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Principle

It is a qualitative, lateral flow immunoassay for the detection of Chlamydia antigen from clinical specimens. In this test, antibody specific to the Chlamydia antigen is coated on the test line region of the strip. During testing, the extracted antigen solution reacts with an antibody to Chlamydia that is coated onto particles. The mixture migrates up to react with the antibody to Chlamydia on the membrane and generate a red line in the test region.

Precautions

Please read all the information in this package insert before performing the test.

● For professional in vitro diagnostic use only. Do not use after expiration date.
● Do not eat, drink or smoke in the area where the specimens and kits are handled.
● Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens.
● Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
● Humidity and temperature can adversely affect results.
● Use only sterile swabs to obtain endocervical specimens.
● Tindazole vaginal effervescent tablets and Confort Pessaries with negative specimens may cause very weak interference effect.

Directions For Use

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:
Hold the Reagent A bottle vertically and add 4 full drops of Reagent A (approximately 280µL) 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 2 minutes. (See illustration ②)

Hold the Reagent B bottle vertically and add 4 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 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.

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 280 µL) 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.

POSITIVE RESULT:
* A colored band appears in the control band region (C) and another colored band appears in the T band region.

NEGATIVE RESULT:
One colored band appears in the control band region (C). No band appears in the test band region (T).

INVALID RESULT:
Control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
*NOTE: The intensity of the red color in the test line region (T) may vary depending on the concentration of Chlamydia antigen presents in the specimen. Therefore, any shade of red in the test region (T) should be considered positive.