Comparison between the Sofia SARS antigen FIA test and the PCR test in detection of SARS-CoV-2 infection

Černila, Manca (author), Logar, Mateja (author), Možina, Hugon (author), Osredkar, Joško (author)

Objective: The purpose of this study was to compare Quidel’s rapid antigen test Sofia SARS antigen Fluorescent Immunoassay (FIA) (Sofia) with the real-time reverse transcription–polymerase chain reaction (rRT-PCR) test. Methods: Two samples were taken from each test subject—1 for testing with the Sofia test and 1 for testing with the rRT-PCR test. In total, swabs were taken from 146 subjects who presented symptoms of infection (group 1) and 672 subjects who were tested regardless of symptoms (group 2). Results: In group 1, the sensitivity of the antigen test was 90.0% and its specificity 97.5%. In group 2, however, the sensitivity of the antigen test was 81.4% and the specificity 98.9%. In addition to asymptomatic patients, false-negative results of rapid antigen tests also occurred in subjects with high threshold values (cycle threshold > 30). Conclusion: Our results show that the Sofia test meets the standards for diagnostic tests according to the criteria of the World Health Organization, as they show high sensitivity and specificity, and perhaps most importantly, a high negative predictive value (> 95%).

• Language: English
• Keywords: COVID-19, SARS-CoV-2, Sofia SARS antigen FIA, clinical validity, analytical validity, rapid antigen testing
• Work type: Article
• Typology: 1.01 - Original Scientific Article
• Organization: FFA - Faculty of Pharmacy
• Publication status: Published
• Publication version: Version of Record
• Year: 2023
• Number of pages: Str. e44–e48
• Numbering: Vol. 54, iss. 2
• PID: 20.500.12556/RUL-144980
• UDC: 616-07:616.98-036.21:578.834
• ISSN on article: 1943-7730
• DOI: 10.1093/labmed/lmac079
• COBISS.SI-ID: 118589187
• Publication date in RUL: 28.03.2023

Record is a part of a journal

• Title: Laboratory medicine
• Shortened title: Lab. med.
• Publisher: Oxford University Press, American Society for Clinical Pathology
• ISSN: 1943-7730
• COBISS.SI-ID: 525526553

Licences

• License: CC BY 4.0, Creative Commons Attribution 4.0 International
• Link: http://creativecommons.org/licenses/by/4.0/
• Description: This is the standard Creative Commons license that gives others maximum freedom to do what they want with the work as long as they credit the author.

Secondary language

• Language: Slovenian
• Keywords: Sofia SARS antigen FIA, klinična veljavnost, analitična veljavnost, hitro testiranje na antigen, COVID-19, SARS-CoV-2, diagnostika