Evaluation of three colloidal gold reagents for SARS-CoV-2 antibody and the control strategy of false positive_Chinese Journal of Respiratory and Critical Care Medicine

Authors：

WANG Yuanfang , DENG Jielun , AO Keping ,  LI Dongdong , XIE Yi , YING Binwu

Clinical Laboratory of West China Hospital of Sichuan University, Chengdu, Sichuan 610041, P. R. China;

Corresponding author：

LI Dongdong, Email: jiangxili1219@163.com

Keywords：

SARS-CoV-2; IgM/IgG antibodies; GICA rapid diagnostic tests

DOI：

10.7507/1671-6205.202003194

Video：

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Objective To analyze the diagnostic efficacy of colloidal gold immunochromatography assay (GICA) in detection of SARS-CoV-2.Methods Using GICA detection kits from three different manufacturers, 33 serum samples were collected from 12 patients with SARS-CoV-2 infection at different time and 45 serum samples from 45 patients without SARS-CoV-2 infection were collected from West China Hospital of Sichuan University from January to February, 2020.Results The sensitivity, specificity, positive predictive value and negative predictive value of the three GICA reagents were 66.7% - 90.9%, 73.3% - 100.0%, 71.4% - 100.0% and 80.4% - 91.7% respectively. The rates of missed diagnosis and misdiagnosis were 9.1% - 33.3% and 0 - 26.7%, respectively. The positive rate decreased with titer increasing. The interference factors mainly included human immunodeficiency virus infection, high rheumatoid factor blood samples, and hemolysis.Conclusion Clinical laboratories should pay attention to the differences in the detection ability and potential cross-reaction of different reagents, or use a combination of multiple antibodies.

Citation： WANG Yuanfang, DENG Jielun, AO Keping, LI Dongdong, XIE Yi, YING Binwu. Evaluation of three colloidal gold reagents for SARS-CoV-2 antibody and the control strategy of false positive. Chinese Journal of Respiratory and Critical Care Medicine, 2020, 19(3): 214-218. doi: 10.7507/1671-6205.202003194 Copy

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11.	张波, 刘红鹰, 府伟灵, 等. 血清新型冠状病毒特异性抗体水平的检测及其动态变化规律. 中华内科杂志, 2004, 43(6): 58-59.
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14.	Meyer B, Drosten C, Müller MA. Serological assays for emerging coronaviruses: challenges and pitfalls. Virus Res, 2014, 194: 175-183.
15.	Chen YX, Chan KH, Kang YH, et al. A sensitive and specific antigen detection assay for Middle East respiratory syndrome coronavirus. Emerg Microbes Infect, 2015, 4(4): e26.
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17.	Sun ZF, Meng XJ. Antigenic cross-reactivity between the nucleocapsid protein of severe acute respiratory syndrome (SARS) coronavirus and polyclonal antisera of antigenic group I animal coronaviruses: implication for SARS diagnosis. J Clin Microbiol, 2004, 42(5): 2351-2352.
18.	Fukushi S, Fukuma A, Kurosu T, et al. Characterization of novel monoclonal antibodies against the MERS-coronavirus spike protein and their application in species-independent antibody detection by competitive ELISA. J Virol Methods, 2018, 251: 22-29.
19.	Lee JH, Jang JW, Cho CH, et al. False-positive results for rapid diagnostic tests for malaria in patients with rheumatoid factor. J Clin Microbiol, 2014, 52(10): 3784-3787.
20.	Zhang C, Zheng W, Huang X, et al. Protein structure and sequence reanalysis of 2019-nCoV genome refutes snakes as its intermediate host and the unique similarity between its spike protein insertions and HIV-1. J Proteome Res, 2020, 19(4): 1351-1360.
21.	Schiettecatte J, Anckaert E, Smitz J. Interferences in Immunoassays. In: Chiu NHL, editor. Advances in Immunoassay Technology. London: InTech, 2012, 45-62.

