A rapid test for the qualitative detection of Chlamydia antigen in female cervical swab, male urethral swab and male urine specimens. For professional in vitro diagnostic use only. 

Chlamydia Antigen INTENDED USE 

The Chlamydia Rapid Test Device (Swab/Urine) is a rapid chromatographic immunoassay for the qualitative detection of Chlamydia trachomatis in female cervical swab, male urethral swab and male urine specimens to aid in the diagnosis of Chlamydia infection. 

Chlamydia Antigen SUMMARY 

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 inclusions 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.1 Vertical transmission ofthe disease during parturition from mother to neonatecan result in inclusion conjunctivitis pneumonia. In men, complications of Chlamydia infection include 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 (48-72 hours) and not routinely available in most institutions. The Chlamydia Rapid Test Device (Swab/Urine) is a rapid test to qualitatively detect the Chlamydia antigen from female cervical swab, male urethral swab and male urine specimens, providing results in 10 minutes. The test utilizes antibody specific for Chlamydia to selectively detect Chlamydia antigen from female cervical swab, male urethral swab and male urine specimens.