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化学发光法检测新型冠状病毒特异性抗体的假阳性结果评价 被引量:8

An Evaluation of False Positive Results of Chemiluminescence Assay for the Detection of Novel Coronavirus Specific Antibodies
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摘要 目的探讨化学发光法检测新型冠状病毒(2019 novel coronavirus)特异性抗体IgM和IgG假阳性结果的可能原因及相关性分析,为新型冠状病毒肺炎诊治提供有利依据。方法回顾性研究2020年7月1日至2021年1月31日就诊于北京市海淀医院的患者32136例,采集血液标本用化学发光法进行特异性抗体IgM和IgG检测,阳性的患者均进行实时荧光RT-PCR新型冠状病毒核酸检测。结果32136例样本中检出IgM阳性226例,IgG阳性452例,阳性的标本再进行核酸检测,结合诊断标准、临床表现、流行病学调查,2例为确诊阳性,其余均为假阳性。IgM抗体假阳性率为0.70%(224/32136),IgG抗体假阳性率为1.40%(450/32136),其男性女性假阳性率差异无统计学意义(P>0.05)。年龄组≤20岁、21~30岁、31~40岁、41~50岁、51~60岁、>60岁组中新型冠状病毒特异性抗体IgM假阳性率均低于IgG抗体假阳性率,>60岁老年组的IgM和IgG抗体的假阳性率最高,与其他年龄组比较,差异有统计学意义(P<0.05)。同时随着年龄的增加,IgG抗体假阳性率也逐渐增加。假阳性患者中肿瘤患者引起抗体假阳性率最高。结论新冠抗体的检测虽然可以作为多次核酸检测阴性而临床有症状或影像学有特异性改变的患者的辅助诊断手段,但不适用于大规模一般人群筛查。同时还要有效识别干扰因素对新冠抗体检测结果的影响,为新型冠状病毒感染的诊断与治疗提供帮助。 Objective To investigate the possible causes and correlation analysis of false positive results of IgM and IgG specific antibodies detected by chemiluminescence assay for Novel Coronavirus(2019-nCoV),and to provide a potential useful basis for the diagnosis and treatment of COVID-19.Methods A retrospective study was conducted on 32,136 patients admitted to Beijing Haidian Hospital from July 1,2020 to January 31,2021.Blood samples were collected and detected by chemiluminescence method for specific antibody IgM and IgG.All positive patients were tested by real-time fluorescence RT-PCR novel coronavirus nucleic acid.Results Of the 32136 samples,226 cases were IgM positive and 452 cases were IgG positive.The positive samples were then tested by nucleic acid test.Combined with the diagnostic criteria,clinical manifestations and epidemiological investigation,2 cases were confirmed as positive and the rest were false positive.The false positive rate of IgM antibody was 0.70%(224/32136)and that of IgG antibody was 1.40%(450/32136).There was no significant difference in the false positive rate between male and female(P>0.05).For age groups of≤20,21-30,31-40,41-50,51-60 and>60 years old,coronavirus specific antibody IgM false positive rates were lower than IgG antibody.The rates of false positives in>60 elderly group for IgM and IgG antibody were the highest,compared with other age groups(P<0.05).With the increase of age,IgG antibody also showed a gradually increase for the rate of false positives.False positives in patients with cancer caused by antibodies was the highest.Conclusion Although new crown antibody detection can only serve as an adjunct diagnostic tool in patients with multiple negative nucleic acid tests and clinically symptomatic or radiologically specific changes,it is not suitable for large-scale general population screening.At the same time,it is necessary to effectively identify the influence of interference factors on the detection results and provide help for the diagnosis and treatment of novel cor
作者 金晶 边春红 聂秀娟 潘玥 JIN Jing;BIAN Chunhong;NIE Xiujuan;PAN Yue(Department of Clinical Laboratory, Beijing Haidian Hospital, Beijing 100090, China)
出处 《标记免疫分析与临床》 CAS 2021年第6期1045-1050,共6页 Labeled Immunoassays and Clinical Medicine
关键词 化学发光法 新型冠状病毒 特异性抗体 假阳性 Chemiluminescence method SARA-CoV-2 Specific antibody False positive
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