1. Lu HZ, Stratton CW, Tang YW, Outbreak of pneumonia of unknown etiology in Wuhan China: the mystery and the miracle[J/OL]. J Med Virol. [2020-01-16]. https://doi.org/10.1002/jmv.25678.
2. Hui DS, Azhar EI, Madani TA, et al. The continuing 2019-nCoVepidemic threat of novel coronaviruses to global health - the latest 2019 novel coronavirus outbreak in Wuhan, China. Int J Infect Dis, 2020, 91: 264-266.
3. Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet, 2020, 395(10223): 497-506.
4. Channappanavar R, Fett C, Mack M, et al. Sex-based differences in susceptibility to severe acute respiratory syndrome coronavirus infection. J Immunol, 2017, 198(10): 4046-4053.
5. Jung SM, Akhmetzhanov AR, Hayashi K, et al. Real-time estimation of the risk of death from novel coronavirus (COVID-19) infection: inference using exported cases. J Clin Med, 2020, 9(2): pii E523.
6. Trivedi S, Miao CR, Al-Abdallat MM, et al. Inclusion of MERS-spike protein ELISA in algorithm to determine serologic evidence of MERS-CoV infection. J Med Virol, 2018, 90(2): 367-371.
7. Corman VM, Landt O, Kaiser M, et al. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill, 2020, 25(3): pii 2000045.
8. Zhang W, Du RH, Li B, et al. Molecular and serological investigation of 2019-nCoV infected patients: implication of multiple shedding routes. Emerg Microbes Infect, 2020, 9(1): 386-389.
9. 国家卫生健康委员会办公厅.新型冠状病毒感染的肺炎诊疗方案(试行第七版)[EB/OL]. (2020-03-04). http://www.nhc.gov.cn/ yzygj/s7653p/202003/46c9294a7dfe4cef80dc7f5912eb1989.shtml..
10. Xiao SY, Wu YJ, Liu H. Evolving status of the 2019 novel coronavirus infection: Proposal of conventional serologic assays for disease diagnosis and infection monitoring. J Med Virol, 2020, 92(5): 464-467.
11. 张波, 刘红鹰, 府伟灵, 等. 血清新型冠状病毒特异性抗体水平的检测及其动态变化规律. 中华内科杂志, 2004, 43(6): 58-59.
12. Chan KH, Poon LL, Cheng VCC, et al. Detection of SARS coronavirus in patients with suspected SARS. Emerg Infect Dis, 2004, 10(2): 294-299.
13. 钟慧钰, 赵珍珍, 宋兴勃, 等. 新型冠状病毒核酸临床检测要点及经验. 国际检验医学杂志, 2020, 41(5): 523-526.
14. Meyer B, Drosten C, Müller MA. Serological assays for emerging coronaviruses: challenges and pitfalls. Virus Res, 2014, 194: 175-183.
15. Chen YX, Chan KH, Kang YH, et al. A sensitive and specific antigen detection assay for Middle East respiratory syndrome coronavirus. Emerg Microbes Infect, 2015, 4(4): e26.
16. Lu R, Zhao X, Li J, et al. Genomic characterisation and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding. Lancet, 2020, 395(10224): 565-574.
17. Sun ZF, Meng XJ. Antigenic cross-reactivity between the nucleocapsid protein of severe acute respiratory syndrome (SARS) coronavirus and polyclonal antisera of antigenic group I animal coronaviruses: implication for SARS diagnosis. J Clin Microbiol, 2004, 42(5): 2351-2352.
18. Fukushi S, Fukuma A, Kurosu T, et al. Characterization of novel monoclonal antibodies against the MERS-coronavirus spike protein and their application in species-independent antibody detection by competitive ELISA. J Virol Methods, 2018, 251: 22-29.
19. Lee JH, Jang JW, Cho CH, et al. False-positive results for rapid diagnostic tests for malaria in patients with rheumatoid factor. J Clin Microbiol, 2014, 52(10): 3784-3787.
20. Zhang C, Zheng W, Huang X, et al. Protein structure and sequence reanalysis of 2019-nCoV genome refutes snakes as its intermediate host and the unique similarity between its spike protein insertions and HIV-1. J Proteome Res, 2020, 19(4): 1351-1360.
21. Schiettecatte J, Anckaert E, Smitz J. Interferences in Immunoassays. In: Chiu NHL, editor. Advances in Immunoassay Technology. London: InTech, 2012, 45-62.

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Evaluation of three colloidal gold reagents for SARS-CoV-2 antibody and the control strategy of false positive

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