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A군 사슬알균 인두염 진단을 위한 STANDARD F Strep A Ag FIA의 성능 평가

Performance Evaluation of STANDARD F Strep A Ag FIA for Diagnosis of Group A Streptococcal Pharyngitis

Annals of Clinical Microbiology 2020년 23권 3호 p.177 ~ 184
조선아, 마상혁, 이승준, 김선주,
소속 상세정보
조선아 ( Jo Seon-A ) - Daewoo General Hospital Department of Laboratory Medicine
마상혁 ( Ma Sang-Hyuk ) - Changwon Fatima Hospital Department of Pediatrics
이승준 ( Lee Seung-Jun ) - Gyeongsang National University Changwon Hospital Department of Laboratory Medicine
김선주 ( Kim Sun-Joo ) - Gyeongsang National University Changwon Hospital Department of Laboratory Medicine

Abstract


Background: Pharyngitis is one of the most common conditions encountered in primary health care facilities. Accurate differentiation of group A streptococcus (GAS) infection from viral infection is difficult. The STANDARD F Strep A Ag FIA (SD BIOSENSOR, Korea) is a rapid antigen detection test (RADT) that has been recently developed for diagnosing GAS pharyngitis. In this study, we evaluated the diagnostic performance of the STANDARD F Strep A Ag FIA and compared the results between the RADT and conventional throat culture.

Methods:Throat swab samples were obtained from a total of 372 children presenting pharyngitis symptoms in five pediatric clinics in Changwon, Korea from July 2018 to October 2019. A comparative study between STANDARD F Strep A Ag FIA and Sofia Strep A FIA (Quidel, USA) was performed. Two throat swabs were taken simultaneously from each patient for RADT. The third throat swab was stored in a transport tube containing Stuart's transport medium for culture. Performance and kappa index of STANDARD F Strep A Ag FIA were evaluated.

Results: GAS infection was detected in 29.3% (109/372) patients, using the STANDARD F Strep A Ag FIA. The sensitivity, specificity, positive predictive value, and negative predictive value were 95.0%, 95.2%, 88.1%, and 98.1%, respectively. The STANDARD F Strep A Ag FIA showed an excellent concordance rate of 96.5% and a kappa value of 0.89 compared to Sofia Strep A FIA.

Conclusion: The STANDARD F Strep A Ag FIA demonstrated an excellent performance along with Sofia Strep A FIA for the diagnosis of GAS pharyngitis.

키워드

Group A streptococcus; Pharyngitis; Rapid antigen test; Streptococcus pyogenes; Tonsillitis

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