Lyme IgG/IgM Rapid Test CE Marking


Product Number: RAPG-LYM-001

Pack size

20 tests

Product Description

The Biopanda Lyme IgG/IgM Rapid test qualitatively detects for the presence of IgG and IgM antibodies to Borrelia speciesin 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 diagnosis of Lyme Disease

Test Procedure

  1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible.
  2. Place the cassette on a clean and level surface.
For Serum or Plasma specimens:
  • To use a pipette: Transfer 5 μl of Serum/ Plasma to the specimen well (S), then add 3 drops of buffer (approximately 120 μl) to the buffer well (B).
  • To use a dropper: Hold the dropper vertically, draw the specimen up to the upper end of the nozzle as shown in illustration below (approximately 5 μl). Transfer the specimen to the specimen well (S), then add 3 drops of buffer (approximately 120 μl) to the buffer well (B), and start the timer.
For Whole Bloodspecimens:
  • To use a pipette: Transfer 10 μl of whole blood to the specimen well (S), then add 3 drops of buffer (approximately 120 μl) to the buffer well (B).
  • To use a dropper: Hold the dropper vertically, draw the specimen about 1 cm above the upper end of the nozzle and transfer 1 full drop (approx. 10 μl) of specimen to the sample well (S). Then add 3 drops of buffer (approximately 120 μl) to the buffer well (B), and start the timer.

3. Wait for the coloured line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.

Lyme test diagram

Principle

The Biopanda Lyme IgG/IgM Rapid Test is a qualitative membrane-based immunoassay for the detection of IgG and IgM antibodies to Borrelia in whole blood, serum or plasma specimens. 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 Borrelia antigen-coated particles in the test cassette. The mixture then migrates laterally 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 Borrelia a coloured line will appear in IgG test line region as a result of this. Similarly, anti-human IgM is coated in the IgM test line region and if specimen contains IgM antibodies to Borrelia, the conjugate-specimen complex reacts with anti-human IgM. A coloured line will appear in the IgM test line region as a result. Therefore, if the specimen contains anti-Borrelia IgG antibodies, a coloured line will appear in IgG test line region. If the specimen contains anti-Borrelia IgM antibodies, a coloured line will appear in IgM test line region. If the specimen does not contain anti-Borrelia 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

Test Sensitivity Specificity Accuracy
IgG 95.5% 98.9% 98.2%
IgM 94.4% 98.9% 98.1%

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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