Intended Use: The Chlamydia Trachomatis Ag Test is a rapid chromatographicimmunoassay for the qualitative detection of Chlamydia trachomatisin male urethral swab and female cervical swab to aid in thediagnosis of Chlamydia infection.
 
Summary: Chlamydia trachomatis is the most common cause of sexuallytransmitted venereal infection in the world. It is composed ofelementary bodies (the infectious form) and reticulate or inclusionsbodies (the replicating form). Chlamydia trachomatis has both a highprevalence and asymptomatic carriage rate, with frequent seriouscomplications in both women and neonates. Complications ofChlamydia infection in women include cervicitis, urethritis, endometritis, pelvic inflammatory disease (PID) and increasedincidence of ectopic pregnancy and infertility.1 Vertical transmissionof the disease during parturition from mother to neonate can resultin 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 Trachomatis Ag Test is a rapid test to qualitatively detect the Chlamydia antigen from clinical specimens, providingresults in 10 minutes. The test utilizes antibody specific for Chlamydia to selectively detect Chlamydia antigen from clinical specimens.