Jing Peng, Department of Respiratory Medicine, General Hospital of the Yangtze River Shipping, Wuhan 430015, Hubei Province, China
Xin Wei, Department of Gastrointestinal Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430000, Hubei Province, China
Jia-Yao Yang, Department of Gastroenterology, Wuhan Integrated TCM and Western Medicine Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, Hubei Province, China
Peng-Cheng Li, Yong-Fen Xiong, 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
Zi-Wei Qu, 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
Guang-Jiang Wu, Department of Infection Management and Disease Control, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, China
Zhi-Min Hu, 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
Jian-Chun Yu, Department of General Surgery, Peking Union Medicine College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China
Wen Su, 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
Author contributions: Meng QB, Peng JJ, Wei X and Su W designed the research; Meng QB, Peng JJ, Wei X Yang JY, Qu ZW, Li PC, Xiong YY and Hu ZM collected the data; Wu GJ, Yang JY, Meng QB, Su W and Yu JC analyzed the data; Wu GJ did the statistical review of the study; Meng QB, Peng JJ and Wei X wrote the paper; all authors have read and approved the final manuscript.
Supported by Natural Science Foundation of Hubei Province, China, No. 2016CFB596; and Wuhan City Medical Research Project, China, No. WX17Q39 and No. WX15B14.
Institutional review board statement: The study was reviewed and approved by the Ethics Committee of Wuhan Integrated TCM and Western Medicine Hospital, Huazhong University of Science and Technology (Approval No. [2020]8).
Informed consent statement: The requirement for written informed consent was waived given the context of emerging infectious diseases.
Conflict-of-interest statement: All the authors have no potential conflicts of interest related to the manuscript.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Wen Su, MD, PhD, Dean, Professor, Department of Science and Education, Wuhan Integrated TCM and Western Medicine Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 215 Zhongshan Avenue, Wuhan 430022, Hubei Province, China. 501820747@qq.com
Received: April 19, 2020
Peer-review started: April 19, 2020
First decision: July 25, 2020
Revised: August 8, 2020
Accepted: September 2, 2020
Article in press: September 2, 2020
Published online: October 6, 2020
Processing time: 161 Days and 9.6 Hours
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: SARS-CoV-2; COVID-19; Nucleic acid detection; Immunoglobulin M; Immunoglobulin G; Diagnosis

Core Tip: We retrospectively analyzed 652 suspected coronavirus disease 2019 (COVID-19) patients, and 206 non-COVID-19 patients to investigate the diagnostic value of severe acute respiratory syndrome coronavirus (SARS-CoV)-2 IgM/IgG and nucleic acid detection. We found that 237/652 (36.3%) suspected COVID-19 patients had positive nucleic acid tests, 311 (47.7%) were positive for IgM, and 592 (90.8%) were positive for IgG. Using reverse transcription polymerase chain reaction (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. Our data indicate that the serological IgM/IgG combined test can be used in combination with RT-PCR for the diagnosis of SARS-CoV-2 infection.