Development and clinical application of a rapid IgM-IgG combined antibody test for SARS-CoV-2 infection diagnosis
Development and clinical application of a rapid IgM-IgG combined antibody test for SARS-CoV-2 infection diagnosis
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DOI：
10.1002/jmv.25727
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发表时间：
2020-04-13
影响因子：
12.7
通讯作者：
Ye, Feng
中科院分区：
文献类型：
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作者：
Li, Zhengtu;Yi, Yongxiang;Ye, Feng
新型冠状病毒病（COVID-19）的爆发迅速蔓延到中国各地和其他20多个国家。尽管病毒（严重急性呼吸综合征冠状病毒[SARS-Cov-2]）核酸实时聚合酶链反应（PCR）检测已成为诊断SARS-CoV-2感染的标准方法，但这些实时PCR检测试剂盒存在诸多局限性。此外，还报告了高假阴性率。目前迫切需要一种准确、快速的检测方法，快速识别大量感染患者和无症状携带者，以防止病毒传播，确保患者得到及时治疗。我们开发了一种快速、简单的床旁侧流免疫测定法，可以在15分钟内同时检测人血液中抗SARS-CoV-2病毒的免疫球蛋白M（IgM）和IgG抗体，可以检测不同感染阶段的患者。使用该检测试剂盒，我们进行了临床研究，以验证其临床功效用途。该检测的临床检测灵敏度和特异性是使用从8个不同临床地点收集的397名PCR确认的COVID-19患者和128名阴性患者的血液样本进行测量的。总的检测灵敏度为88.66%，特异度为90.63%。此外，我们评估了从不同类型的静脉和手指针刺血液样本获得的临床诊断结果。结果表明，手指血、血清和静脉血血浆样品的检测结果具有很好的一致性。与单一IgM或IgG检测相比，IgM-IgG联合检测具有更好的实用性和灵敏度。它可用于在医院、诊所和检测实验室快速筛查有症状或无症状的SARS-CoV-2携带者。
The outbreak of the novel coronavirus disease (COVID-19) quickly spread all over China and to more than 20 other countries. Although the virus (severe acute respiratory syndrome coronavirus [SARS-Cov-2]) nucleic acid real-time polymerase chain reaction (PCR) test has become the standard method for diagnosis of SARS-CoV-2 infection, these real-time PCR test kits have many limitations. In addition, high false-negative rates were reported. There is an urgent need for an accurate and rapid test method to quickly identify a large number of infected patients and asymptomatic carriers to prevent virus transmission and assure timely treatment of patients. We have developed a rapid and simple point-of-care lateral flow immunoassay that can detect immunoglobulin M (IgM) and IgG antibodies simultaneously against SARS-CoV-2 virus in human blood within 15 minutes which can detect patients at different infection stages. With this test kit, we carried out clinical studies to validate its clinical efficacy uses. The clinical detection sensitivity and specificity of this test were measured using blood samples collected from 397 PCR confirmed COVID-19 patients and 128 negative patients at eight different clinical sites. The overall testing sensitivity was 88.66% and specificity was 90.63%. In addition, we evaluated clinical diagnosis results obtained from different types of venous and fingerstick blood samples. The results indicated great detection consistency among samples from fingerstick blood, serum and plasma of venous blood. The IgM-IgG combined assay has better utility and sensitivity compared with a single IgM or IgG test. It can be used for the rapid screening of SARS-CoV-2 carriers, symptomatic or asymptomatic, in hospitals, clinics, and test laboratories.