李德昌,张明霞,林大川,等.新型冠状病毒ELISA试剂盒灵敏度和特异度评价[J].深圳大学学报理工版,2020,37(3):224-226.[doi:10.3724/SP.J.1249.2020.03224]
LI Dechang,ZHANG Mingxia,LIN Dachuan,et al.Evaluation of the sensitivity and specificity of ELISA kits for the SARS-CoV-2 diagnosis[J].Journal of Shenzhen University Science and Engineering,2020,37(3):224-226.[doi:10.3724/SP.J.1249.2020.03224]
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新型冠状病毒ELISA试剂盒灵敏度和特异度评价
李德昌1,2,张明霞3,林大川2,4,胡云龙2,4,温志华1,2,刘圣泽1,徐羽中5,黄开松4,张 政3,陈心春2,4

1)粤北第二人民医院检验科,广东韶关 512000; 2 )深圳大学医学部-粤北第二人民医院联合实验室,广东深圳 518066; 3)深圳市第三人民医院国家感染性疾病临床研究中心,广东深圳 518112; 4)深圳大学医学部基础医学院,广东深圳 518066; 5)深圳市宝安区人民医院检验科,广东深圳 518100

分子生物学; 免疫学; 新型冠状病毒; 新型冠状病毒肺炎; 酶联免疫; 临床检测

Evaluation of the sensitivity and specificity of ELISA kits for the SARS-CoV-2 diagnosis
LI Dechang1, 2, ZHANG Mingxia3, LIN Dachuan2, 4, HU Yunlong2, 4, WEN Zhihua1, 2, LIU Shengze1, XU Yuzhong5, HUANG Kaisong4, ZHANG Zheng3, and CHEN Xinchun2, 4

1)Department of Clinical Lab, Guangdong North Second Peoples Hospital, Shaoguan 512000, Guangdong Province, P.R.China 2)Shenzhen University Medical School and Guangdong North Second Peoples Hospital Joint Laboratory, Shenzhen 518066, Guangdong Province, P.R.China 3)National Clinical Research Center for Infectious Diseases,Shenzhen Third Peoples Hospital, Shenzhen 518112, Guangdong Province, P.R.China 4)School of Basic Medical Science, Shenzhen University, Shenzhen 518066, Guangdong Province, P.R.China 5)Shenzhen Baoan Peoples Hospital, Department of Clinical Lab, Shenzhen 518100, Guangdong Province, P.R.China

molecular biology; immunology; severe acute respiratory syndrome coronavirus 2(SARS-CoV-2); coronavirus disease 2019(COVID-19); enzyme-linked immunosorbent assay(ELISA); clinical diagnosis

DOI: 10.3724/SP.J.1249.2020.03224

备注

探针反转录聚合酶链反应(reverse transcription-polymerase chain reaction, RT-PCR)方法对呼吸道样品检测灵敏度有限,血清学检测新型冠状病毒抗体逐渐被用作新型冠状病毒核酸检测的辅助工具.本研究利用10名健康者、46名结核病患者及57例确诊新型冠状病毒感染者的血清,对两种新冠病毒IgM酶联免疫检测试剂盒进行评估.结果显示,北京酶联免疫吸附测定(enzyme-linked immunosorbent assay, ELISA)试剂盒对新冠病毒检测的灵敏度和特异度达到87.7%和83.9%,检测效果较好; 珠海ELISA试剂盒对新冠病毒检测的灵敏度和特异度分别为70.1%和89.2%.分析ELISA检测结果与患者发病时间发现,新冠抗体IgM的检测阳性率在发病时间超过14 d的患者群体中,高于发病时间为0～14 d的群体.实验结果证明,新型冠状病毒抗体IgM检测可用于临床新型冠状病毒的诊断,但也显示两种新型冠状病毒抗体检测酶联免疫试剂盒在灵敏度和特异度方面存在一定的差异.

Serological method has been used as an auxiliary tool in the clinical severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)diagnosis due to the low sensitivity of reverse transcription-polymerase chain reaction(RT-PCR)method for respiratory specimens. The serums from 57 confirmed COVID-19 patients, 10 healthy cohorts and 46 tuberculosis patients were employed to determine the sensitivity and specificity of two commercially available enzyme linked immunosorbent(ELISA)kits in their detections of SARS-CoV-2. The sensitivity and specificity of ELISA kit from Beijing company can reach 87.8% and 83.9%, respectively, suggesting a high practical application value. In contrast, the ELISA kit from Zhuhai shows a lower sensitivity(70.1%)but a slightly higher specificity(89.2%). Moreover, a higher detection rate of SARS-CoV-2 IgM is observed in patients that have a longer duration of disease(more than 14 d after onset)than that of people presenting clinical symptoms less than 14 d. Collectively, these results prove the feasibility of SARS-CoV-2 IgM detections by ELISA in the clinical SARS-CoV-2 diagnosis, although these commercially available ELISA kits show different capacities in their diagnosis.

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