One Step Chlamydia Rapid Test Cassette to Test Swab/Urine Sample
Device Kit
INTENDED USE
The Chlamydia Rapid 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 kit is intended for use as an aid in the diagnosis
of Chlamydia infection.
PRINCIPLE
The Chlamydia Rapid Test detects Chlamydia trachomatis through visual interpretation of color development on the internal
strip. Antigen-specific lipopolysaccharide (LPS) monoclonal
antibody is immobilized on the test region of the membrane. During
testing, the specimen reacts with monoclonal anti-Chlamydia
antibodies conjugated to colored particles and precoated onto the
sample pad of the test. The mixture then migrates through the
membrane by capillary action and interacts with reagents on the
membrane. If there is sufficient chlamydia antigen in the specimen,
a colored band will form at the test region of the membrane. The
presence of this colored band indicates a positive result, while
its absence indicates a negative result. The appearance of a
colored band at the control region serves as a procedural control,
indicating that the proper volume of specimen has been added and
membrane wicking has occurred.
OPERATION
Allow the test, specimen, reagents, and/or controls to reach room
temperature (15-30°C) prior to testing.1. Remove the test cassette from the sealed foil pouch and use it
as soon as possible. Best results will be obtained if the test is
performed immediately after opening the foil pouch.
2. Extract the Chlamydia antigen according to the specimen type.
For Female endocervical or Male urethral swab specimens:
• Place a clean extraction tube in the workstation. Add 5 drops of
Ragent 1 to the extraction tube.
• Immerse the patient swab into the extraction tube and wait 2
minutes. While waiting, use a circular motion to roll the swab
against the side of the extraction tube so that the liquid is
expressed from the swab and can reabsorb.
• Add 6 drops of Reagent 2. Squeeze the swab firmly against the tube
to expel as much liquid as possible from the swab for 1 minute.
Discard the swab following guidelines for handling infectious
agents. Fit the dropper tip on top of the extraction tube.
• The extracted specimen can remain at room temperature for 60
minutes without affecting the test result.
For Male urine specimens:
• Add 6 drops of Reagent 2 to the urine pellet in the centrifuge
tube, then draw the liquid up and down with a pipette to vigorously
mix until the suspension is homogeneous.
• Transfer all the solution in the centrifuge tube to an extraction
tube. Let stand for 2 minute. Hold the Reagent 2 bottle upright and
add 5 drops of Reagent 1 to the extraction tube. Vortex or tap the
bottom of the tube to mix the solution. Let stand for 1 minutes.
• Fit the dropper tip on top of the extraction tube.3. Add 3 drops (approximately 100 µL) of extracted specimen from
the extraction tube to the specimen well (S) of the test cassette.
Avoid trapping air bubbles in the specimen well (S), and do not add
any solution to the result window.
As the test begins to work, color will migrate across the membrane.4. Wait for the colored band(s) to appear. The result should be read
at 10 minutes. Do not interpret the result after 20 minutes.