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D-dimer Rapid Tests CE Marking


Biopanda Reagents offers two types of Rapid Tests for D-dimer as follows:

Quantitative D-dimer Rapid Test

Product Number: RAPG-DD-001

Pack size

25 tests

Product Description

This Point-of-Care rapid test, based on colloidal gold immunochromatography, is designed to detect D-dimer in serum, plasma and whole blood samples quantitatively. Results are available in 10-20 minutes, which assists health professionals to diagnose and treat Deep Vein Thrombosis (DVT) and Pulmonary Embolism. This test is intended to be used with the FIA8000 Quantitative Immunoassay Analyzer.

Test Attributes

  • Whole blood or plasma may be used for testing
  • Results available in only 10-20 minutes
  • Easy to use
  • Cost effective method for identifying DVT and Pulmonary Embolism

Test Procedure

  1. Using a pipette, take 80 μl of the plasma or whole blood sample and add to one blood sample diluent tube and mix gently and thoroughly.
  2. Drop 120 μl of the solution into the sample well.
  3. Wait for 7 minutes and then load the cassette into the FIA8000. Follow the instructions laid out in the FIA8000 User's manual for reading cassettes. Quantitative results will be printed automatically.
FIA8000 Analyser D-dimer

Storage Conditions

+4 - 30 °C

Qualitative D-dimer Rapid Test

Product Number: RAPG-DD-002

Pack size

20 tests

Product Description

The Biopanda D-dimer Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of human D-dimer in  whole blood and plasma samples. This test is a tool to assist in the diagnosis of Disseminated Intravascular Coagulopathy (DIC), deep venous thrombosis (DVT) and pulmonary embolism (PE).

Test Attributes

  • Whole blood or plasma may be used for testing
  • Results available in only 10 minutes
  • Easy to use
  • Qualitative results can be read visually
  • No need for an analyser
  • Cost effective method for identifying myocardial ischemia, myocardial infarction, and ACS

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. For Plasma samples:
    Hold the dropper vertically and transfer 1 drop of plasma (approximately 25 μl) to the specimen area, then add 2 drops of buffer (approximately 80 μl), and start the timer.
  4. For Venipuncture Whole Blood specimens:
    Hold the dropper vertically and transfer 1 drop of whole blood (approximately 25 μl) to the specimen area, then add 2 drops of buffer (approximately 80 μl), and start the timer.
  5. For Fingerstick Whole Blood specimens:
    To use a capillary tube: Fill the capillary tube and transfer approximately 25 μl of fingerstick whole blood specimen to the specimen area of the test cassette, then add 2 drops of buffer (approximately 80 μl) and start the timer.
    To use hanging drops: Allow 1 hanging drop of fingerstick whole blood specimen (approximately 25 μl) to fall into the specimen area of the test cassette, then add 2 drops of buffer (approximately 80 μl) and start the timer.
  6. Wait for the coloured line(s) to appear. Read results at 10 minutes.  Do not interpret the result after 20 minutes.
D-dimer

Performance Characteristics

  • Relative sensitivity: 99.9%
  • Relative specificity: 98.2%
  • Accuracy: 98.4%

Storage Conditions

+2 - 30 °C



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