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  4. Vol 5, Issue 1, 2024

Performance Evaluation of the Chlamydia Rapid Test for Qualitative Detection of Chlamydial Antigens in Clinical Diagnosis

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DOI: 10.23977/medsc.2024.050124 | Downloads: 7 | Views: 94

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

In this study, the objective was to evaluate the diagnostic performance of the Chlamydia Rapid Test, a rapid chromatographic immunoassay specifically designed for the qualitative detection of Chlamydia trachomatis in various specimen types. The aim was to improve the diagnosis of Chlamydia infection, considering its global prevalence as the leading cause of sexually transmitted venereal infection. The material and methods involved evaluating the sensitivity, specificity, and accuracy of the Chlamydia rapid test using specimens obtained from patients at STD clinics. The Chlamydia Rapid Test Cassette (Swab/Urine) was compared to PCR, which served as the reference method for the evaluation. The research findings demonstrated the high accuracy of the Chlamydia Rapid Test in detecting the microorganism across different specimen types. For female cervical swab specimens, the test exhibited a relative sensitivity of 93.3% and a relative specificity of 97.5%, resulting in an overall accuracy of 96.6%. In the case of male urethral swab specimens, the relative sensitivity was 86.2% and the relative specificity was 95.8%, with an overall accuracy of 92.7%. Additionally, for male urine specimens, the test displayed a relative sensitivity of 94.6% and a relative specificity of >99.9%, leading to an overall accuracy of 97.9%. These results highlight the effectiveness of the test in precisely identifying the presence or absence of the microorganism in diverse specimen types. In conclusion, the Chlamydia Rapid Test developed by Hangzhou AllTest Biotech Co., Ltd has demonstrated excellent performance in detecting Chlamydia antigen in various specimen types, including female cervical swabs, male urethral swabs, and male urine samples. Due to its high accuracy and reliability, this test is suitable for clinical application as an auxiliary diagnostic tool. Furthermore, its quick and accurate results make it particularly valuable in facilitating timely diagnosis and treatment, especially in resource-limited areas.

KEYWORDS

Chlamydia trachomatis, Diagnostics, Point-of-care, Immunoassay test

CITE THIS PAPER

Zhang Lei, Yang Feng, Zhu Junzhe, Performance Evaluation of the Chlamydia Rapid Test for Qualitative Detection of Chlamydial Antigens in Clinical Diagnosis. MEDS Clinical Medicine (2024) Vol. 5: 158-163. DOI: http://dx.doi.org/10.23977/medsc.2024.050124.

REFERENCES

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