Evaluation of the rapid antigen detection test STANDARD F COVID-19 Ag FIA for diagnosing SARS-CoV-2: experience from an Emergency Department.
Diagn Microbiol Infect Dis
; 103(2): 115683, 2022 Jun.
Article
en En
| MEDLINE
| ID: mdl-35421760
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.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
SARS-CoV-2
/
COVID-19
Tipo de estudio:
Diagnostic_studies
/
Prognostic_studies
Límite:
Humans
Idioma:
En
Revista:
Diagn Microbiol Infect Dis
Año:
2022
Tipo del documento:
Article
Pais de publicación:
Estados Unidos