Accurate diagnosis at the right moment is the prerequisite for treatment of any disease. Failure to correctly diagnose a disease can result in highly detrimental effects, unmistakably a crucial factor during the COVID-19 pandemic. RT-PCR is the gold standard for COVID-19 detection while there are other test procedures available, such as LAMP, X-Ray, and ELISA. However, these tests are expensive, require sophisticated equipment and a highly trained workforce, and multiple hours or even days are often required to obtain the test results. A rapid and cheap detection system can thus render a solution to the screening system on a larger scale and be added as an aid to the current detection processes. Recently, some rapid antigen-based COVID-19 tests devices have been developed and commercialized. In this study, we evaluated the clinical performance of a new rapid detection device ( OnSite ® COVID-19 Ag Rapid Test by CTK Biotech Inc., Poway, CA, USA) on COVID-19 symptomatic patients ( n = 380). The overall sensitivity and specificity were 91.0% (95% CI: 84.8–95.3%) and 99.2% (95% CI: 97.1–99.9), against gold standard RT-PCR. The kit was capable of detecting patients even after 06 days of onset of symptoms and the sensitivity can be maximized to 98% in samples with an average RT-PCR Ct ≤ 26.48, demonstrating a high potential of the kit for clinical diagnosis of symptomatic patients in healthcare facilities.
【저자키워드】 COVID-19, SARS-CoV-2, pandemic, diagnostics, 2019 novel coronavirus, PCR, Rapid antigen detection, Rapid test, Surveillance, 【초록키워드】 Treatment, equipment, COVID-19 pandemic, Test, Diagnosis, RT-PCR, ELISA, sensitivity, Sensitivity and specificity, healthcare, Patient, Rapid, USA, disease, Clinical diagnosis, diagnose, COVID-19 test, failure, gold standard, average, detrimental effects, RT-PCR Ct, detection system, evaluated, required, onset of symptom, added, COVID-19 symptomatic patient, Inc., symptomatic patient, 【제목키워드】 Test, clinical, Rapid, New,