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©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
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
ARTICLE HIGHLIGHTS
Research background
Coronavirus disease 2019 (COVID-19) is a highly transmissible disease caused by severe acute respiratory syndrome coronavirus (SARS-CoV)-2. The global outbreak of human SARS-CoV-2 infection has highlighted the necessity for readily available, accurate and rapid diagnostic tests. SARS-CoV-2 serum IgM and IgG antibody positivity was added to the diagnostic criteria in the Novel Coronavirus Pneumonia Diagnosis and Treatment Guidelines (Trial Version 7). However, there is limited clinical information on the SARS-CoV-2 antibody test (colloidal gold).
Research motivation
According to recent evidence, the diagnostic accuracy of reverse transcription polymerase chain reaction (RT-PCR) tests for detecting SARS-CoV-2 nucleic acid may be lower than optimal. Given the limitations of RT-PCR tests for the diagnosis of COVID-19, clinical laboratories should apply sensitive and accurate assays such as immunological detection kits that target viral antigens or antibodies for diagnosing SARS-CoV-2 infection as quickly as possible. We are very interested in this issue and hope that we can present a new antibody test adopted in our hospital.
Research objectives
The objectives were to report the diagnostic value of SARS-CoV-2 IgM/IgG and nucleic acid detection in COVID-19.
Research methods
We retrospectively analyzed data on 652 suspected COVID-19 patients, and 206 non-COVID-19 patients in Wuhan Integrated TCM and Western Medicine Hospital. RT-PCR, SARS-CoV-2 IgM/IgG antibody tests, and pulmonary imaging features were extracted from patients’ electronic medical records in our hospital information system. The specificity, sensitivity, PPV and NPV of the SARS-CoV-2 Antibody Test Kit were calculated. 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), and two-tailed P values less than 0.05 were considered to be statistically significant.
Research results
Of the 652 suspected COVID-19 patients, 237 (36.3%) patients were confirmed to have COVID-19 by the SARS-CoV-2 nucleic acid RT-PCR test. Using RT-PCR results as a reference, the specificity, sensitivity, and accuracy of the SARS-CoV-2-specific IgM/IgG combined tests for detecting SARS-CoV-2 infection were 98.5%, 95.8%, and 97.1%, respectively. Of the 415 suspected COVID-19 patients who were negative for the SARS-CoV-2 nucleic acid tests, 366 patients were positive for the SARS-CoV-2-specific IgM and/or IgG antibody tests with a positive detection rate of 88.2%.
Research conclusions
Our data indicate that the serological IgM/IgG antibody combined test had high specificity, sensitivity, and accuracy 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.
Research perspectives
For COVID-19 patients, it is worth further completing the dynamic monitoring of SARS-CoV-2-specific IgM and IgG.
