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Malaria P.f./P.v. Rapid Test CE Marking


Product Number (Cassette): RAPG-MLR-004

Pack size

10 or 20 tests

Product Description

The Biopanda One Step Rapid Test detects and differentiates between Plasmodium falciparum (pf) and Plasmodium vivax (pv) in human blood samples. This test applies lateral flow immuno-chromatography and is a tool to assist in the diagnosis of malaria.

Test Attributes

  • Whole blood 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 malarial infections
  • Results increase the effective administration of anti-malarial drugs

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. Use the test as soon as possible or within one hour of opening.
  3. Transfer the whole blood specimen to the blood collection tube using a pipette or dropper.
    1. Pipette use: Transfer 5 µl of whole blood to the specimen well of the cassette, then add 3 drops of buffer (180 µl) and start the timer.
    2. Dropper use: Hold the dropper provided vertically and draw the blood specimen (5 µl) to the fill line (see illustration). Transfer the specimen to the specimen well on the cassette, then add 3 drops of buffer (180 µl) 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.
Malaria pf/pan Rapid Test Malaria pf/pan Rapid Test

Principle

The Biopanda Malaria P.f. /P.v. Rapid Test Cassette is a qualitative, membrane based immunoassay for the detection of P.f. and P.v. antigens in whole blood. The membrane is pre-coated with anti-HRP-II antibodies and anti-pLDH antibodies. During testing, the whole blood specimen reacts with the dye conjugate, which has been pre-coated on the test cassette. The mixture then migrates upward on the membrane by capillary action, reacts with anti-Histidine-Rich Protein II (HRP-II) antibodies on the membrane on P.f. Test Line region and with anti-pLDH antibodies on the membrane on P.v. Line region. If the specimen contains HRP-II or Plasmodium-specific P. vivaxLDH or both, a coloured line will appear in P.f. line region or P.v. line region or two coloured lines will appear in P.f. line region and P.v. line region. The absence of the coloured lines in P.f. line region or P.v. line region indicates that the specimen does not contain HRP-II and/or Plasmodium-specific P. vivaxLDH. To serve as a procedure 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 p.f. antigens: 99.9%
  • Relative sensitivity p.v. antigens: 98.2%
  • Relative specificity: 99.9%
  • Accuracy: 99.8%

Storage Conditions

+2 - 30 °C




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