Lee Ae Sol, Kim Su Min, Kim Kyeong Rok, Park Chulmin, Lee Dong-Gun, Heo Hye Ryoung, Cha Hyung Joon, Kim Chang Sup
Graduate School of Biochemistry, Yeungnam University, Gyeongsan 38541, Republic of Korea.
Vaccine Bio Research Institute, College of Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul 06591, Republic of Korea.
Sens Actuators B Chem. 2023 Mar 15;379:133245. doi: 10.1016/j.snb.2022.133245. Epub 2022 Dec 26.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19). The high human-to-human transmission and rapid evolution of SARS-CoV-2 have resulted in a worldwide pandemic. To contain SARS-CoV-2, it is essential to efficiently control the transmission of the virus through the early diagnosis of infected individuals, including asymptomatic people. Therefore, a rapid and accurate assay is vital for the early diagnosis of SARS-CoV-2 in suspected individuals. In this study, we developed a colorimetric lateral flow immunoassay (LFIA) in which a CBP31-BC linker was used to immobilize antibodies on a cellulose membrane in an oriented manner. The developed LFIA enabled sensitive detection of cultured SARS-CoV-2 in 15 min with a detection limit of 5 × 10 copies/mL. The clinical performance of the LFIA for detecting SARS-CoV-2 was evaluated using 19 clinical samples validated by reverse transcription-polymerase chain reaction (RT-PCR). The LFIA detected all the positive and negative samples accurately, corresponding to 100% accuracy. Importantly, patient samples with low viral loads were accurately identified. Thus, the proposed method can provide a useful platform for rapid and accurate point-of-care testing of SARS-CoV-2 in infected individuals to efficiently control the COVID-19 pandemic.
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）引发了2019冠状病毒病（COVID-19）。SARS-CoV-2的高人际传播率和快速进化导致了全球大流行。为了控制SARS-CoV-2的传播，通过对包括无症状感染者在内的受感染个体进行早期诊断来有效控制病毒传播至关重要。因此，一种快速准确的检测方法对于疑似个体中SARS-CoV-2的早期诊断至关重要。在本研究中，我们开发了一种比色侧向流动免疫分析（LFIA），其中使用CBP31-BC连接子以定向方式将抗体固定在纤维素膜上。所开发的LFIA能够在15分钟内灵敏检测培养的SARS-CoV-2，检测限为5×10拷贝/毫升。使用经逆转录聚合酶链反应（RT-PCR）验证的19份临床样本评估了LFIA检测SARS-CoV-2的临床性能。LFIA准确检测了所有阳性和阴性样本，准确率达100%。重要的是，低病毒载量的患者样本也被准确识别。因此，所提出的方法可为感染个体中SARS-CoV-2的快速准确即时检测提供一个有用的平台，以有效控制COVID-19大流行。
