Evaluation of the SD Bioline Strep A Ultra Test in Relation With Number of Colony Forming Units and Color Intensityopen access
- Ma, Sang Hyuk; Choi, Won-Hee; Park, Hyunwoong; Kim, Sunjoo
- Issue Date
- KOREAN SOC LABORATORY MEDICINE
- Group A Streptococcus; Pharyngitis; Rapid antigen detection test; Evaluation
- ANNALS OF LABORATORY MEDICINE, v.39, no.1, pp.31 - 35
- Journal Title
- ANNALS OF LABORATORY MEDICINE
- Start Page
- End Page
- Background: The SD Bioline Strep A Ultra (SD, Yongin, Korea) is a recently developed rapid antigen detection test (RADT) for diagnosing bacterial pharyngitis caused by Group A Streptococcus, We evaluated the performance of SD Bioline Strep A Ultra, using the number of colony forming units and color intensity. Methods: Three throat swabs each were taken from 343 children with pharyngitis who visited pediatric clinics. We evaluated the performance of SD Bioline Strep A Ultra and compared its positive rate with the number of colony forming units, using the Fisher exact test. Results: The sensitivity, specificity, positive predictive value, and negative predictive value (95% confidence interval) were 97.4% (94.0-99.1%), 90.8% (85.0-94.9%), 93.0% (88.5-96.1%), and 96.5% (92.0-98.9%), respectively. Positive rate significantly differed by number of colony forming units (P = 0.021). ROC plot for color intensity showed 0.938 of AUC (area under curve). Conclusions: SD Bioline Strep A Ultra showed excellent performance, and its positive rate differed by the number of colony counts. This RADT could be used as a sensitive and semi-quantitative method detecting bacterial pharyngitis.
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- College of Medicine > Department of Medicine > Journal Articles
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