Expected use
The Chlamydia One-Step Test is designed for in vitro diagnostic use in the rapid and qualitative detection of Chlamydia trachomatis IgM antibody directly from human serum. The test is designed to be used to help diagnose chlamydia infections.
Summary and explanation
Chlamydia includes three species: Chlamydia trachomatis, Chlamydia pneumonia, and Chlamydia psittasi. Chlamydia trachomatis, a human pathogen, is subdivided into 15 known serovars; 3 are associated with Lymphogranuloma Venereum and the remaining 12 with trachomatis and genitourinary infection. Common complications in chlamydia-infected women include cerciitis, urethritis, endometritis, pelvic inflammatory disease, and an increased incidence of ectopic pregnancies and infertility, and in men they include urethritis and epididymitis. Chlamydia trachomatis infection has a high prevalence and an asymptomatic carrier rate. Approximately 70% of women with endocervical infections and up to 50% of men with urethral infections are asymptomatic.
Chlamydia psittasi, primarily an animal pathogen, is associated with a respiratory disease caused by exposure to infected birds and is not transmitted through human interaction. Chlamydial pneumonia, first isolated in 1983, is a human pathogen and is associated with respiratory infections and pneumonia. Traditionally, chlamydial infection is diagnosed by detecting chlamydial inclusions in tissue culture cells. Although this method is the most sensitive and specific laboratory method, it is expensive, labor-intensive, time-consuming (48 to 72 hours), and not routinely available in most institutions. The direct immunofluorescence assay requires specialized equipment and a trained operator to interpret the results. The one-step Chlamydia test, using the gold particle-based immunoassay, provides a simple, rapid, specific, but highly sensitive method of detection of Chlamydia antigen.
