Chlamydia Ag Rapid Test Device (Swab) - Self-Collected Swab for Early Detection
The Chlamydia Ag Rapid Test Device (Swab) is an in vitro diagnostic rapid test designed for the direct detection of Chlamydia trachomatis antigen in urogenital swab samples. Utilizing immunochromatographic assay technology, this test provides visual results within minutes, serving as an aid in the preliminary diagnosis of chlamydial infections.
Detection Principle and Target
This antigen detection test employs specific antibodies immobilized on a nitrocellulose membrane to capture Chlamydia trachomatis antigens, if present in the patient's swab sample. The test targets specific proteins or lipopolysaccharides from the bacterial cell wall/elementary bodies, indicating an active, current infection at the site of sampling.
Intended Use and Clinical Application
The test is intended for the rapid, qualitative detection of Chlamydia trachomatis antigen. Its primary application is for preliminary screening and diagnosis of genital chlamydia infections. It is particularly useful in point-of-care settings such as clinics and community health programs where quick results can guide immediate counseling and treatment decisions, helping to control transmission.
Key Features and Advantages
- Direct Detection of Active Infection: Detects the pathogen itself, confirming a current infection rather than a past immune response
- Rapid Results: Provides visual results typically within 10-20 minutes, enabling swift clinical management
- High Clinical Utility for Screening: Effective for screening both symptomatic and asymptomatic individuals, which is crucial as chlamydia infections are often silent
- Simple Procedure: The process involves collecting a swab, processing it with extraction buffer, and applying it to the test device with no complex instrumentation required
Specimen Type and Procedure
Specimen: Urogenital swab (endocervical swab for women, urethral swab for men, or possibly vaginal swabs as per device instructions).
Procedure: The swab sample is eluted into the provided extraction buffer solution. Drops of the processed sample are then added to the sample well of the test device. Results are read after the specified time.
Interpretation of Results
Positive Result: Appearance of both Control line (C) and Test line (T) indicates detection of Chlamydia trachomatis antigen.
Negative Result: Appearance of only the Control line (C) indicates no antigen was detected at a level above the test's threshold.
Invalid Result: If the Control line (C) does not appear, the test is invalid and must be repeated with a new device.
Clinical and Public Health Significance
Early detection and treatment of chlamydia are vital to prevent serious complications such as pelvic inflammatory disease (PID), infertility, and ectopic pregnancy in women, and epididymitis in men. This rapid test facilitates early intervention, helps break the chain of transmission, and is a valuable tool in public health initiatives aimed at controlling the spread of this common sexually transmitted infection (STI).
Important Notes
This test is designed as an aid in diagnosis. While a positive result is highly indicative of infection, confirmatory testing using an alternative method (e.g., Nucleic Acid Amplification Test - NAAT) may be recommended in certain clinical or low-prevalence settings, as per local guidelines. A negative result does not completely rule out infection; if clinical suspicion remains high, retesting with a more sensitive NAAT is advised. Proper specimen collection technique is critical for an accurate result.
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