Chlamydia Rapid Test Cassette
1. Product Details
Test Name: The Chlamydia Rapid Test Cassette
Test Item: Chlamydia Trachomatis
Specimen: Female cervical swab, male urethral swab and male urine specimens
The Chlamydia Rapid Test Cassette (Swab/Urine) is a qualitative, lateral flow immunoassay for the detection of Chlamydia antigen from female cervical swab, male urethral swab and male urine specimens. In this test, antibody specific to the Chlamydia antigen is coated on the test line region of the test. 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 colored line in the test line region. The presence of this colored line in the test line region indicates a positive result, while its absence indicates a negative result. 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.
3. Materials Provided
(1) Test devices
(2) Test tubes
(3) Dropper tips
(4) Sterile female cervical swabs
(5) Reagent A (0.2M NaOH)
(6) Reagent B (0.2N HCl)
(7) Package insert
(9) Quantitative pipette
4. Directions for Use
Allow the test, 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 according to the specimen type.
For Female Cervical or Male Urethral Swab Specimens:
-Hold the Reagent A bottle vertically and add 5 full drops of Reagent A (approximately 300 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.
-Fill the quantitative pipette for Reagent B up to the marked line (approximately 220 µL) then add the Reagent B to the extraction tube. 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.
-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:
-Fill the quantitative pipette for Reagent B to the marked line (approximately 220 µL) then add the Reagent B to the urine pellet in the centrifuge tube, then draw the liquid up and down with a pipette to 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 5 full drops of Reagent A (approximately 300 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 the 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 colored line(s) to appear. Read the result at 10 minutes. Do not interpret the result after 20 minutes.
Hangzhou Laihe Biotech Co., Ltd
Address: Room 521 Floor 5 & Floor 1,Building No. 2B,Tianhe High-Tech Park,No. 688,Bin'an Road,Changhe Sub-district,Binjiang District,Hangzhou City,Zhejiang Province,China