Establishment and clinical performance evaluation of 2019 novel coronavirus antibody colloidal gold detection method
10.3760/cma.j.issn.1000-6680.2020.03.003
- VernacularTitle:2019新型冠状病毒抗体胶体金检测方法的建立与临床性能评价
- Author:
Hui LI
1
;
Yongyin LI
;
Zhigao ZHANG
;
Zhen LU
;
Yi WANG
;
Guanfeng LIN
;
Taixue AN
;
Xiumei HU
;
Qintao LAI
;
Xuan YI
;
Zhihong LIU
;
Xiangming ZHAI
;
Jian SUN
;
Yabing GUO
;
Jiatao LU
;
Xiaoyong ZHANG
;
Yingsong WU
;
Jinlin HOU
Author Information
1. 南方医科大学南方医院感染内科 器官衰竭防治国家重点实验室 广东省病毒性肝炎研究重点实验室，广州 510515
- From:
Chinese Journal of Infectious Diseases
2020;38(3):139-144
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish a colloidal gold technique assay for the rapid detection of immunoglobulin(Ig)M and IgG antibodies against 2019 novel coronavirus (2019-nCoV) and to evaluate its clinical performance.Methods:A total of 278 patients who were respectively treated at Wuhan Hankou Hospital and the People′s Hospital of Honghu from February 12, 2020 to February 20, 2020 were collected. According to the diagnostic criteria, 89 patients were confirmed with positive 2019-nCoV nucleic acid, and 189 were 2019-nCoV nucleic acid-negative suspected patients. A total of 273 medical examiners from Nanfang Hospital, Southern Medical University from 2015 to 2018 were selected as controls. The serum samples of patients were collected. 2019-nCoV nucleic proteins were obtained from prokaryotic expression vectors. Indirect IgM and IgG colloidal gold techniques were established by using recombinant nuclear protein. 2019-nCoV nucleic acid detection by reverse transcription-polymerase chain reaction (RT-PCR) was used as control. Serum specimens were tested for 2019-nCoV IgM and IgG. The specificity and sensitivity of colloidal gold assay were analyzed.Results:The positive rates of IgM and IgG with the colloidal gold detection in confirmed patients with positive 2019-nCoV nucleic acid were 78.7%(70/89) and 73.0%(65/89), respectively. The positive rates of IgM and IgG in medical examiners were 1.8%(5/273) and 0.7%(2/273), respectively. The sensitivity and specificity of IgM detection reagents were 78.7% and 98.2%, respectively, those of IgG detection reagents were 73.0% and 99.3%, respectively, and those of IgM combined with IgG detection were 87.6% and 98.2%, respectively. For suspected patients with negative 2019-nCoV nucleic acid, the positive rates of IgM and IgG were 59.8%(113/189) and 52.9%(100/189), respectively, and the positive rate of IgM combined with IgG detection was 66.1%(125/189).Conclusion:This reagent of 2019-nCoV antibodies detection (colloidal gold technique) fulfills the requirement for clinical application with high specificity and sensitivity, which can be served as a supplementary detection method for 2019-nCoV nucleic acid detection by RT-PCR.
