engleski

Diagnostic validation of a Point-of-Care severe acute respiratory syndrome Coronavirus 2 (SARS- CoV-2) antigen test

Background. The World Health Organization (WHO) set the standards how a point-ofcare (POCT) SARS- CoV-2 antigen test should be used according to their negative (NPV) and positive predictive value (PPV) with minimum requirements for their sensitivity (80%) and specificity (97%). In this abstract we present diagnostic validation data of a POCT SARS-CoV-2 antigen test validated in Department of Medical Biochemistry and Laboratory Medicine Merkur University Hospital. Method. Two respiratory samples from one patient with at least one clinical sign of COVID-19 infection were collected at the same time, whereby the first was used for the reference method RT-PCR and the second for POCT SARS-CoV-2 antigen testing. 21 negative and 18 positive RT-PCR samples (Ct values 15 – 32) were used for diagnostic validation of a POCT SARS-CoV-2 antigen test (Roche, Mannheim, Germany) according to the SARS-CoV-2 Rapid Antigen test protocol (Guidance for local evaluations, October 9, 2020, Roche). Results. The concordance of the reference method (RT-PCR) and immunochromatografic assay (POCT SARSCoV-2 antigen testing) was determined by concordance analysis (inter-rater agreement kappa). The strength of coincidence described as the Kappa value (K) or the estimated Kappa value (Kw) was 0.85 and interpreted as very good. Conclusion. Our results show that the diagnostically validated POCT SARS- CoV-2 antigen test (Roche, Mannheim, Germany) exceeded the criteria defined by WHO for minimum sensitivity and specificity and demonstrated a high correlation with RT-PCR as reference method. Its high PPV value supports reliable and rapid detection of acute SARS-CoV-2 infection, while negative findings should always be confirmed by the reference method RT-PCR. Due to an extensive diagnostic validation POCT SARS-CoV-2 antigen test could be helpful in Emergency Units as a screening method for suspected SARS-CoV-2 infection.

diagnostic validation ; antigen test ; SARS-CoV-2

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