CE0123 Chlamydia Antigen Rapid Test Female Cervical Swab Women's Health Test Kit

Chlamydia Rapid Test, Detect the Chlamydia antigen from female cervical swab

Description:

The Chlamydia Rapid Test Cassette (Swab/Urine) is a qualitative, lateral flow immunoassay for the detection of Chlamydia antigen from female cervical, male urethral and male urine. In the test, antibody specific to the Chlamydia antigen is coated on the test line region of the test. During testing, the extracted antigen solution reacts with an antibody to Chlamydia that is coated onto particles.

The mixture migrates up to react with the antibody to Chlamydia on the membrane and generates a color line in the test region. The presence of this colored line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

How to use?

Allow the test, reagents, swab specimen, and/or controls to reach room temperature (15-30℃)

1. Remove the test cassette from the foil pouch and use it within one hour. 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 Cervical or Male Urethral Swab Specimens:
 

· Hold the reagent 1 bottle vertically and add 5 drops of reagent 1 (approx. 300ul) to the extraction tube. Reagent 1 is colorless.

Immediately insert the swab, compress the bottom of tube and rotate swab 15 times. Let stand for 2 minutes.
 

· Hold the reagent 2 bottle vertically add 6 drops of reagent 2 (approx. 250ul) to the extraction tube. The solution would turn turbid. Compress the bottle of tube and rotate the swab 15 times until the solution turn clear with a slight green or blue tint. If the swab is bloody, the color will turn yellow or brown. Let stand 1 minute.
 

· Press the swab against the side of tube and withdraw the swab while squeezing the tube. Keep as much liquid in the tube as possible. Fit the dropper tip on top of extraction tube.
 

· For Male Urine Specimens:
 

· Hold the reagent 2 bottle vertically and add 6 drops of (approx. 250ul) reagent 2 to the urine pellet in the centrifuge tube, then shake the tube vigorously until the suspension is homogeneous.
 

· Transfer all the solution in the centrifuge tube to an extraction tube. Let stand for 1 minute. Hold the reagent 1 bottle upright and add 5 drops of (approx. 300ul) reagent 1 to the extraction tube.
Vertex or tap the bottom of the tube to mix the solution. Let stand for 2 minutes.
 

· Fit the dropper tip on top of the extraction tube.
 

3. Place the test cassette on a clean and level surface. Add 3 full drops of the extracted solution (approx. 100ul) to the specimen well of the test cassette (S), then start the timer. Avoid trapping air bubbles in the specimen well.
 

4. Wait for the color to appear. Read the result at 10 minutes, do not interpret the result after 20 minutes.
Note: It is suggested not to use the extraction reagent, beyond 6 months after opening the vial.

INTERPRETATION OF RESULTS
(Please refer to the illustration above)
POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T). A positive result indicates that Chlamydia was detected in the specimen.

*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of Chlamydia present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T). A negative result indicates that Chlamydia antigen is not present in the specimen, or is present below the detectable level of the test.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.