Gonorrhea and Chlamydia Combo Rapid Test Cassette (Swab)

A rapid test for the qualitative detection of Gonorrhea and Chlamydia antigen in female cervical swab and male urethral swab specimens

1 box has 10 tests

For Export Only

The Gonorrhea and Chlamydia Combo Rapid Test Cassette (Swab) is a qualitative, lateral flow immunoassay for the detection of Neisseria gonorrhoeae and Chlamydia trachomatis in female cervical and male urethral swab specimens.

In the test, antibodies specific to the Gonorrhea and Chlamydia antigen is coated on the test line region of the test. During testing, the extracted antigen solution reacts with antibodies against Gonorrhea and Chlamydia antigens that is coated onto particles. The mixture migrates up to react with the antibodies against Gonorrhea and Chlamydia antigens on the membrane and generates a color line in the test region.

The presence of this colored line in the test line region (T) of gonorrhea indicates a positive result for gonorrhea and the presence of a colored line in the test line region (T) of chlamydia indicates a positive result for chlamydia.

The absence of a colored line in either test line region for gonorrhea or test line region for chlamydia indicates a negative result for the respective organism. 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.

Materials provided:

• Test Cassettes
• Extraction Tubes
• Extraction Reagent 1 (0.2M NaOH)
• Sterile Female Cervical Swabs
• Extraction Reagent 2 (0.2 M HCl)
• Workstation
• Package Insert
• Dropper Tips

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

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 Specimen:
• 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 the 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 turns 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 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 each specimen wells of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well.
   
   
4. Wait for the colored line(s) to appear. Read the result at 10 minutes; do not interpret the result after 20 minutes. Note: It is recommended to use the buffer within 6 months after opening the vial.

POSITIVE for Gonorrhea:* Two colored lines appear in the Gonorrhea window. One line should be in the control line region (C) and another line should be in the test line region (T) in the Gonorrhea window.

POSITIVE for Chlamydia:* Two colored lines appear in the Chlamydia window. One line should be in the control line region (C) and another line should be in the test line region (T) in the Chlamydia window.

POSITIVE for Gonorrhea and Chlamydia:* Two colored lines appear in both windows. One line should be in the control line region (C) and another line should be in the test line region (T) in both of Gonorrhea and Chlamydia windows.

*NOTE: The shade of color in the test line region (T) may vary, but it should be considered positive whenever there is even a faint colored line.

NEGATIVE for Chlamydia and Gonorrhea: Only colored lines appear in the control line regions (C) of both Gonorrhea and Chlamydia windows. No apparent colored line appears in the test line region (T) of either Gonorrhea or Chlamydia window.

INVALID: No line appears in the control line region (C). If this occurs, read the directions again and repeat the test with a new test. If the result is still invalid, stop using the test kit immediately and contact your local distributor.