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.
The clinical validation of the NADAL COVID-19 antigen test (Nal von Minden, Moers, Germany) started in eight Slovenian long-term health care facilities in October 2020. The purpose of clinical validation is to implement the test into the everyday working process in long-term care (LTC) facilities and demonstrate how it can be used to mitigate the spread of the virus in these environments. The facilities compared the results of antigen tests to the results obtained using Cobas 6800 SARS-CoV-2 real-time reverse transcription polymerase chain reaction (RT-PCR) (Roche, USA).
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