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Ferritin Rapid Test CE Marking


Product Number: RAPG-FER-001

Pack size

20 tests

Product Description

The Biopanda Ferritin Semi-Quantitative Rapid Test is a chromatographic immunoassay for the semi-quantitative detection of human ferritin in human whole blood, serum or plasma samples at a cut-off concentration of 30 ng/ml for males and 13 ng/ml for females. This test may be used as an aid in the detection of iron deficiency anaemia and other health issues.

Principle

The Biopanda Ferritin Semi-Quantitative Rapid Test is a semi-quantitative, lateral flow immunoassay for the detection of human ferritin in human whole blood, serum or plasma samples. The membrane is pre-coated with anti-ferritin polyclonal antibodies on the test line region. The membrane is precoated with Goat anti Rabbit IgG on the reference line region. The gold is pre-coated with anti-ferritin monoclonal antibody and Rabbit IgG. During testing, the specimen reacts with the particle coated with anti-ferritin monoclonal antibody. The mixture migrates laterally along the membrane chromatographically by capillary action to react with anti-ferritin polyclonal antibodies on the membrane and generates a coloured line. The line in test line region (T) is darker than the line in the reference line region (R), if the ferritin level exceeds the cut-off level of 30 ng/ml. If the ferritin concentration is less than 30 ng/ml, but more than 13 ng/ml, the Test line (T) intensity would be less than the Reference line (R). To serve as a procedural control, a coloured line will always appear in the control line region, indicating that the 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 5 minutes
  • Easy to use
  • Results can be read visually
  • No need for an analyser
  • Cost effective method for assisting in the diagnosis of iron deficiency anaemia

Test Procedure

  1. Ensure specimen and test kits are brought to room temperature before testing. Ensure the blood specimen is mixed well.
  2. Remove the cassette from the sealed pouch and use it within one hour. Place the cassette on a clean and level surface.
  3. For Serum or plasma specimens:
    Hold the dropper vertically and transfer 1 full drop of serum or plasma (approximately 25 μl) to the specimen well of the cassette, then add 1 drop of buffer (approximately 40 μl) and start the timer. Avoid trapping air bubbles in the specimen well. See illustration below.
  4. For Whole blood specimens:
    For Venipuncture Whole Blood specimens:
    Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50 μl) to the specimen well, then add 1 drop of buffer (approximately 40 μl), and start the timer. See illustration below.
    For Fingerstick Whole Blood specimens:
    To use a capillary tube: Fill the capillary tube and transfer approximately 50 μl of fingerstick whole blood specimen to the specimen well of test cassette, then add 1 drop of buffer (approximately 40 μl) and start the timer. See illustration below.
  5. Wait for the coloured line(s) to appear. Read the result at 5 minutes. Results read after 10 minutes are considered invalid.



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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