eISSN: 2299-0046
ISSN: 1642-395X
Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii
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vol. 39
Letter to the Editor

The utility of rapid FIA antigen test to detect SARS-CoV-2 infection – preliminary experiences of the Hospital for Infectious Diseases in Warsaw

Andrzej Horban
Justyna D. Kowalska
Tomasz Dyda
Piotr Ząbek
Hanna Czeszko-Paprocka

Department of Adults’ Infectious Diseases, Medical University of Warsaw, Warsaw, Poland
Molecular Diagnostics Laboratory, Hospital for Infectious Diseases, Warsaw, Poland
Central Analytical Laboratory, Hospital for Infectious Diseases, Warsaw, Poland
Adv Dermatol Allergol 2022; XXXIX (3): 613-614
Online publish date: 2020/11/04
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Since the beginning of the SARS-CoV-2 epidemic, several diagnostic techniques have been developed to detect the infection. Real-time reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay is considered the gold standard in confirming the diagnosis of COVID-19 in clinical settings [1]. However RT-PCR technology is considered time consuming, costly and requires significant resources, both in terms of available laboratory equipment and experienced staff. Therefore, using RT-PCR in epidemiological surveillance or in mass testing is difficult and meeting the necessary number of tests to be performed has been shown to be impossible in practical terms. On the contrary, antigen tests can be used as point-of-care diagnostics with a rapid turnaround time and could play a critical role in implementation of infection prevention and control strategies. The Centres of Disease Control and Prevention (CDC) provides interim guidance to support effective use of antigen tests for different testing situations as they become available on the market and are therefore bought by physicians [2]. The World Health Organisation (WHO) does not provide a specific recommendation on the basis of which, before these tests can be recommended, they must be further validated in given populations and settings [3–5]. In fact there is a lack of reliable research regarding the usefulness of these tests in the laboratory diagnosis of infections caused by SARS-CoV-2 [6]. Therefore, we performed comparative testing for the antigen test available from the Ministry of Health resources to all public health services using RT-PCR test as the gold standard.
PCL COVID-19 Ag Rapid FIA (Ag Rapid FIA) is an in vitro diagnostic medical device using sandwich fluorescent immunoassay to qualitatively detect SARS-CoV-2 antigen in human nasopharyngeal and sputum specimens [7]. We have performed analyses of 266 nasopharyngeal samples collected from patients hospitalized in the Hospital for Infectious Diseases in Warsaw. SARS-Cov-2 infection was confirmed in 40 samples by real time RT-PCR (SARS-CoV-2 Genesig Real-Time PCR Assay, Vitassay). Sixteen of these samples were positive in PCL COVID-19 (Ag Rapid FIA) test (Serial no. COV05-2003N405 and COV05-2003N401) and five of 226 SARS-CoV-2 negative samples were positive in Ag Rapid FIA. Basing on these results, sensitivity was calculated as 40% (16 of 40) and specificity as 98% (221 of 226).
In addition, we recalculated sensitivity of Ag Rapid...

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