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. 2019 Jan;39(1):31-35.
doi: 10.3343/alm.2019.39.1.31.

Evaluation of the SD Bioline Strep A Ultra Test in Relation With Number of Colony Forming Units and Color Intensity

Sang Hyuk Ma  1 , Won Hee Choi  2 , Hyunwoong Park  3 , Sunjoo Kim  4   5
Affiliations

Evaluation of the SD Bioline Strep A Ultra Test in Relation With Number of Colony Forming Units and Color Intensity

Sang Hyuk Ma et al. Ann Lab Med. 2019 Jan.

Abstract

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.

Keywords: Evaluation; Group A Streptococcus; Pharyngitis; Rapid antigen detection test.

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Conflict of interest statement

No potential conflicts of interest relevant to this article were reported.

Figures

Fig. 1
Fig. 1. ROC plot for color intensity of SD Bioline Ultra test.
Abbreviation: CI, confidence interval.
See this image and copyright information in PMC

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