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Ann Lab Med. 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.

Author information

1
Department of Pediatrics, Changwon Fatima Hospital, Changwon, Korea.
2
Department of Nursing Science, Kyungsung University, Busan, Korea.
3
Department of Laboratory Medicine, Seoul National University Boramae Medical Center, Seoul, Korea.
4
Department of Laboratory Medicine, Gyeongsang National University College of Medicine, Jinju, Korea.
5
Gyeongsang Institute of Health Sciences, Jinju, Korea. sjkim8239@hanmail.net.

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

PMID:
30215227
PMCID:
PMC6143457
DOI:
10.3343/alm.2019.39.1.31
[Indexed for MEDLINE]
Free PMC Article

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