Published online Oct 6, 2020. doi: 10.12998/wjcc.v8.i19.4360
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
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).
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.
The objectives were to report the diagnostic value of SARS-CoV-2 IgM/IgG and nucleic acid detection in COVID-19.
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.
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%.
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.
For COVID-19 patients, it is worth further completing the dynamic monitoring of SARS-CoV-2-specific IgM and IgG.