Author(s)

Zhang Lei ¹, Yang Feng ², Zhu Junzhe ³

Affiliation(s)

¹ Zhejiang Gongshang University, Hangzhou, Zhejiang, 310018, China
² Community Health Service Center, Hangzhou, Zhejiang, 310000, China
³ Wenzhou Medical University, Wenzhou, Zhejiang, 310000, China

Corresponding Author

Zhang Lei

ABSTRACT

The Strep A Rapid Test Cassette (Throat Swab) is a chromatographic immunoassay designed for the qualitative detection of Group A Streptococcus (GAS) antigens from human throat swab specimens, aiding in the diagnosis of streptococcal pharyngitis. This study aimed to evaluate the clinical performance of the CITEST DIAGNOSTICS INC. Strep A Rapid Test by comparing its results with the reference method of bacterial culture. A total of 526 throat swab specimens collected from individuals with suspected strep A infection were tested concurrently with the rapid test and culture. The results demonstrated that the rapid test had a relative sensitivity of 95.1% (95% CI: 89.6%–98.2%), a relative specificity of 97.8% (95% CI: 95.8%–99.0%), and an overall accuracy of 97.1% (95% CI: 95.3%–98.4%) compared to culture. The test exhibited no cross-reactivity with a panel of common oropharyngeal flora and potential interfering organisms. The device remained stable under recommended storage conditions (2–30°C). These findings confirm that the Strep A Rapid Test Cassette is a reliable, rapid and practical tool for the detection of GAS antigens in throat swabs, facilitating timely diagnosis and management of streptococcal pharyngitis in point-of-care settings.

KEYWORDS

Streptococcus pyogenes; Group A Streptococcus; Rapid Diagnostic Test; Throat Swab; Immunochromatography; Pharyngitis; Point-of-Care Testing

CITE THIS PAPER

Zhang Lei, Yang Feng, Zhu Junzhe, Performance Evaluation of the Strep A Rapid Test Cassette (Throat Swab) for Point-of-Care Testing via Clinical Validation. MEDS Clinical Medicine (2025) Vol. 6: 71-75. DOI: http://dx.doi.org/10.23977/medsc.2025.060510.

REFERENCES

[1] Bisno AL, Gerber MA, Gwaltney JM Jr, Kaplan EL, Schwartz RH. Diagnosis and management of Group A streptococcal pharyngitis: a practice guideline. Clin Infect Dis. 1997;25(3):574-583.
[2] Carapetis JR, McDonald M, Wilson NJ. Acute rheumatic fever. Lancet. 2005;366(9480):155-168.
[3] Cunningham MW. Pathogenesis of group A streptococcal infections. Clin Microbiol Rev. 2000;13(3):470-511.
[4] Shulman ST, Bisno AL, Clegg HW, et al. Clinical practice guideline for the diagnosis and management of group A streptococcal pharyngitis: 2012 update by the Infectious Diseases Society of America. Clin Infect Dis. 2012; 55(10): e86-e102.
[5] Murray PR, Baron EJ, Pfaller MA, Tenover FC, Yolken RH, eds. Manual of Clinical Microbiology. 6th ed. Washington, DC: ASM Press; 1995.
[6] Webb KH. Does culture confirmation of high-sensitivity rapid streptococcal tests make sense? A medical decision analysis. Pediatrics. 1998;101(2):E2.
[7] Gerber MA, Tanz RR, Kabat W, et al. Optical immunoassay test for group A beta-hemolytic streptococcal pharyngitis. An office-based, multicenter investigation. JAMA. 1997;277(11):899-903.
[8] Stewart EH, Davis B, Clemans-Taylor BL, Littenberg B, Estrada CA, Centor RM. Rapid antigen group A streptococcus test to diagnose pharyngitis: a systematic review and meta-analysis. PLoS One. 2014;9(11):e111727.
[9] Cohen JF, Bertille N, Cohen R, Chalumeau M. Rapid antigen detection test for group A streptococcus in children with pharyngitis. Cochrane Database Syst Rev. 2016;7(7):CD010502.
[10] Lean WL, Arnup S, Danchin M, Steer AC. Rapid diagnostic tests for group A streptococcal pharyngitis: a meta-analysis. Pediatrics. 2014;134(4):771-781.
[11] Lancefield RC. A serological differentiation of human and other groups of hemolytic streptococci. J Exp Med. 1933; 57(4): 571-595.

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