Evaluation of the rapid antigen detection test STANDARD F COVID-19 Ag FIA for diagnosing SARS-CoV-2: experience from an Emergency Department

• Published in: Diagnostic microbiology and infectious disease 2022-06, Vol.103 (2), p.115683-115683, Article 115683
• Main Authors: García-Fernández, Sergio, Pablo-Marcos, Daniel, de la Fuente, Silvia Velasco, Rodríguez, María José Reina, Gozalo, Mónica, Rodríguez-Lozano, Jesús, Méndez-Legaza, José Manuel, Calvo, Jorge
• Format: Article
• Language: English
• Subjects: Antigens, Viral - analysis; COVID-19; COVID-19 - diagnosis; COVID-19 Serological Testing; Emergency Department; Emergency Service, Hospital; Humans; Rapid antigen test; SARS-CoV-2; Sensitivity and Specificity
• ISSN: 0732-8893; 1879-0070
• DOI: 10.1016/j.diagmicrobio.2022.115683

The purpose of this study was to assess the clinical performance of STANDARD F COVID-19 Ag FIA (SD Biosensor Inc., Gyeonggi-do, Republic of Korea), a rapid antigen detection test (RADT) for diagnosing SARS-CoV-2, in patients attended at the Emergency Department with signs or symptoms compatible with COVID-19 that had started in the last 5 days. The clinical performance of the antigen test was compared with RT-PCR, the reference standard. We included 663 specimens from non-repetitive patients. Clinical sensitivity and specificity were 84.0% (95% CI 76.1−89.7) and 99.6% (95% CI 98.5−99.9), respectively. The positive and negative predictive values were 98.1% (95% CI 92.7−99.7) and 96.4% (95% CI 94.4−97.7), respectively. The kappa index agreement between RT-PCR and the RADT was 0.89 (95% CI 0.84−0.93). We concluded that STANDARD F COVID-19 Ag FIA is an excellent first-line RADT method to diagnose symptomatic patients in the emergency department.