Lee Nan Young, Ham Ji Yeon, Hwang Narae, Song Kyung Eun
Clin Lab. 2023 Jan 1;69(1). doi: 10.7754/Clin.Lab.2022.220421.
As COVID-19 has spread rapidly around the world, it has become essential to detect the virus quickly and accurately for disease prevention and control. Therefore, in response to the COVID-19 pandemic, the need for rapid serological point-of-care test has increased. Recently, many antibody tests have been developed to detect IgM and/or IgG to SARS-CoV-2 in human blood. The authors conducted a prospective study to evaluate the performance of a rapid chromatographic immunoassay and a fluorescent immunoassay for the qualitative detection of specific antibodies, IgM and IgG to SARS-CoV-2 in capillary blood samples, compared to the real-time RT-PCR.
The subjects included 70 patients who were confirmed positive by real-time RT-PCR and 70 people who were negative. STANDARD Q COVID-19 IgM/IgG Plus Test (chromatographic immunoassay) and Fluorescent immunoassay for IgM and IgG to SARS-CoV-2 (fluorescent immunoassay) were performed using capillary blood samples. Based on the results of real-time RT-PCR assay, clinical sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of two rapid tests were investigated. And the agreement rate between two rapid tests was also presented.
Sensitivity, specificity, PPV and NPV of the chromatographic immunoassay were 82.9%, 98.6%, 98.3%, and 85.2%, respectively. At more than 7 days after the onset of symptoms, sensitivity increased to 87.3%. Sensitivity, specificity, PPV, and NPV were 81.4%, 100.0%, 100.0%, and 84.3%, respectively, for the fluorescent immunoassay. At more than 7 days after the onset of symptoms, sensitivity increased to 85.7%. The agreement rate of the two tests was 97.1%.
STANDARD Q COVID-19 IgM/IgG Plus Test and STANDARD F COVID-19 IgM/IgG Combo FIA turned out very specific and sensitive enough to detect individuals infected to SARS-CoV-2. Also, these tests were simple, fast, visually interpretable, and required a small amount of capillary whole blood.
随着新冠病毒病（COVID-19）在全球迅速传播，为疾病预防和控制而快速、准确地检测该病毒变得至关重要。因此，为应对COVID-19大流行，对快速血清学即时检测的需求增加。最近，已开发出许多抗体检测方法来检测人血液中针对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的IgM和/或IgG。作者进行了一项前瞻性研究，以评估一种快速色谱免疫分析法和一种荧光免疫分析法在定性检测毛细血管血样中针对SARS-CoV-2的特异性抗体IgM和IgG方面的性能，并与实时逆转录聚合酶链反应（RT-PCR）进行比较。
研究对象包括70例经实时RT-PCR确诊为阳性的患者和70例阴性者。使用毛细血管血样进行标准Q COVID-19 IgM/IgG Plus检测（色谱免疫分析法）以及针对SARS-CoV-2的IgM和IgG荧光免疫检测（荧光免疫分析法）。基于实时RT-PCR检测结果，研究两种快速检测方法的临床敏感性、特异性、阳性预测值（PPV）和阴性预测值（NPV）。同时还给出了两种快速检测方法之间的符合率。
色谱免疫分析法的敏感性、特异性、PPV和NPV分别为82.9%、98.6%、98.3%和85.2%。在症状出现7天以上时，敏感性增至87.3%。荧光免疫分析法的敏感性、特异性、PPV和NPV分别为81.4%、100.0%、100.0%和84.3%。在症状出现7天以上时，敏感性增至85.7%。两种检测方法的符合率为97.1%。
标准Q COVID-19 IgM/IgG Plus检测和标准F COVID-19 IgM/IgG组合荧光免疫分析结果显示，它们在检测感染SARS-CoV-2的个体方面具有足够的特异性和敏感性。此外，这些检测方法操作简单、快速、结果可直观判读，且只需少量毛细血管全血。
