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Diagnostic validation of two SARS-CoV-2 immunochromatographic tests in Slovenian and Croatian hospitals

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). 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 Slowenian hospitals, while only ALLTEST COVID-19 Antigen test was validated in two Croatia hospitals. The antigen test results were in very good agreement with the RT-PCR results (Cohens 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%. 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.

point-of-care (POC) rapid antigen tests, SARS-CoV-2

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