Department of Laboratory Medicine, Keio University School of Medicine, Tokyo, Japan.
Department of Infectious Diseases, Keio University School of Medicine, Tokyo, Japan.
Ann Clin Biochem. 2021 May;58(3):174-180. doi: 10.1177/0004563220984827. Epub 2021 Jan 7.
The usability of laboratory tests related to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is critically important for the world undergoing the COVID-19 pandemic. The present study aimed to assess the diagnostic usability of rapid tests for the detection of antibody against SARS-CoV-2 through comparison of their results with the results of reverse transcription polymerase chain reaction (RT-PCR) test for the detection of SARS-CoV-2 genomic RNA and with the results of a quantitative test for antibody detection.
Serum samples were collected from 18 patients undergoing RT-PCR testing for SARS-CoV-2. Twelve patients were RT-PCR positive while six were negative. A quantitative test based on chemiluminescent immunoassay and three rapid tests based on immunochromatography were performed to detect anti-SARS-CoV-2 IgG and IgM.
All the antibody tests exhibited poor sensitivity at the timing of initial RT-PCR diagnosis. IgG responses occurring prior to or simultaneously with IgM responses were observed through not only the quantitative test but also the three rapid tests. Based on concordance with the quantitative test results, the large variance among the three rapid tests was revealed.
All antibody tests were unsatisfactory to replace RT-PCR for the early diagnosis of COVID-19. Rapid antibody tests as well as a quantitative antibody test were useful in the assessment of immune responses in COVID-19. The obvious variance among the three rapid tests suggested limited accuracy and difficult standardization. Diagnostic usability of rapid antibody tests for COVID-19 should be investigated rigorously.
与严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）相关的实验室检测的可用性对于正在经历 COVID-19 大流行的世界至关重要。本研究旨在通过比较快速检测抗体对 SARS-CoV-2 的检测结果与 RT-PCR 检测 SARS-CoV-2 基因组 RNA 的检测结果以及与定量抗体检测的检测结果，评估快速检测的诊断可用性。
收集了 18 例接受 SARS-CoV-2 RT-PCR 检测的患者的血清样本。12 例患者 RT-PCR 阳性，6 例患者 RT-PCR 阴性。进行了基于化学发光免疫分析的定量检测和基于免疫层析的三种快速检测，以检测抗 SARS-CoV-2 IgG 和 IgM。
所有抗体检测在初始 RT-PCR 诊断时的敏感性均较差。不仅通过定量检测，而且通过三种快速检测都观察到了在 IgM 反应之前或同时发生的 IgG 反应。基于与定量检测结果的一致性，揭示了三种快速检测之间的较大差异。
所有抗体检测均不能替代 RT-PCR 进行 COVID-19 的早期诊断。快速抗体检测和定量抗体检测均有助于评估 COVID-19 中的免疫反应。三种快速检测之间的明显差异表明准确性有限且标准化困难。应严格评估 COVID-19 快速抗体检测的诊断可用性。
