Szekely Jidapa, Mongkolprasert Jenureeyah, Jeayodae Nitikorn, Senorit Chadarat, Chaimuti Panuttha, Swangphon Piyawut, Nanakorn Natthaphon, Nualnoi Teerapat, Wongwitwichot Paweena, Pengsakul Theerakamol
Faculty of Medical Technology, Prince of Songkla University, Hat Yai, Songkhla 90110, Thailand.
Kestrel Bio Sciences Thailand Co., Ltd., Klong Luang, Pathumthani 12120, Thailand.
Diagnostics (Basel). 2022 Feb 2;12(2):381. doi: 10.3390/diagnostics12020381.
The antigen rapid diagnostic test (Ag-RDT) is a useful diagnostic tool for the detection and management of COVID-19 spread. Global SARS-CoV-2 variant outbreaks have highlighted the need for a test capable of detecting SARS-CoV-2 variants with high sensitivity and a low limit of detection. This study aimed to develop and evaluate, both analytically and clinically, an antigen rapid diagnostic test (the Kestrel COVID-19 Ag Rapid Test) for professional use. A lateral flow immunoassay-based diagnostic test kit was developed, and various aspects of its analytical performance were evaluated. This test kit was clinically evaluated by two independent laboratories and showed closely related results of 96.49% and 98.33% of sensitivity, 100% and 100% of specificity, and 99.01% and 99.44% of accuracy, respectively. A limit of detection was observed at values as low as 0.156 ng/mL for recombinant SARS-CoV-2 nucleocapsid protein. Moreover, the test kit successfully detected the recombinant SARS-CoV-2 nucleocapsid protein (NP) of wild-type, Alpha-, Beta-, Gamma-, Delta-, Epsilon-, Kappa-, and Omicron-variants as positive results. Therefore, the Kestrel COVID-19 Ag Rapid Test may have potential use for effective COVID-19 screening, surveillance, and infection control in a variety of global SARS-CoV-2 variant outbreaks.
抗原快速诊断测试（Ag-RDT）是一种用于检测和管理新冠病毒传播的有用诊断工具。全球严重急性呼吸综合征冠状病毒2（SARS-CoV-2）变异株的爆发凸显了需要一种能够高灵敏度检测SARS-CoV-2变异株且检测限低的测试。本研究旨在开发并在分析和临床方面评估一种供专业使用的抗原快速诊断测试（Kestrel新冠病毒抗原快速检测）。开发了一种基于侧向流动免疫分析的诊断测试试剂盒，并评估了其分析性能的各个方面。该测试试剂盒由两个独立实验室进行临床评估，结果显示灵敏度分别为96.49%和98.33%、特异性均为100%、准确度分别为99.01%和99.44%，结果密切相关。对于重组SARS-CoV-2核衣壳蛋白，观察到检测限低至0.156 ng/mL。此外，该测试试剂盒成功检测到野生型、阿尔法、贝塔、伽马、德尔塔、伊普西龙、卡帕和奥密克戎变异株的重组SARS-CoV-2核衣壳蛋白（NP）呈阳性结果。因此，Kestrel新冠病毒抗原快速检测可能在各种全球SARS-CoV-2变异株爆发中用于有效的新冠病毒筛查、监测和感染控制。
