Allow the test device, specimen, reagents, and/or controls to reach room temperature (15-30°C) 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:
1.Hold the Reagent A bottle vertically and add 4 full drops of Reagent A (approximately 280 µL) to the extraction tube. Reagent A is colorless. Immediately insert the swab, compress the bottom of the tube and rotate the swab 15 times. Let stand for 2 minutes.
2.Hold the Reagent B bottle vertically and add 4 full drops Reagent B (approximately 240ul) to the extraction tube. 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.
3.Press the swab against the side of the 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.
For Male Urine Specimens:
1.Hold the Reagent B bottle vertically and add 4 full drops Reagent B (approximately 240ul) to the urine pellet in the centrifuge tube, then shake the tube vigorously mix until the suspension is homogeneous.
2.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 4 full drops of Reagent A (approximately 280µL) then add to the extraction tube. Vortex 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 device on a clean and level surface. Add 3 full drops of extracted solution (approximately 100 µL) to the specimen well (S) of the test device, then start the timer. Avoid trapping air bubbles in the specimen well (S).
4. Wait for the red line(s) to appear. Read the result at 10 minutes. Do not read the result after 20 minutes.