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HEV Rapid Test CE Marking


Product Number: RAPG-HEV-001

Pack size

20 tests

Product Description

The Biopanda HEV Rapid Test detects and differentiates between IgG and IgM antibodies to Hepatitis E virus (HEV) in human serum or plasma samples.

Test Attributes

  • Serum or plasma samples may be used for testing
  • Results available in only 20 minutes
  • Easy to use
  • Results can be read visually
  • No need for an analyser
  • Cost effective method for assisting in the diagnosis of HEV infections

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. Holding the pipette vertically, transfer 1 drop (approx. 25 μl) of the serum or plasma sample into the specimen well. Immediately add 1 drops of buffer (approx. 40 μl) to the specimen well. Avoid trapping air bubbles.
  4. Read results after 20 minutes when coloured lines have appeared in the test region.
  5. Results read after 20 minutes are considered invalid. Dispose of the cassette safely after testing.
HEV Rapid Test

Principle

The HEV Rapid Test Cassette is a qualitative membrane-based immunoassay for the detection of HEV antibodies in 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 the IgG test line region. During testing, the specimen reacts with HEV antigen-coated particles in the test cassette. The mixture then migrates upward along 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 HEV, a coloured line will appear in the 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. HEV IgM antibodies, if present in the specimen, reacts with the anti-human IgM and the HEV antigen-coated particles in the test cassette, and this complex is captured by the anti-human IgM, forming a coloured line in the IgM test line region. Therefore, if the specimen contains HEV IgG antibodies, a coloured line will appear in the IgG test line region. If the specimen contains HEV IgM antibodies, a coloured line will appear in the IgM test line region. If the specimen does not contain HEV 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


IgG
  • Relative sensitivity: 90.0%
  • Relative specificity: 98.7%
  • Accuracy: 97.6%
IgM
  • Relative sensitivity: 93.3%
  • Relative specificity: 98.6%
  • Accuracy: 97.9%

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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