Jang Woong Sik, Jee Hyunseul, Lee Joon Min, Lim Chae Seung, Kim Jeeyong
Emergency Medicine, College of Medicine, Korea University Guro Hospital, Seoul 08308, Republic of Korea.
Departments of Laboratory Medicine, College of Medicine, Korea University, Seoul 02841, Republic of Korea.
Diagnostics (Basel). 2023 Mar 15;13(6):1118. doi: 10.3390/diagnostics13061118.
Coronavirus disease (COVID-19) caused by SARS-CoV-2 infection has been a global pandemic for more than two years, and it is important to quickly and accurately diagnose and isolate patients with SARS-CoV-2 infection. The BZ COVID-19 NALF Assay could sensitively detect SARS-CoV-2 from a nasopharyngeal swab because it adopts both a loop-mediated isothermal amplification and lateral flow immunochromatography technology. In this study, a total of 389 nasopharyngeal swab samples, of which 182 were SARS-CoV-2 PCR positive and 207 were negative samples, were recruited. Compared to the Allplex™ SARS-CoV-2 Assay, the BZ COVID-19 NALF Assay showed 95.05% sensitivity and 99.03% specificity for detecting SARS-CoV-2. The concordance rate between the BZ COVID-19 NALF Assay and Allplex™ SARS-CoV-2 Assay was 97.69%. The turnaround time of the BZ COVID-19 NALF Assay is only about 40~55 min. The BZ COVID-19 NALF Assay is an accurate, easy, and quick molecular diagnostic test compared to the conventional PCR test for detection of SARS-CoV-2. In addition, the BZ COVID-19 NALF Assay is thought to be very useful in small size medical facilities or developing countries where it is difficult to operate a clinical laboratory.
由严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染引起的冠状病毒病（COVID-19）已成为全球性大流行两年多了，快速准确地诊断和隔离SARS-CoV-2感染患者非常重要。BZ COVID-19 NALF检测法可灵敏地从鼻咽拭子中检测出SARS-CoV-2，因为它采用了环介导等温扩增技术和侧向流动免疫层析技术。在本研究中，共收集了389份鼻咽拭子样本，其中182份为SARS-CoV-2 PCR阳性样本，207份为阴性样本。与Allplex™ SARS-CoV-2检测法相比，BZ COVID-19 NALF检测法检测SARS-CoV-2的灵敏度为95.05%，特异性为99.03%。BZ COVID-19 NALF检测法与Allplex™ SARS-CoV-2检测法的一致性率为97.69%。BZ COVID-19 NALF检测法的周转时间仅约40~55分钟。与用于检测SARS-CoV-2的传统PCR检测法相比，BZ COVID-19 NALF检测法是一种准确、简便且快速的分子诊断检测方法。此外，BZ COVID-19 NALF检测法被认为在难以运营临床实验室的小型医疗设施或发展中国家非常有用。
