Chlamydia Rapid Test CE Marking


Product Number: RAPG-CLM-001

Pack size

20 tests

Product Description

The Biopanda Chlamydia Rapid Test qualitatively detects Chlamydia trachomatis in female cervical swab samples, male urethral swab samples, and male urine samples. The test is intended for professional use to help diagnose Chlamydia infections.

Test Attributes

  • Results available in only 10 minutes
  • Easy to use
  • Results can be read visually
  • No need for an analyser
  • Cost effective method for assisting in the diagnosis of Chlamydia Infections

Principle

The Biopanda Gonorrhea Rapid Test is a qualitative, lateral flow immunoassay for the detection of Gonorrhea antigen from female cervical and male urethral swab specimens. In the test, antibodies specific to the Gonorrhea antigen is coated on the test line region of the test. During testing, the extracted antigen solution reacts with an antibody to Gonorrhea that is coated onto particles. The mixture migrates laterally to react with the antibody to Gonorrhea on the membrane and generates a coloured line in the test region. The presence of this coloured line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a coloured line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

Test Procedure

  1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible. Best result 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 extraction reagent 1 bottle vertically and add 5 drops of reagent 1 (approx. 300 μl) to the extraction tube. Extraction reagent 1 is colourless. Immediately insert the swab, compress the bottom of the tube and rotate the swab 15 times. Let it stand for 2 minutes.
    • Hold the extraction reagent 2 bottle vertically and add 6 drops of extraction reagent 2 (approx. 250 μl) to the extraction tube. The solution will turn turbid. Compress the bottom of the 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 colour will turn yellow or brown. Let it 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:
    • Hold the extraction reagent 2 bottle vertically and add 6 drops of (approx. 250 μl) reagent 2 to the urine pellet in the centrifuge tube, then shake the tube vigorously until the suspension is homogeneous.
    • Transfer all the solution in the centrifuge tube to an extraction tube. Let it stand for 1 minute. Hold the extraction reagent 1 bottle upright and add 5 drops of (approx. 300 μl) extraction reagent 1 to the extraction tube. Vortex or tap the bottom of the tube to mix the solution. Let it stand for 2 minutes.
    • 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. 100 μl) to the sample well of the test cassette, then start the timer. Avoid trapping air bubbles in the sample well.
  4. Wait for the colour to appear. Read the result at 10 minutes. Do not interpret the result after 20 minutes.
test procedure drawing


Performance characteristics


Specimen Sensitivity Specificity Accuracy
Female Cervical Swab Specimens 93.3% 97.5% 96.6%
Male Urethral Swab Specimens 86.2% 95.8% 92.7%
Male Urine Specimens 94.6% >99.9% 97.9%


Storage Conditions

Store the kit between 2-30°C and ensure the kits are not frozen or stored in direct sunlight. The test is valid until the expiration date printed on the foil wrapping.



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