Journal of Shandong University (Health Sciences) ›› 2020, Vol. 58 ›› Issue (10): 120-126.doi: 10.6040/j.issn.1671-7554.0.2020.0741

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Development and clinical value evaluation of IgM-IgG antibody detection kit for SARS-CoV-2 infection in 15 cases

LI Huanjie1,2, OU Lanxiang3, CHEN Hong4, CHEN Jian2, GENG Jun2, GAO Zhipeng5, WANG Yan3, DING Xinglong3, CHEN Zhen3, ZHU Zhiwei3, LIU Lunqin4, Wang Yunshan1,2   

  1. 1. School of Medicine, Cheeloo College of Medicine, Shandong University, Jinan 250012, Shandong, China;
    2. Medical Research &
    Laboratory Diagnostic Center, Jinan Central Hospital, Cheeloo College of Medicine, Shandong University, Jinan 250013, Shandong, China;
    3. Shandong Laibo Biotechnology Co. Ltd, Jinan 250101, Shandong, China;
    4. Jinan Infectious Disease Hospital, Shandong University, Jinan 250021, Shandong, China;
    5. Department of Intensive Care Medicine, Weifang Peoples Hospital, Weifang 261000, Shandong, China
  • Published:2020-10-08

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Abstract: Objective To develop a colloidal gold kit for rapid detection of IgM-IgG antibodies of SARS-CoV-2, optimize the development and application strategy, and investigate the diagnostic value of SARS-CoV-2 IgM-IgG antibodies by detecting serum of clinically confirmed patients. Methods The RBD and NTD domains of S protein from SARS-CoV-2 virus were expressed and purified to prepare IgM-IgG antibody colloidal gold detection kit by coating antigen and polyclonal antibody with preparation technique of colloidal gold, then the clinical efficacy was validated. The blood samples collected from 15 PCR confirmed COVID-19 patients were detected and the positive rate was calculated to analyze the response progress of SARS-CoV-2 antibody IgM-IgG on virus. Results The overall positive rate of IgM-IgG antibody assay test was 73.33%, which was higher that single IgM(positive rate: 53.33%)or IgG(positive rate: 60.00%)test. Three cases were positive out of five aliens. The epidemiology analyses showed that 7 positive cases had infected with SARS-CoV-2 virus for more than one week. The sensitivity of the antibody detection kit was 73.33% and the specificity was 95.00%. Conclusion The IgM-IgG combined test method is rapid, convenient and easy to operate, and can be used to carry on the primary screening for the suspected patients, especially the aliens and asymptomatic patients. On the other hand, the IgM-IgG detection result can be used as the basis to infer the virus-infected progress. The rapid dection results of IgM-IgG antibody may be helpful for the diagnosis and treatment on COVID-19.

Key words: SARS-CoV-2, IgM-IgG antibody detection, COVID-19, Nucleic acid test, Colloidal gold method

CLC Number: 

  • R446.5
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