Chlamydia and Gonorrhea Rapid Test

A rapid test for the qualitative detection of Gonorrhea and Chlamydia antigen in female cervical swab and male urethral swab specimens.
For professional in vitro diagnostic use only.
PocTell^® Chlamydia and Gonorrhea Rapid Test Combo Cassette is a rapid chromatographic immunoassay for the qualitative detection of Neisseria gonorrhoeae and Chlamydia trachomatis in female cervical swab and male urethral swab specimens to aid in the diagnosis of Gonorrhea and Chlamydia infection.

PocTell^® Chlamydia and Gonorrhea Rapid Test Combo Device is a qualitative, lateral flow immunoassay for the detection of Chlamydia and Gonorrhea antigen from clinical specimens.
In this test, antibody specific to the Chlamydia/Gonorrhea antigen is coated on the test line region of the strip. During testing, the extracted antigen solution reacts with an antibody to Chlamydia/Gonorrhea that is coated onto particles. The mixture migrates up to react with the antibody to Chlamydia/Gonorrhea on the membrane and generate a red line in the test region. The presence of this red line in the test region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a red line will always appear in the control region indicating that proper volume of specimen has been added and membrane wicking has occurred.

Allow the test device, specimen, reagents, and/or controls to reach room temperature (15-30℃) 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:
For Female Cervical or Male Urethral Swab Specimens:

• Hold the Reagent A bottle vertically and add 6 full drops of Reagent A (approximately 240 µL) to the extraction tube(See illustration ①). Reagent A is colorless. Immediately insert the swab, compress the bottom of the tube and rotate the swab 15 times. Let stand for 1 minutes. (See illustration ②)
• Hold the Reagent B bottle vertically and add 6 full drops Reagent B (approximately 240ul) to the extraction tube. (See illustration ③) Reagent B is pale yellow. The solution will turn cloudy. Compress the bottom of tube and rotate the swab 15 times until the solution turns to a clear color with a slight green or blue tint. If the swab is bloody, the color will turn yellow or brown. Let stand for 1 minute. (See illustration ④)
• Press the swab against the side of the tube and withdraw the swab while squeezing the tube. (See illustration ⑤).Keep as much liquid in the tube as possible. Fit the dropper tip on top of the extraction tube. (See illustration ⑥)

For Male Urine Specimens:

• Hold the Reagent B bottle vertically and add 6 full drops Reagent A (approximately 240ul) to the urine pellet in the centrifuge tube, then shake the tube vigorously mix 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 A bottle upright and add 6 full drops of Reagent B (approximately 240 µL) then add 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.
•  Place the test device on a clean and level surface. Add 2-3 full drops of extracted solution (approximately 80-120 µL) to the specimen well (S) of the test device, then start the timer. Avoid trapping air bubbles in the specimen well (S).
• Wait for the red line(s) to appear. Read the result at 10 minutes. Do not read the result after 20 minutes.

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