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MONO Rapid Test CE Marking


Product Number: RAPG-MONO-001

Pack size

20 tests

Product Description

The Biopanda MONO Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood, serum, and plasma samples. This test is a tool to assist in the diagnosis of Infectious Mononucleosis (IM).

Test Attributes

  • Whole blood, serum, or plasma samples may be used for testing
  • Results available in only 5 minutes
  • Easy to use
  • Results can be read visually
  • No need for an analyser
  • Cost effective method for assisting in the diagnosis of Infectious Mononucleosis

Test Procedure

  1. Ensure specimen and test kits are brought to room temperature before testing. Ensure the blood specimen is mixed well.
  2. Open the foil wrapped pouch and remove the cassette, placing it on a flat, clean surface. Use the test as soon as possible or within one hour of opening.
  3. Hold the dropper vertically and transfer the required drops of the sample to the sample well on the cassette, then add 1 drop of buffer and start the timer.
  4. Wait for the coloured line(s) to appear. Read results at 5 minutes.  Do not interpret the result after 10 minutes.
MONO Rapid Test

Principle

The Biopanda MONO Rapid Test is a qualitative, lateral flow immunoassay for the detection of IM heterophile antibodies in whole blood, serum, or plasma. In this test, bovine erythrocyte extracted antigen is immobilized in the test line region of the test. During testing, the specimen reacts with bovine erythrocyte extracted antigen coated particles that have been applied to the labelled pad. This mixture migrates chromatographically along the length of the test and interacts with the immobilized bovine erythrocyte extracted antigen. If the specimen contains IM heterophile antibodies, a coloured line will appear in the test line region, indicating a positive result. If the specimen does not contain IM heterophile antibodies, a coloured line will not appear in this region indicating 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.

Performance Characteristics

  • Relative sensitivity: >99.9%
  • Relative specificity: 98.9%

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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