Chlamydia Rapid Test Device (Swab/Urine)/Infectious Disease Diagnostic Kit

The Chlamydia Rapid Test Device (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.

* PRODUCT PICTURES 

* STORAGE AND STABILITY

The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.

The test must remain in the sealed pouch until use.

Do not freeze.

Care should be taken to protect the components of this kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipments, containers or reagents can lead to false results.

* MATERIALS

*Materials Provided

  Individually packed test devices  

  Extraction tubes & tips

  Reagent A Reagent B

  Package insert  

  Sterilized swabs 

  Workstation 

*Materials Required Not Provided

  Timer

* DIRECTIONS FOR USE

Allow the test, specimen, reagents, and/or controls to reach room temperature (15-30C) prior to testing.

1. Remove the test device 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 Endocervical or urethral swab specimens:

  Place a clean extraction tube in the workstation. Add 8 drops of reagent A 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 8 drops of reagent B. 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 8 drops of reagent A 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 B bottle upright and add 8 drops of Reagent B 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.

 * SPECIFICATION