Chlamydia
The NADAL® Chlamydia Test (swab/urine) is a rapid visual immunoassay for the qualitative presumptive detection of Chlamydia trachomatis in female cervical swab, male urethral swab and male urine specimens. This test is intended for use as an aid in the diagnosis of Chlamydia infection. The NADAL® Chlamydia Test is designed for professional use only.
The genera Chlamydia and Chlamydophila include, among others, three species: Chlamydia trachomatis (C. trachomatis), the recently reclassified Chlamydophila pneumoniae (C. pneumoniae), primarily associated with humans, as well as Chlamydia psittaci (C. psittaci), primarily associated with animals.
C. trachomatis comprises 15 known serovars and is associated with trachoma and genitourinary infections. 3 out of 15 serovars are associated with lymphogranuloma venereum (LGV). C.trachomatis infections are the most common sexually transmitted bacterial diseases. C. trachomatis infection is characterised by 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 diseases (PID) and increased incidence of ectopic pregnancies and infertility. Vertical transmission of the disease during parturition from mother to neonate can result in inclusion conjunctivitis and pneumonia. In men, at least 40% of cases of nongonococcal urethritis are associated with Chlamydia infection and epididymitis. Approximately 70% of women with endocervical infections and up to 50% of men with urethral infections are symptomatic.
C. psittaci infection is associated with respiratory diseases in individuals exposed to infected birds and is not transmitted from human to human.
C. pneumoniae, first isolated in 1983, is associated with respiratory infections and pneumonia.
Earlier Chlamydia infection has been diagnosed by the detection of Chlamydia inclusions in tissue culture cells. Culture method is the most sensitive and specific laboratory method, but it is labour-intensive, expensive, lengthy (2-3 days) and not routinely available in most institutions. Direct tests such as immunofluorescence assays (IFA) require specialised equipment and a skilled operator to read the result. Today Chlamydia are frequently detected by PCR.
The NADAL® Chlamydia Test (swab/urine) detects Chlamydia trachomatis through visual interpretation of colour development on the internal test strip. Antigen-specific lipopolysaccharide (LPS) monoclonal antibody is immobilised in the test line region of the membrane. During testing, the specimen reacts with other monoclonal anti-Chlamydia-LPS antibodies conjugated to coloured particles and precoated onto the conjugate pad of the test. The mixture then migrates along the membrane by capillary action and interacts with reagents on the membrane. If there are sufficient Chlamydia antigens in the specimen, a coloured line will appear in the test line region of the membrane. The presence of this coloured line indicates a positive result, while its absence indicates a negative result.
The appearance of a coloured line in the control line region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
