Gonorrhea Rapid Test CE Marking


Product Number: RAPG-GON-001

Pack size

20 tests

Product Description

The Biopanda Gonorrhea Rapid Test qualitatively detects Neisseria gonorrhoeae in female cervical swab and male urethral swab specimens. The test is intended for professional use to help diagnose Gonorrhea infections.

Test Attributes

  • Whole Blood, Serum or plasma samples may be used for testing
  • Results available in only 15 minutes
  • Easy to use
  • Results can be read visually
  • No need for an analyser
  • Cost effective method for assisting in the detection of Chikungunya 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. Remove the test cassette from the seal 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 Gonorrhea antigen according to the specimen type.
  3. Hold the reagent 1 bottle vertically and add 5 drops of reagent 1 (approx. 300 μl) to an extraction tube. Reagent 1 is colourless. Immediately insert the swab, compress to the bottom of the tube and rotate the swab 15 times. Let it stand for 2 minutes.
  4. Hold the reagent 2 bottle vertically and add 4 drops of reagent 2 (approx. 200 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.
  5. Press the swab against the side of 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 extraction tube.
  6. Place the test cassette on a clean and level surface. Add 3 full drops of the extracted solution (approx. 100 μl) to the specimen well of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well.
  7. Wait for the coloured line(s) to appear. Read the result at 10 minutes. Results read after 30 minutes are considered invalid.
test procedure drawing


Performance characteristics


Specimen Sensitivity Specificity Accuracy
Female Cervical Swab Specimens 94.4% 96.9% 95.9%
Male Urethral Swab Specimens 91.6% 97.1% 94.3%


Storage Conditions

+2 - 30 °C




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