Clinical evaluation and application of chemiluminescence detection of SARS⁃CoV⁃2 antibodies

ABSTRACT

Objective: To investigate the detection effect and danamic changes of total antibodies and IgM antibodies of Novel Coronavirus (SARS⁃CoV⁃2) by chemiluminescence microparticle immunoassay. Methods: The confirmed COVID⁃19 group consisted of 197 patients admitted in the Zhongnan Hospital of Wuhan University, including 24 patients who with negative nucleic acid tests but confirmed by clinical symptoms and CT tests. In addition,142 patients without COVID⁃19 were set as control group. The total antibodies and IgM antibodies in the blood samples of these patients were detected by chemiluminescence. From all subjects involved in this study, we collected 242 samples for antibodies test and 853 nucleic acid test samples of all diagnosed patients at different onset times, and conducted statistical analysis on the test results of samples at different onset time points. Results: The clinical detection sensitivity respectively for total SARS⁃CoV⁃2 antibodies and IgM antibodies was 97.97% and 82.23%, respectively, and the clinical specificity was 98.59% and 100%, respectively. The detection rate of patient⁃specific total antibodies increased with time, and the detection rate of IgM antibodies showed a trend of first increasing and then decreasing. The 24 patients with negative nucleic acid tests included 24 cases had positive SARS⁃CoV⁃2 total antibodies and 21 cases had positive IgM⁃specific antibodies. Conclusion: Both detection methods have good specificity and sensitivity. The total SARS⁃CoV⁃2 total and IgM antibodies can be used as effective indicators for SARS⁃CoV⁃2 infection, but it is not suitable for early diagnosis. © 2022, Editorial Board of Medical Journal of Wuhan University. All right reserved.