在实际医院环境中使用快速检测试剂盒评估针对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）刺突蛋白的免疫球蛋白G和免疫球蛋白M抗体检测性能
Evaluation of Performance of Detection of Immunoglobulin G and Immunoglobulin M Antibody Against Spike Protein of SARS-CoV-2 by a Rapid Kit in a Real-Life Hospital Setting.
作者信息
Irungbam Monica, Chitkara Anubhuti, Singh Vijay Kumar, Sonkar Subash Chandra, Dubey Abhisek, Bansal Aastha, Shrivastava Ritika, Goswami Binita, Manchanda Vikas, Saxena Sonal, Saxena Ritu, Garg Sandeep, Husain Farah, Talukdar Tanmay, Kumar Dinesh, Koner Bidhan Chandra
机构信息
Department of Biochemistry, Maulana Azad Medical College and Associated Hospitals, New Delhi, India.
Multidisciplinary Research Unit (MRU), Maulana Azad Medical College and Associated Hospitals, New Delhi, India.
出版信息
Front Microbiol. 2022 Apr 25;13:802292. doi: 10.3389/fmicb.2022.802292. eCollection 2022.
BACKGROUND
Antibody testing is often used for serosurveillance of coronavirus disease 2019 (COVID-19). Enzyme-linked immunosorbent assay and chemiluminescence-based antibody tests are quite sensitive and specific for such serological testing. Rapid antibody tests against different antigens are developed and effectively used for this purpose. However, their diagnostic efficiency, especially in real-life hospital setting, needs to be evaluated. Thus, the present study was conducted in a dedicated COVID-19 hospital in New Delhi, India, to evaluate the diagnostic efficacy of a rapid antibody kit against the receptor-binding domain (RBD) of the spike protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
METHODS
Sixty COVID-19 confirmed cases by reverse transcriptase-polymerase chain reaction (RT-PCR) were recruited and categorized as early, intermediate, and late cases based on the days passed after their first RT-PCR-positive test report, with 20 subjects in each category. Twenty samples from pre-COVID era and 20 RT-PCR-negative collected during the study period were taken as controls. immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies against the RBD of the spike (S) protein of SARS-CoV-2 virus were detected by rapid antibody test and compared with the total antibody against the nucleocapsid (N) antigen of SARS-CoV-2 by electrochemiluminescence-based immunoassay (ECLIA).
RESULTS
The detection of IgM against the RBD of the spike protein by rapid kit was less sensitive and less specific for the diagnosis of SARS-CoV-2 infection. However, diagnostic efficacy of IgG by rapid kit was highly sensitive and specific when compared with the total antibody against N antigen measured by ECLIA.
CONCLUSION
It can be concluded that detection of IgM against the RBD of S protein by rapid kit is less effective, but IgG detection can be used as an effective diagnostic tool for SARS-CoV-2 infection in real-life hospital setting.
背景
抗体检测常用于2019冠状病毒病（COVID-19）的血清学监测。酶联免疫吸附测定和基于化学发光的抗体检测对于此类血清学检测相当敏感且特异。针对不同抗原的快速抗体检测已被开发并有效地用于此目的。然而，它们的诊断效率，尤其是在实际医院环境中，需要进行评估。因此，本研究在印度新德里一家专门的COVID-19医院进行，以评估一种针对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）刺突蛋白受体结合域（RBD）的快速抗体检测试剂盒的诊断效力。
方法
招募了60例经逆转录聚合酶链反应（RT-PCR）确诊的COVID-19病例，并根据首次RT-PCR阳性检测报告后的天数分为早期、中期和晚期病例，每组20例。将20份COVID-19疫情前的样本和研究期间收集的20份RT-PCR阴性样本作为对照。通过快速抗体检测检测针对SARS-CoV-2病毒刺突（S）蛋白RBD的免疫球蛋白M（IgM）和免疫球蛋白G（IgG）抗体，并通过基于电化学发光的免疫测定（ECLIA）与针对SARS-CoV-2核衣壳（N）抗原的总抗体进行比较。
结果
快速检测试剂盒检测针对刺突蛋白RBD的IgM对SARS-CoV-2感染的诊断敏感性和特异性较低。然而，与通过ECLIA测量的针对N抗原的总抗体相比，快速检测试剂盒检测IgG的诊断效力具有高度敏感性和特异性。
结论
可以得出结论，快速检测试剂盒检测针对S蛋白RBD的IgM效果较差，但IgG检测可作为实际医院环境中SARS-CoV-2感染的有效诊断工具。
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