新型冠状病毒ELISA试剂盒灵敏度和特异度评价

Evaluation of the sensitivity and specificity of ELISA kits for the SARS-CoV-2 diagnosis

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.