Biosensor Research Center, Endocrinology and Metabolism Molecular-Cellular Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
Monoclon Antib Immunodiagn Immunother. 2021 Oct;40(5):210-218. doi: 10.1089/mab.2021.0027.
The novel coronavirus disease (COVID-19), known as severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), exhibits a strong human-to-human transmission infectivity and could cause acute respiratory infections. Therefore, simple and rapid serological testing is urgently needed to recognize positive cases. In this study, a point-of-care serological test based on lateral flow immunoassay (LFIA) was developed and its application for the simultaneous detection of IgM/IgG antibodies against SARS-CoV-2 was evaluated. The recombinant SARS-CoV-2 antigens were conjugated to the produced colloidal gold nanoparticles and used as the detection reagent. This test required only 10-15 minutes to achieve simultaneous qualitative detection of IgM/IgG antibodies specific to SARS-CoV-2 in 20 μL of serum or plasma samples. The clinical performance and reliability of the assay were evaluated by performing the test with 60 samples and comparing the results of these tests with those obtained via real-time polymerase chain reaction. The sensitivity and specificity of our assay were defined to be 90% and 96.6%, respectively. The presented LFIA was sufficiently sensitive and accurate to be used for the rapid diagnosis of coronavirus disease 2019 in laboratories or in patient care settings, particularly in emergency conditions, in which many samples require to be evaluated on time.
新型冠状病毒病（COVID-19），又称严重急性呼吸综合征冠状病毒-2（SARS-CoV-2），具有很强的人际传播感染力，可引起急性呼吸道感染。因此，急需简单快速的血清学检测来识别阳性病例。在本研究中，开发了一种基于侧向流动免疫分析（LFIA）的即时检测血清学测试，并评估了其用于同时检测 SARS-CoV-2 的 IgM/IgG 抗体的应用。将重组 SARS-CoV-2 抗原与制备的胶体金纳米颗粒偶联，用作检测试剂。该测试仅需 10-15 分钟，即可在 20μL 的血清或血浆样本中同时定性检测针对 SARS-CoV-2 的 IgM/IgG 抗体。通过对 60 个样本进行测试，评估了该检测方法的临床性能和可靠性，并将这些测试的结果与实时聚合酶链反应的结果进行了比较。该检测方法的灵敏度和特异性分别定义为 90%和 96.6%。该 LFIA 具有足够的灵敏度和准确性，可用于实验室或患者护理环境中 COVID-19 的快速诊断，特别是在紧急情况下，需要及时评估许多样本。
