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, Yipeng Street, Qiantang District, Hangzhou, Zhejiang, 310000, China
³ Wenzhou Medical University, Wenzhou, Zhejiang, 310000, China

Corresponding Author

Zhang Lei

ABSTRACT

Group A Streptococcus (GAS) is a bacterium that is commonly present in the throat and on the skin surfaces of humans, typically as a gram-positive organism. It is a commonly found pathogen that can cause a variety of infections and diseases. Timely diagnosis and appropriate treatment with antibiotics are crucial to prevent complications and further transmission of the bacteria. The study aimed to evaluate the diagnostic capacity of the Strep A Rapid Test in qualitatively identifying Strep A antigens through specific antibodies that target whole-cell Lancefield Group A Streptococcus. The test detects the existence of Strep A antigens in specimens obtained from throat swabs to aid in the diagnosis of Group A Streptococcal infection. 526 throat swabs from pharyngitis patients across three medical centers were gathered to gauge the sensitivity, specificity, and accuracy of the Strep A rapid test. The study findings revealed that the Strep A rapid test accurately identified 95.1% of the true positive cases and correctly detected 97.8% of the negative cases, yielding an overall accuracy of 97.1%. Among the 526 specimens examined, 404 tested negative, whereas 122 tested positive through culture-based testing, with one instance of a false positive result. Furthermore, cross-reactivity testing involving three distinct Strep F strains produced negative results, further confirming the specificity of the Strep A rapid test. This test developed by Hangzhou AllTest Biotech Co., Ltd has demonstrated excellent performance in detecting Strep A antigens in specimens collected from throat swabs, rendering it suitable for clinical application as an auxiliary diagnostic tool, particularly beneficial in resource-limited environments due to its high accuracy, reliability, and prompt results.

KEYWORDS

Group A streptococcus, Rapid test, Antigen detection, Diagnosis

CITE THIS PAPER

Zhang Lei, Yang Feng, Zhu Junzhe, Performance Evaluation of Strep A Rapid Test Cassette for Detecting Strep A Antigens in Throat Swab Specimens. MEDS Public Health and Preventive Medicine (2024) Vol. 4: 70-74. DOI: http://dx.doi.org/10.23977/phpm.2024.040111.

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