Izvorni znanstveni članak
https://doi.org/10.3325/cmj.2021.62.513
Diagnostic validation of two SARS-CoV-2 immunochromatographic tests in Slovenian and Croatian hospitals
Martina Ifko
; Doba Faculty, Maribor, Slovenia
Željka Tkalčić Švabek
; Clinical Department of Laboratory Diagnostics, University Hospital Center Zagreb, Zagreb, Croatia
Iva Friščić
; Department of Medical Biochemistry and Laboratory Medicine, Merkur University Hospital, Zagreb, Croatia
Mirjana Mariana Kardum Paro
; Department of Medical Biochemistry and Laboratory Medicine, Merkur University Hospital, Zagreb, Croatia
Ingrid Prkačin
; Department of Internal Medicine, Merkur University Hospital, Zagreb, Croatia
Lovorka Đerek
; Clinical Department for Laboratory Diagnostics, Dubrava University Hospital, Zagreb, Croatia
Ana Livun
; Clinical Department for Laboratory Diagnostics, Dubrava University Hospital, Zagreb, Croatia
Miha Skvarč
; Microbiological Department, General Hospital Jesenice, Jesenice, Slovenia
Sažetak
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
Ključne riječi
Hrčak ID:
278798
URI
Datum izdavanja:
21.10.2021.
Posjeta: 319 *