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KMID : 1100720190390010031
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Annals of Laboratory Medicine
2019 Volume.39 No. 1 p.31 ~ p.35
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Evaluation of the SD Bioline Strep A Ultra Test in Relation With Number of Colony Forming Units and Color Intensity
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Ma Sang-Hyuk
Choi Won-Hee
Park Hyun-Woong
Kim Sun-Joo
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Abstract
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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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KEYWORD
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Group A Streptococcus, Pharyngitis, Rapid antigen detection test, Evaluation
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