Development, Performance Evaluation and Clinical Application of A Rapid SARS‐CoV‐2 IgM and IgG Test Kit Based on Automated Fluorescence Immunoassay

Kang, Keren; Huang, Lingfang; Ouyang, Chaolin; Du, Jiaming; Yang, Bin; Chi, Yaqin; He, Shuyu; Ying, Le; Chen, Guoling; Wang, Jihua

The ongoing COVID‐19 epidemic has made a huge impact on health, economies, and societies all over the world. Although RT‐PCR‐based nucleic acid detection has been primarily used in the diagnosis of COVID‐19, it is time‐consuming with limited application scenarios and must be operated by qualified personnel. Antibody test, particularly point‐of‐care antibody testing, is a suitable complement to nucleic acid test as it provides rapid, portable, and cost‐effective detection of infections. In this study, a rapid antibody test kit was developed based on fluorescence immunochromatography for the sensitive, accurate, and automated detection of IgM and IgG antibodies against SARS‐CoV‐2 in human serum, plasma, and whole blood samples within 10 minutes. The sensitivity, specificity, precision, and stability of the test kit were of good performance. No cross‐activity and no interference was observed. In the multiple‐center parallel study, 223 samples from hospitalized patients were used to evaluate the clinical specificity of the test. Both SARS‐CoV‐2 IgM and IgG achieved a clinical specificity of 98.21%. The clinical sensitivities of SARS‐CoV‐2 IgM and IgG were 79.54% and 87.45%, respectively, among 733 RT‐PCR confirmed SARS‐Cov‐2 samples. For the combined IgM and IgG assays, the sensitivity and specificity were 89.22% and 96.86%, respectively. Our results demonstrate that the combined use of IgM and IgG could serve as a more suitable alternative detection method for COVID‐19 patients, and the developed kit is of great public health significance for the prevention and control of the COVID‐19 pandemic. This article is protected by copyright. All rights reserved.