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Dengue IgG/IgM Rapid Test CE Marking


Product Number: RAPG-DEN-001

Pack size

20 tests

Product Description

The Biopanda Dengue IgG/IgM Rapid Test Cassette is a rapid immunochromatographic assay for the qualitative detection of IgG and IgM antibodies to Dengue virus in human whole blood, serum, or plasma samples to aid in the diagnosis of primary and secondary Dengue infections.

Test Attributes

  • Whole blood, serum, or plasma 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 to diagnose Dengue infections

Test Procedure

  1. Ensure specimen and test kits are brought to room temperature before testing. Ensure the specimen is mixed well.
  2. Open the foil wrapped pouch and remove the cassette. Use the test as soon as possible or within one hour of opening.
  3. Transfer sample to the specimen well of the cassette, then add 1 drop of buffer and start the timer.
  4. Read the results at 10 minutes once the coloured line(s) have appeared. Results read after 20 minutes are considered invalid.
Dengue IgG/IgM Rapid Test Dengue IgG/IgM Rapid Test

Principle

The Biopanda Dengue Rapid Test Cassette is a qualitative membrane-based immunoassay for the detection of Dengue antibodies in whole blood, serum, or plasma. This test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in IgG test line region. During testing, the specimen reacts with Dengue antigen-coated particles in the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in the IgG test line region. If the specimen contains IgG antibodies to Dengue, a coloured line will appear in IgG test line region. In the IgM component, anti-human IgM is coated in the IgM test line region. During testing, the specimen reacts with anti-human IgM. Dengue IgM antibodies, if present in the specimen, reacts with the anti-human IgM and the Dengue antigen-coated particles in the test cassette, and this complex is captured by the anti-human IgM, forming a coloured line in IgM test line region.

Therefore, if the specimen contains Dengue IgG antibodies, a coloured line will appear in IgG test line region. If the specimen contains Dengue IgM antibodies, a coloured line will appear in IgM test line region. If the specimen does not contain Dengue antibodies, no coloured line will appear in either of the test line regions, indicating a negative result. 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.

Performance Characteristics

  • Relative sensitivity: 95.7%
  • Relative specificity: >99.9%
  • Accuracy: 99.3%

Storage Conditions

+2 - 30 °C


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