CONTENT OF THE KIT
- Test cassette
- Reagent A + B
- Test tube
- 2 sterile swabs
- Carefully follow the instructions exactly.
- Only use supplied materials.
- Wash the hands thoroughly to avoid contamination of the specimen. Contamination may cause erroneous result.
- This kit is for in vitro use only. Do not swallow.
- Discard after first use. The test can only be used once.
- Do not use test kit beyond the expiration date.
- Do not use the kit if the pouch is punctured or not well sealed.
- Keep out of children's reach.
STORAGE AND STABILITY
- Store at 4°C to 30°C in the sealed pouch up to expiration date.
- Keep away from sunlight, moisture and heat.
- Use the test shortly after opening the pouch.
SPECIMEN COLLECTION AND PREPARATION
A. Endocervical sample (Females)
- Remove any excess mucus from the potentially infected site with the first swab, and then discard it.
- Insert the second swab into the endocervical canal until most of the tip is no longer visible, Rotate the swab for 15-30 seconds. Carefully withdraw the swab without touching the vaginal surface.
B. Endourethral sample (Males)
- Insert the swab into the urethra of the penis and rotate for 3-5 seconds and withdraw.
C. Urine specimen
Collect 20-40 mL urine specimen. First morning specimens are preferred. Although urine specimen is workable, the swab specimen is more recommended for higher sensitivity.
- When the test have been stored in a cold room, wait for it to reach room temperature (10 - 30°C).
- Add 5 drops of reagent A to the extraction tube. Place the specimen swab in the tube and swirl thoroughly for 10 seconds. Leave at room temperature (10°-30°C) for 5 minutes, with the swab in the tube.
- Swirl the swab 2-3 times for a few seconds during the extraction step, pressing it against the wall of the tube to expel the liquid and insure thorough contact of reagents and specimen.
- At the end of the 5 minutes, thoroughly remove as much extract from the swab as possible by raising it above the liquid level and squeezing the extraction tube.
- Remove swab and then add 5 drops of reagent B.
- The extract can remain at room temperature for up to 30 minutes without affecting the test results.
- In the case of urine specimen, centrifuge the sample and use the tube with precipitate for detection. Add 5 drops of reagent A into the tube and mix well. After 5 minutes, add 5 drops of reagent B and mix well.
- Remove the test cassette from its sealed foil pouch by tearing at the notch. Dispense 4 drops of liquid from the extraction tube into the sample well of the test device by inverting and squeezing the tube as shown.
HOW TO INTERPRET THE RESULT
Results can be read at 10-15 minutes. Do not read the result after 15 minutes. 15 minutes should be allowed to confirm a negative result.
There is no meaning attributed to line color intensity or width.
Positive (Chlamydia infection):
Colored lines are visible in the control region and the test region. The sample should be considered positive for Chlamydia trachomatis.
Negative (no infection):
One colored line is visible in the control region and no colored line in the test region. The sample should be considered negative for Chlamydia trachomatis.
No visible band at all, or there is a visible band only in the test region but not in the control region. The most common reason for this is that the instructions have not been followed exactly.