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Alpha-Fetoprotein Rapid Test CE Marking


Product Number: RAPG-AFP-001

Pack size

20 tests

Product Description

The Biopanda AFP Rapid test qualitatively detects for the presence of Alpha-Fetoprotein in human whole blood, serum, or plasma samples. This test applies lateral flow immuno-chromatography and is for professional in vitro diagnostic use.

Test Attributes

  • Whole Blood, Serum, or Plasma samples may be used for testing
  • 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 detection of Hepatocellular Carcinoma or foetal open neural tube defects

Test Procedure

  1. Ensure specimen and test kits are brought to room temperature before testing.
  2. Open the foil wrapped pouch and remove the cassette. Place the cassette on a flat, clean surface. Use test immediately after opening.
  3. Using a dropper provided transfer 2 drops of the whole blood or 1 drop of the serum or plasma to the sample well on the cassette. Then add 1 drop of buffer.
  4. Read results at 10 minutes.
  5. Results read after 20 minutes are considered invalid. Dispose of the cassette safely after testing.
AFP rapid test

Principle

The Biopanda AFP Rapid Test is a qualitative membrane based immunoassay for the detection of AFP in whole blood, serum or plasma. The membrane is pre-coated with anti-AFP antibodies on the test line region. During testing, the specimen reacts with the particle coated with anti-AFP antibodies. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-AFP antibodies on the membrane and generate a coloured line. 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. 

Performance Characteristics

  • Relative sensitivity: 99.4%
  • Relative specificity: 99.0%
  • Accuracy: 99.2%

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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