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  • Chlamydia Antigen Rapid Test
  • Chlamydia Antigen Rapid Test

Chlamydia Antigen Rapid Test

Usage
The Chlamydia Antigen Rapid Test is a rapid, lateral flow chromatographic immunoassay for the qualitative detection of Chlamydia antigen in female cervical swab and male urethral swab specimens. It is intended to be used by healthcare professionals as a test to aid diagnosis of infection with Chlamydia trachomatis. The test only provides preliminary analysis results but not critical criteria. Any use or interpretation of the test must be analyzed and confirmed with alternative testing method(s) and clinical findings based on professional judgment of healthcare providers.

 

Background of Clinical Indications

Chlamydia trachomatis is the most common cause of sexually transmitted venereal infection in the world. It is composed of elementary bodies (the infectious form) and reticulate or inclusion bodies (the replicating form). Chlamydia trachomatis has both a high prevalence and asymptomatic carriage rate, with frequent serious complications in both women and neonates. Complications of Chlamydia infection in women include cervicitis, urethritis, endometritis, pelvic inflammatory disease (PID) and increased incidence of ectopic pregnancy and infertility. Vertical transmission of the disease during parturition from to neonate can result in inclusion conjunctivitis or pneumonia. In men, complication of Chlamydia includes urethritis and epididymitis. At least 40% of the nongonococcal urethritis cases are associated with Chlamydia infection. Approximately 70% of women with endocervical infections and up to 50% of men with urethral infections are asymptomatic. Traditionally, Chlamydia infection has been diagnosed by detection of Chlamydia inclusions in tissue culture cells. Culture method is the most sensitive and specific laboratory method,but it is labor intensive, expensive, long (18-72 hours) and not routinely available in most situations. The Chlamydia Antigen Rapid Test utilizes of specific monoclonal antibodies to qualitatively detect Chlamydia antigen in female cervical swab and male urethral swab specimens. The test can be performed without cumbersome laboratory equipment, and the results are available within 20 minutes.

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Packing specification

Principle of Inspection

The Chlamydia Antigen Rapid Test is a qualitative membrane-based immunoassay for the detection of Chlamydia antigen in female cervical swab and male urethral swab specimens. The membrane is pre-coated with specific monoclonal antibodies in the test line region. During testing, the extracted specimen reacts with the particle coated with anti-Chlamydia antibodies to form an antigen-antibody-gold complex. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-Chlamydia antibodies immobilized in the membrane and produce a colored line. The presence of this colored line in the test line region (T), indicates a positive result, while its absence indicates a negative result. An internal quality control is included in the test, in the form of a colored line appearing in the control line region (C), indicating that the test is functional, and proper and sufficient volume of specimen has been applied to enable migration through the test and control line, regardless of whether there is a test line or not. If the control line (C) does not appear within the testing time, test result is invalid and the test should be repeated with a new test device.

Specification packaging

1 Test/Kit, 2 Tests/Kit, 5 Tests/Kit, 7 Tests/Kit, 10 Tests/Kit, 20 Tests/Kit, 25 Tests/Kit, 40 Tests/Kit.

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About Kangte

Zhejiang Kangte Biotechnology Co., Ltd

Zhejiang Kangte Biotechnology Co., Ltd. was established in 2001 and is located in Zhejiang Xinchang Provincial High-tech Industrial Park. It is a national high-tech enterprise integrating R&D, production and sales of in vitro diagnostic reagents. Relying on the pioneering team spirit and scientific management, the company has repeatedly won the national advanced production unit in the in vitro diagnostic industry. 

The company has GMP standard workshops, clean workshops, R&D laboratories, equipped with high-precision testing equipment and fully automatic production equipment. In order to enhance the company's overall R&D strength, it has established a good "production-study-research" cooperative relationship with many colleges and universities. The company has obtained a number of invention patents and utility model patents and has passed ISO9001, ISO14001, ISO13485, and other system certifications. The company currently has more than 100 registered products, covering biochemical, immunological, and other fields, and many of the products have reached the leading domestic level in technology. 

The company adheres to the concept of "integrity, professionalism, efficiency and innovation" to serve customers, and constantly introduces products with higher technological content to provide customers. The company will, as always, position itself in "service technology, professionalism and efficiency, and achieve customers", and work hard to jointly shape the IVD industry and continuously improve the level of human health.

 

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