INTENDED USE

The Chlamydia Antigen Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of Chlamydia trachomatis in clinical specimens to aid in the diagnosis of Chlamydia infection.

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. Vertical transmission of the disease during parturition from mother to neonate can 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 Antigen Rapid Test Device is a rapid test to qualitatively detect the Chlamydia antigen from clinical specimens, providing results in 10 minutes. The test utilizes antibody specific for Chlamydia to selectively detect Chlamydia antigen from clinical specimens.

PRINCIPLE

The Chlamydia Antigen Rapid Test Device is a qualitative, lateral flow immunoassay for the detection of Chlamydia antigen from clinical specimens.
In this test, antibody specific to the Chlamydia antigen is coated on the test line region of the strip. During testing, the extracted antigen solution reacts with an antibody to Chlamydia that is coated onto particles. The mixture migrates up to react with the antibody to Chlamydia on the membrane and generate a red line in the test region. The presence of this red line in the test region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a red line will always appear in the control region indicating that proper volume of specimen has been added and membrane wicking has occurred.