Chlamydia Rapid Test Cassette to Test Swab/Urine Sample Device Kit

• Type: IVD Reagent
• Component: Rapid Test + Buffer + Swab
• Specimen: Urine or Endocervical Swab
• Result Time: Within 5 Mins
• Storage: 2~30 º C
• Principle: Immunochromatography
• Model NO.: CHL
• Shelf Life: 24 Months
• Transport Package: 25tests/Box
• Specification: 1000tests/carton
• Trademark: Dewei
• Origin: China

Product Description

Storage	2~30 º C
Specimen	Urine Endocervical Canal Swab
Component	Rapid Test + Extraction Buffer + Swab
Principle	Colloidal gold rapid tests
Reading	Within 5mins
Package	25tests/box
Trademark	Dewei
Origin	China

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.

INTERPRETATION OF RESULTS
Positive (+)
Two colored bands appear on the membrane. 
Negative (-)
Only one colored band appears, in the control region (C).  
Invalid
Control band fails to appear. 

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