State Key Laboratory of Food Science and Technology, Jiangnan University, Wuxi, People's Republic of China.
International Joint Research Laboratory for Biointerface and Biodetection, and School of Food Science and Technology, Jiangnan University, Wuxi, People's Republic of China.
J Mater Chem B. 2022 Mar 16;10(11):1786-1794. doi: 10.1039/d1tb02521j.
An epidemic caused by the severe acute respiratory syndrome coronavirus (SARS-CoV-2) spread globally in just a few months. To prevent the further spread of the virus, millions of people around the world have been vaccinated for COVID-19. Although the plaque reduction neutralization test (PRNT) has become the gold standard method for determining neutralizing antibodies, this method has many limitations; therefore, there remains an urgent need for a quick and accurate technique to evaluate the immune efficacy of COVID-19 vaccines. Here, after the recombinant expression of the SARS-CoV-2 spike protein receptor binding domain (S-RBD), we established a colloidal gold immunochromatographic assay (GICA) based on the principle of a double antigen sandwich for the detection of total antibodies in sera. Under the developed conditions, the GICA was capable of the rapid detection of SARS-CoV-2 total antibodies within 15 min. In addition, the anti-S-RBD antibodies measured by the GICA had a good correlation with the results measured by ELISA, indicating that the GICA may be used as a rapid tool for the detection of neutralizing antibodies derived from SARS-CoV-2 infection. Clinical detection was performed using serum samples obtained from 40 subjects who had received their two doses of the COVID-19 vaccine and 20 unvaccinated serum samples. We found that our method had high sensitivity and specificity; therefore, our convenient and rapid GICA method could preliminarily evaluate the protection rate and effectiveness of vaccines by monitoring total antibody levels.
一种由严重急性呼吸系统综合症冠状病毒 2 型（SARS-CoV-2）引起的传染病在短短几个月内就在全球范围内传播开来。为了防止病毒进一步传播，全世界数百万人已经接种了 COVID-19 疫苗。虽然病毒中和抗体滴度测定（PRNT）已成为确定中和抗体的金标准方法，但该方法存在许多局限性；因此，仍然迫切需要一种快速准确的技术来评估 COVID-19 疫苗的免疫效果。在这里，在 SARS-CoV-2 刺突蛋白受体结合域（S-RBD）的重组表达之后，我们根据双抗原夹心原理建立了一种胶体金免疫层析测定法（GICA），用于检测血清中的总抗体。在开发的条件下，GICA 能够在 15 分钟内快速检测 SARS-CoV-2 总抗体。此外，GICA 测量的抗 S-RBD 抗体与 ELISA 测量的结果具有良好的相关性，表明 GICA 可作为检测源自 SARS-CoV-2 感染的中和抗体的快速工具。使用从已接种两剂 COVID-19 疫苗的 40 名受试者和 20 名未接种疫苗的血清样本获得的血清样本进行临床检测。我们发现，我们的方法具有很高的灵敏度和特异性；因此，我们方便快捷的 GICA 方法可以通过监测总抗体水平初步评估疫苗的保护率和有效性。
