CONTENT OF THE KIT
- Test cassette
- Reagent A + B
- Test tube
- Sterile swab
- 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
Swab discharge from the vaginal opening, then insert swab into vagina for half a minute and retrieve the swab.
Swab discharge from the opening of the urinary tract. If no discharge is present, insert the swab 2-3cm into the urinary tract, gently move a few turns and retrieve the swab.
C. Urine specimen
Collect 15mL urine specimen. Centrifuge the urine specimen 10 minutes with 10,000 rpm. Discard the supernate. Use the precipitate for detection. 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 6 drops of diluent A to the extraction tube. Place the specimen swab in the tube and twirl briefly to mix the reagent.
- Expunge as much liquid as possible from the swab by pressing and rotating the fiber portion against the wall of the tube. Discard the swab.
- Add 2 drops of diluent B to the extraction tube and mix well.
- Specimen collected in the diluent should be stored at 4-8°C and tested within 24 hours.
- In the case of urine specimen, use the tube with precipitate for detection. Add 6 drops of diluent A into the tube and mix well, then add 2 drops of diluent B and mix at least 10 seconds.
- 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 (Gonorrhea infection):
Colored lines are visible in the control region and the test region. The sample should be considered positive for Gonorrhea.
Negative (no infection):
One colored line is visible in the control region and no colored line in the test region.
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.