Aim To diagnostically validate two point-of-care (POC) rapid antigen tests for SARS-CoV-2 by comparing their results with those of laboratory-based real-time polymerase chain reaction tests (RT-PCR). Methods The study enrolled 455 patients from two Slovenian and two Croatian hospitals. The NADAL COVID-19 Ag Test (Nal von Minden, Moers, Germany) and ALLTEST COVID-19 Antigen Test (Hangzhou ALLTEST Biotech Co., Ltd, Hangzhou, China) were diagnostically validated in emergency care departments of two Slovenian hospitals, while only ALLTEST COVID-19 Antigen Test was validated in two Croatian hospitals. Results The antigen test results were in very good agreement with the RT-PCR results (Cohen’s Kappa between 0.747 and 0.891 for the NADAL COVID-19 and between 0.820 and 0.954 for the ALLTEST COVID-19). The NADAL COVID-19 Ag Test had the sensitivity between 66.67% and 92.31%, with a negative predictive value between 85.51% and 99.2%. The ALLTEST COVID-19 Antigen Test had the sensitivity between 81.39% and 91.11%, with a negative predictive value between 85.45% and 98.78%. Conclusion The antigen tests are practical and reliable screening assays for SARS CoV-2 in emergency care departments. Both antigen tests can be used as screening tests to reduce the number of patients waiting for RT-PCR results. Even more, they can be used to quickly isolate COVID-19 patients and reduce hospital transmissions.
【초록키워드】 COVID-19, SARS CoV-2, SARS-CoV-2, hospital, POC, Test, RT-PCR, hospitals, Antigen, China, point-of-care, sensitivity, rapid antigen test, Germany, Patient, Care, screening test, COVID-19 patient, Negative predictive value, transmissions, polymerase chain, Result, enrolled, can be used, reduce, Minden, Moers, 【제목키워드】 SARS-CoV-2, hospital, immunochromatographic test,