Chlamydia Antigen

Chlamydia Antigen

Rapid test screening of vaginal specimen is a common and cost-efficient method for the diagnosis of Chlamydia infections. Chlamydia Antigen provides a ready-to-use kit including all necessary equipment with maximum user convenience.
Well proven, cost-efficient and user-friendly. That‘s Chlamydia Antigen.

 

INTENDED USE

The chlamydia antigen test is intended for in vitro diagnostic use in the rapid, qualitative detection of chlamydiae directly from female endocervical swabs and male urethral swabs and urine samples.

SUMMARY

The genus Chlamydia is made up of three species: Chlamydia trachomatis, Chlamydia pneumoniae (1), a primarily human pathogen, and Chlamydia psittaci, a primarily animal pathogen. Chlamydia trachomatis consists of 15 known serovars. These are associated with
urogenital infections and lymphogranuloma venereum (LGV). Chlamydia trachomatis infections are the most common bacterial sexually transmitted diseases. In the USA there are about 4 million new cases every year, mainly cervicitis and non-gonococcal urethritis (8). This organism also causes conjunctivitis and pneumonia in children (2, 4–7). Chlamydia trachomatis infections have both a high prevalence and asymptomatic carriage rate, with frequent serious complications in both women and neonates. Complications of chlamydia infections in women include cervicitis, urethritis, endometritis, pelvic inflammatory disease (PID) and increased incidence of ectopic pregnancy and infertility. Vertical transmission of the disease from the mother to the neonate during parturition can result in inclusion conjunctivitis and pneumonia (8). In men at least 40% of all cases of non-gonococcal urethritis are
associated with chlamydia infections and epididymitis (6). Approximately 70% of women with endocervical infections and up to 50% of men with urethral infections are symptomatic (8). Chlamydia psittaci infections are associated with respiratory diseases in individuals exposed to infected birds and are not transmitted from human to human. Chlamydia pneumoniae, which was first isolated in 1983, is associated with respiratory infections and pneumonia (2). Traditionally chlamydia infections have been diagnosed by the detection of chlamydiae in tissue culture cells or polymerase chain reaction (PCR). Together with PCR, the culture method is the most sensitive and specific laboratory method, but it is labour-intensive and expensive, it takes a long time (2–3 days) and is not routinely available in most institutions (2, 3, 7). Direct tests such as immunofluorescence assay (IFA) require special equipment and a skilled operator to read the results.

PRINCIPLE

The chlamydia antigen test is a rapid immunochromatographic test. In the test procedure a clinical specimen is obtained and placed in an extraction tube with extraction solution A. After 2 minutes extraction solution B is added to the tube. After extraction 3 drops (approximately 120 µl) of the extracted sample are added to the test cassette sample well. In the test the membrane was coated with antigen-specific monoclonal antibodies on the test line and with a goat anti-rabbit antibody on the control line. During testing any antigens present react with the gold-marked monoclonal antibody and then move laterally on the membrane by capillary action. If the sample contains chlamydia antigens, a coloured line with a specific antibodychlamydia-antibody gold particle complex will form on the membrane in the test band region. If no chlamydia antigen is present, only a pink line appears in the control band region. For control purposes, a coloured line always appears in the control zone, whether chlamydia is present or not.

Packaging unit: 20 tests

Sensitivity: 1.0 x 105 germs
Specificity: > 99%
Shelf life: 24 months from date of manufacture
Storage temperature: +2ºC to +30ºC

Content of the kit:
• Single pouched test cassettes
• Extraction solution A
• Extraction solution B
• Sterilised swabs
• Extraction tubes with filter
• Reagent holder
• Instructions for use