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. 2021 Oct 31;62(5):513-517.
doi: 10.3325/cmj.2021.62.513.

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

Martina Ifko  1 , Željka Tkalčić Švabek, Iva Friščić, Mirjana Mariana Kardum Paro, Ingrid Prkačin, Lovorka Đerek, Ana Livun, Miha Skvarč
Affiliations

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

Martina Ifko et al. Croat Med J. .

Abstract

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.

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