Total IgE Rapid Test CE Marking


Product Number: RAPG-IGE-001

Pack size

20 tests

Product Description

The Biopanda Total IgE Rapid Test qualitatively detects human IgE antibodies in human whole blood, serum, and plasma. The test is intended for professional use to help diagnose allergy.

Principle

The Biopanda Total IgE Rapid Test is a qualitative, lateral flow immunoassay for the detection of human IgE antibody in whole blood, serum or plasma specimens. In this test, mouse anti-human IgE is coated in the test line region of the test. During testing, IgE present in whole blood, serum or plasma specimen reacts with mouse anti-human IgE coated particles in the test strip. The mixture then migrates laterally along the membrane by capillary action and reacts with the mouse anti-IgE on the membrane in the test line region. The presence of a coloured line in the test line region indicates a positive result for IgE, while its absence indicates a negative result for that infection. To serve as a procedural control, a coloured line will always appear in the control line region of the strip indicating that proper volume of specimen has been added and membrane wicking has occurred.

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 diagnosis of allergen

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 results will be obtained if the assay is performed within one hour.
  2. Place the cassette on a clean and level surface.
    • For Serum or Plasma specimens: Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 50 μl) to the specimen area and start the timer, see illustration below.
    • For Venipuncture Whole Blood specimen: Hold the dropper vertically and transfer 3 drops of whole blood (approximately 75 μl) to the specimen area, then add 1 drop of buffer (approximately 40 μl), and start the timer. See illustration below.
    • For Fingerstick Whole Blood specimen: Fill the capillary tube and transfer approximately 75 μl of fingerstick whole blood specimen to the specimen area of test cassette, then add 1 drop of buffer (approximately 40 μl) and start the timer. See illustration below.
  3. Wait for the coloured line(s) to appear. The test result should be read at 15 minutes. Do not interpret the result after 20 minutes.
HIV Rapid Test

Performance Characteristics

  • Relative sensitivity: 98.4%
  • Relative specificity: 98.7%

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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