Development and clinical application of a rapid IgM‐IgG combined antibody test for SARS‐CoV‐2 infection diagnosis

• Published in: Journal of medical virology Vol. 92; no. 9; pp. 1518 - 1524
• Main Authors: Li, Zhengtu, Yi, Yongxiang, Luo, Xiaomei, Xiong, Nian, Liu, Yang, Li, Shaoqiang, Sun, Ruilin, Wang, Yanqun, Hu, Bicheng, Chen, Wei, Zhang, Yongchen, Wang, Jing, Huang, Baofu, Lin, Ye, Yang, Jiasheng, Cai, Wensheng, Wang, Xuefeng, Cheng, Jing, Chen, Zhiqiang, Sun, Kangjun, Pan, Weimin, Zhan, Zhifei, Chen, Liyan, Ye, Feng
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01.09.2020; John Wiley and Sons Inc
• Subjects: Antibodies; Antibodies, Viral - blood; Antibodies, Viral - immunology; Asymptomatic; Blood; Coronaviridae; Coronaviruses; COVID-19; COVID-19 - diagnosis; COVID-19 - immunology; COVID-19 - virology; Diagnosis; Disease transmission; fingerstick blood; Humans; Immunoassay; Immunoassay - methods; Immunoglobulin G; Immunoglobulin G - blood; Immunoglobulin G - immunology; Immunoglobulin M; Immunoglobulin M - blood; Immunoglobulin M - immunology; Infections; lateral flow immunoassay; Nucleic acids; Patients; Point-of-Care Testing; Polymerase chain reaction; rapid IgM‐IgG combined test; Reagent Kits, Diagnostic; Reagent Strips; Respiratory diseases; SARS-CoV-2 - immunology; SARS‐CoV‐2 virus infection; Sensitivity; Sensitivity analysis; Sensitivity and Specificity; Severe acute respiratory syndrome; Severe acute respiratory syndrome coronavirus 2; Viral diseases; Virology; Viruses; COVID-19; point-of-care testing; rapid IgM-IgG combined test; fingerstick blood; lateral flow immunoassay; SARS-CoV-2 virus infection
• ISSN: 0146-6615; 1096-9071; 1096-9071
• DOI: 10.1002/jmv.25727

The outbreak of the novel coronavirus disease (COVID‐19) quickly spread all over China and to more than 20 other countries. Although the virus (severe acute respiratory syndrome coronavirus [SARS‐Cov‐2]) nucleic acid real‐time polymerase chain reaction (PCR) test has become the standard method for diagnosis of SARS‐CoV‐2 infection, these real‐time PCR test kits have many limitations. In addition, high false‐negative rates were reported. There is an urgent need for an accurate and rapid test method to quickly identify a large number of infected patients and asymptomatic carriers to prevent virus transmission and assure timely treatment of patients. We have developed a rapid and simple point‐of‐care lateral flow immunoassay that can detect immunoglobulin M (IgM) and IgG antibodies simultaneously against SARS‐CoV‐2 virus in human blood within 15 minutes which can detect patients at different infection stages. With this test kit, we carried out clinical studies to validate its clinical efficacy uses. The clinical detection sensitivity and specificity of this test were measured using blood samples collected from 397 PCR confirmed COVID‐19 patients and 128 negative patients at eight different clinical sites. The overall testing sensitivity was 88.66% and specificity was 90.63%. In addition, we evaluated clinical diagnosis results obtained from different types of venous and fingerstick blood samples. The results indicated great detection consistency among samples from fingerstick blood, serum and plasma of venous blood. The IgM‐IgG combined assay has better utility and sensitivity compared with a single IgM or IgG test. It can be used for the rapid screening of SARS‐CoV‐2 carriers, symptomatic or asymptomatic, in hospitals, clinics, and test laboratories.