Ann Lab Med 2019; 39(1): 31-35  https://doi.org/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, M.D.1, Won-Hee Choi, Ph.D.2, Hyunwoong Park, M.D.3, and Sunjoo Kim, M.D.4,5
1Department of Pediatrics, Changwon Fatima Hospital, Changwon, Korea; 2Department of Nursing Science, Kyungsung University, Busan, Korea; 3Department of Laboratory Medicine, Seoul National University Boramae Medical Center, Seoul, Korea; 4Department of Laboratory Medicine, Gyeongsang National University College of Medicine, and 5Gyeongsang Institute of Health Sciences, Jinju, Korea
Corresponding author: Sunjoo Kim, M.D.
https://orcid.org/0000-0001-8099-8891
Department of Laboratory Medicine, Gyeongsang National University College of Medicine, 79 Gangnam-ro, Jinju 52727, Korea
Tel: +82-55-214-3072
Fax: +82-55-214-3087
E-mail: sjkim8239@hanmail.net
Received: December 27, 2017; Revised: June 14, 2018; Accepted: August 27, 2018; Published online: January 1, 2019.
© Korean Society for Laboratory Medicine. All rights reserved.

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
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: Group A Streptococcus, Pharyngitis, Rapid antigen detection test, Evaluation



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