化学发光法检测新型冠状病毒抗体在临床的应用价值

doi:10.6040/j.issn.1671-7554.0.2020.484

摘要/Abstract

摘要： 目的探讨化学发光法检测2019新型冠状病毒(2019-nCoV)抗体在临床诊断中的应用价值。方法比较化学发光法与胶体金法对18例确诊的新型冠状病毒肺炎患者样本的检测结果,并随机挑选其中2例确诊样本梯度稀释后用以上两种方法检测其灵敏度。然后使用化学发光法检测临床确诊的39例新型冠状病毒肺炎患者的血清样本与90例健康人群的血清样本。再使用化学发光法检测不同感染时期的患者血清样本,统计不同发病时期抗体的检出率。结果两种方法检测18例确诊新型冠状病毒肺炎患者的血清样本均为阳性;2例确诊患者样本稀释625倍后用化学发光法仍可检测出抗体阳性,而胶体金法能检测出的样本最大稀释比例为25倍。对确诊患者系列标本的检测中,化学发光法的敏感度为82.05%,特异性为100%,与临床诊断一致性程度较高(Kappa值为0.864),化学发光法对血清样本中抗体的检出率随发病时间推移而升高。结论化学发光法抗体检测灵敏度高于胶体金法,自动化程度高,可用于大样本的快速筛查,其检测性能能够满足临床2019-nCoV感染病例的辅助诊断需要。

关键词: 新型冠状病毒, 化学发光法, 胶体金法, 特异性抗体

Abstract: Objective To evaluate the application value of chemiluminescent immunoassay in the detection of 2019-nCoV antibodies. Methods The sample results from 18 confirmed COVID-19 cases detected by chemiluminescent immunoassay and colloidal gold kit were compared, and 2 samples were randomly selected and tested with the above two methods after gradient dilution. The blood samples of 39 clinically diagnosed COVID-19 cases and 90 healthy controls were detected with chemiluminescent immunoassay, and the detection rates of antibodies in different stages of disease were recorded. Results Chemiluminescent immunoassay and colloidal gold method showed all of 18 patients’ samples were positive. After 625 times dilution, the 2 samples were still positive by chemiluminescent immunoassay, but the maximum dilution rate by colloidal gold reagent was 25 times. The sensitivity and specificity of chemiluminescent immunoassay for COVID-19 were 82.05% and 100%, respectively, which were consistent with the clinical diagnosis(kappa value was 0.864). The detection rate of antibodies in serum samples by chemiluminescent immunoassay increased with the time of onset. Conclusion Chemiluminescent immunoassay has higher sensitivity than colloidal gold method in the detection of 2019-nCoV antibodies, which can be used for rapid screening of a large number of samples. Chemiluminescent immunoassay can serve as a supplementary detection method of 2019-nCoV.

Key words: Novel coronavirus, Chemiluminescent immunoassay, Colloidal gold method, Specific antibody

中图分类号:

R446.6

李晓非,刘贵明,李婉澜,吕松琴,聂磊,张娟,徐丽萍,陆霓虹. 化学发光法检测新型冠状病毒抗体在临床的应用价值[J]. 山东大学学报 (医学版), 2020, 58(5): 46-50.

LI Xiaofei, LIU Guiming, LI Wanlan, LYU Songqin, NIE Lei, ZHANG Juan, XU Liping, LU Nihong. Application value of chemiluminescent immunoassay in the detection of 2019-nCoV antibodies[J]. Journal of Shandong University (Health Sciences), 2020, 58(5): 46-50.

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