不同严重急性呼吸综合征冠状病毒2抗体检测试剂盒的诊断应用评价

Evaluation of diagnostic application of different severe acute respiratory syndrome coronavirus 2 specific antibody detection kits

本文评估了6个品牌的严重急性呼吸综合征冠状病毒2(severe acute respiratory syndrome coronavirus 2,SARS-CoV-2)特异性抗体检测试剂盒的性能,以指导临床合理选用。收集2020年1月30日至2020年5月11日期间上海市(复旦大学附属)公共卫生临床中心的住院患者样本资料共245例,其中包括SARS-CoV-2感染确诊患者122例,排除SARS-CoV-2感染的其他疾病患者123例。选用6个品牌的抗体检测试剂盒(3种为胶体金法,3种为化学发光法)检测所有患者的血清样本,同步采用聚合酶链反应(polymerase chain reaction,PCR)检测SARS-CoV-2核酸,统计临床灵敏度、特异性、阴性预测值和阳性预测值等指标,比较各检测方法间的差异。结果显示,各检测试剂盒在临床特异性方面表现相近,但临床灵敏度差异明显,IgG的灵敏度高于IgM。化学发光试剂灵敏度为72.1%~85.2%,整体优于胶体金试剂的47.5%~84.4%。所有试剂检测结果与SARS-CoV-2核酸诊断结果相比均有统计学差异(P<0.05)。SARS-CoV-2抗体的特异性检出率随时间而上升,核酸确诊患者≥16d抗体检出率最高可达96%。结果表明,SARS-CoV-2抗体检测可作为核酸诊断的辅助手段,IgG和IgM联合诊断可提高检测的灵敏度。但是不同试剂盒性能表现有差异,应根据不同临床需求和应用场景选择合适的试剂盒。

To evaluate the performances of severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)specific antibody detection assays from six manufacturers and give directions for clinical application,serum samples from 245 patients(122 SARS-CoV-2 confirmed infection cases and 123 SARS-CoV-2 negative cases)admitted in Shanghai Public Health Clinical Centre from Jan 30th to May 11th 2020 were collected and tested by SARS-CoV-2 antibody detection assays purchased from six manufactures,including 3 uses colloidal gold strips while others are chemiluminescence immunoassays(CLIA).SARS-Cov-2 nucleic acid was detected by PCR Simultaneously.Clinical sensitivity,clinical specificity,PPV,NPV and other parameters were analyzed to evaluate and compare the performances of different assays.Assays had similar performances in terms of clinical specificity,but differ in clinical sensitivity.Compared to IgM detection,IgG detection seems more sensitive.CLIA assays had a sensitivity of 72.1%~85.2%which was superior to that of colloidal gold(47.5%~84.4%).All assays were determined to have statistically significant difference from PCR.The sensitivity of antibody detection increased over time,the sensitivity reached 96%after≥16 days after PCR confirmation.SARS-CoV-2 antibody detection can serve as an auxiliary method to PCR in diagnosis.IgG and IgM joint detection may increase sensitivity in SARS-CoV-2 diagnosis.Performances of different assays varied a lot.Use of assays should depend on clinical requirement and application scenarios.