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HBsAb Rapid Test CE Marking


Product Number: RAPG-HBsAb-001

Pack size

20 tests

Product Description

The Biopanda HBsAb Rapid test qualitatively detects for the presence of Hepatitis B surface antibody in human serum or plasma samples. This test applies lateral flow immuno-chromatography and is for professional in vitro diagnostic use.

Test Attributes

  • Serum or plasma samples may be used for testing
  • Results available in only 15 minutes
  • Easy to use
  • Results can be read visually
  • No need for an analyser
  • Cost effective method for assisting in the detection of Hepatitis B surface antibodies

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. Using a dropper provided transfer 3 drops of the serum or plasma (approx. 75 μl) to the sample well on the cassette. Avoid trapping air bubbles.
  4. Read results at 15 minutes.
  5. Results read after 20 minutes are considered invalid. Dispose of the cassette safely after testing.
HBsAb Rapid Test

Principle

The Biopanda HBsAb Rapid Test is a qualitative, lateral flow immunoassay for the detection of HBsAb in serum or plasma. The membrane is pre-coated with HBsAg on the test line region of the strip. During testing, the serum or plasma specimen reacts with the particle coated with HBsAg. The mixture migrates upward on the membrane chromatographically, by capillary action, to react with HBsAg on the membrane and generates a coloured line. The presence of this coloured line in the test region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a coloured line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

Performance Characteristics

  • Relative sensitivity: >99.9%
  • Relative specificity: 99.4%
  • Accuracy: 99.6%

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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