新型冠状病毒特异性抗体检测假阳性分析  

Analysis for false positive results of specific antibody to SARS-CoV-2

作　　者：巢蓓 范小杰 姚玉华[1] 周寅[1] 史梅[1] 彭阳[1] 周围 马锦洪[1] 史伟峰[1] CHAO Bei;FAN Xiaojie;YAO Yuhua;ZHOU Yin;SHI Mei;PENG Yang;ZHOU Wei;MA Jinhong;SHI Weifeng(The Third affiliated Hospital of Soochow University,Changzhou 213003,Jiangsu,China)

机构地区：[1]苏州大学附属第三医院检验科,江苏常州213003

出　　处：《临床检验杂志》2020年第8期574-577,共4页Chinese Journal of Clinical Laboratory Science

基　　金：国家自然科学基金(81572052);江苏省自然科学基金(BK20151178)。

摘　　要：目的探讨血清新型冠状病毒(SARS-CoV-2)特异性抗体检测的价值及其临床应用。方法采集2020年3月17日至4月20日入院患者4 825例血液标本。化学发光法检测血清SARS-CoV-2 Ig M和Ig G抗体,荧光定量PCR检测抗体阳性患者咽拭子标本核酸。结果 4 825例血清标本中11例SARS-CoV-2 Ig M阳性,111例SARS-CoV-2 Ig G抗体阳性,经SARS-CoV-2核酸检测、CT检查及流行病学特点判为假阳性,Ig M和Ig G抗体总的假阳性率分别为0.23%(11/4 825)、2.30%(111/4 825)。1 471例<50岁患者中Ig G抗体假阳性率为0.75%(11/1 471),3 354例>50岁患者中Ig G抗体假阳性率为2.98%(100/3 354),两组间差异有统计学意义(P<0.001)。111例Ig G假阳性病例中,以肿瘤(57.66%)、血液病(10.81%)等患者居多。结论SARS-CoV-2 Ig M和Ig G抗体检测存在较高的假阳性,须与核酸检测协同使用,并不适用于复工复产复学人群或一般人群筛查。Objective To investigate the value and clinical application of specific antibody to severe acute respiratory syndrome coronavirus 2( SARS-CoV-2) in serum. Methods During the period from Mar 17 to Apr 20,2020,a total of 4 825 blood samples from hospitalized patients were collected. The Ig M and Ig G antibodies specific to SARS-CoV-2 were detected by chemiluminescence. The fluorescence quantitative PCR for nucleic acid were further performed to detect the throat swabs of the patients with positive antibodies.Results Among the 4 825 serum samples,11 were found to be positive Ig M and 111 were positive Ig G antibodies respectively,however,all of these samples were conformed to be false positive antibodies by SARS-CoV-2 nucleic acid detection,chest CT and epidemiological characteristics,thus the total false positive rates of Ig M and Ig G antibodies were 0.23%( 11/4 825) and 2.30%( 111/4 825),respectively. Grouped by age,the false positive rate of Ig G antibody was 0.75%( 11/1 471) in the patients below 50 years old,while it was 2.98% in( 100/3 354) in the patients more than 50 years old. There was significant difference between the two groups with different ages( P<0.001). Among the 111 cases with false positive Ig G,the patients complicated tumors and blood diseases accounted for57.66 % and 10.81%,respectively. Conclusion Due to the high false positive rate of Ig M and Ig G antibody to SARS-CoV-2,the detection of nucleic acid should be performed simultaneously. Therefore,the detection of anti-SARS-CoV-2 antibodies should not be suitable for the people returning to work,manufacture,school or screening for general population.

关 键 词：新型冠状病毒 特异性抗体 假阳性 

分 类 号：R446.5[医药卫生—诊断学]