摘要
目的探讨酶联免疫吸附试验(enzyme-linked immunosorbent assay,ELISA)法与胶体金法检测新型冠状病毒(2019 novel coronavirus,2019-nCoV)血清抗体的诊断价值。方法选取湖南省新型冠状病毒肺炎(简称新冠肺炎,COVID-19)确诊病例88例作为病例组,51例核酸检测阴性者作为对照组。采集研究对象血标本,采用ELISA法和胶体金法对所采集标本进行抗体检测,比较两种方法检出率差异;以核酸检测结果作为金标准,评估ELISA法和胶体金法的检验效能。结果本研究结果显示,ELISA法和胶体金法检测2019-nCoVIgM检出率均为20.97%,2019-nCoVIgG检出率分别为43.55%、35.48%。不同采样时间ELISA法和胶体金法检测2019-nCoV IgM检出率差异无统计学意义(均P>0.05)。发病-采样时间间隔≤7 d时,两种检测方法对2019-nCoV IgG检测结果差异有统计学意义(χ2=5.55,P=0.02),ELISA检出率(26.47%)高于胶体金法(5.71%)。通过对比不同发病-采样间隔发现,无论是ELISA法还是胶体金法,在一定时间内,间隔时间越长,2019-nCoV IgM和IgG检出率越高。以核酸检测结果为金标准,检测IgG和IgM时,ELISA法和胶体金法的灵敏度、特异度、阳性预测值和阴性预测值差异均无统计学意义。结论 ELISA法与胶体金法检验效能相当,两者特异度高,但灵敏度上都存在局限性,不建议用于筛查,可以作为确诊的补充诊断手段或应用于聚集性疫情溯源。
Objective To explore the diagnostic value of enzyme-linked immunosorbent assay(ELISA)and colloidal gold method in detecting serum antibodies of 2019 novel coronavirus(2019-nCoV).Methods Eighty-eight confirmed cases of 2019-nCoV in Hunan province were selected as the case group,while 51 cases with negative nucleic acid test served as the control group.Blood samples of the research subjects were collected,and colloidal gold and ELISA methods were used to detect antibodies of the collected samples.The differences in the detection rates of the two methods were compared.The nucleic acid test results were used as the gold standard to evaluate the test efficacy of ELISA and colloidal gold methods.Results The results of this study showed that the positive rates of 2019-nCoV IgM detected by ELISA and colloidal gold method were both 20.97%,while the positive rates of 2019-nCoV IgG detection were 43.55%and 35.48%,respectively.Among the samples with different onset-sampling intervals,there was no statistically significant difference in the detection rates of 2019-nCoV IgM detected by ELISA and colloidal gold method(both P>0.05).When the onset-sampling interval was less than or equal to 7 days,the difference in the 2019-nC oV IgG test results of the two detection methods was statistically significant(χ2=5.55,P=0.02),and the detection rate of ELISA(26.47%)was higher than that of colloidal gold method(5.71%).A comparison of different onset-sampling intervals showed that the longer the interval,the higher the positive rates of 2019-nC oV IgM and IgG detected not only by ELISA but also by colloidal gold method.With the nucleic acid test results as the gold standard,no statistically significant differences were found in the sensitivity,specificity,positive and negative predictive values between ELISA and colloidal gold method when detecting IgG and IgM.Conclusions The detection efficiency of ELISA is equivalent to that of colloidal gold method,and both have high specificity and limitations in sensitivity.Neither method is recommended for screening,but they can be used as a supplementary diagnostic method for confirmatory diagnosis or to trace the source of clustered epidemics.
作者
李芳彩
戴志辉
贺子翔
黄一伟
王娟
何方玲
周帅锋
欧新华
李广兵
范乐君
湛志飞
LI Fang-cai;DAI Zhi-hui;HE Zi-xiang;HUANG Yi-wei;WANG Juan;HE Fang-ling;ZHOU Shuai-feng;OU Xin-hua;LI Guang-bing;FAN Le-jun;ZHAN Zhi-fei(Hunan Provincial Center for Disease Control and Prevention,Changsha,Hunan 410005,China;Changsha Municipal Center for Disease Control and Prevention,Changsha,Hunan 410000,China;Shaoyang Municipal Center for Disease Control and Prevention,Shaoyang,Hunan 422000,China;Huaihua Municipal Center for Disease Control and Prevention,Huaihuua,Hunan 418000,China)
出处
《实用预防医学》
CAS
2020年第7期780-783,共4页
Practical Preventive Medicine
基金
湖南省重点领域研发计划社会发展领域重点研究项目(编号:2020SK3012)
科技部十三五科技重大专项课题(编号:2018ZX10713002)。
关键词
新型冠状病毒
ELISA法
胶体金法
抗体
2019 novel coronavirus
enzyme-linked immunosorbent assay
colloidal gold method
antibody
