ADVANTAGE P.f MALARIA CARD

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INTENDED USE

ADVANTAGE P.f MALARIA CARD is a rapid, visual and sensitive immunoassay for the qualitative diagnosis of P.falciparum(P.f) specific Histidine-rich protein-(P.f. HRP-2) in human whole blood only.

SALIENT FEATURES

  • Rapid visual antigen based test for detecting infection with P.falciparum (HRP-2) malaria parasite in whole blood.
  • Excellent Sensitivity & Specificity as per WHO Malaria RDTs Evaluation.
  • Sensitivity of 50 -100 parasites per µl of blood.
  • See through Device for easy result interpretation.
  • Longer shelf life -24 months, storage at 4-30° C.
  • Results within 20 minutes
ADVANTAGE P.f MALARIA CARD is an immunoassay based on the "Sandwich principle" . Colloidal gold is conjugated to monoclonal anti- Pf specific HRP-2 antibody. The test uses monoclonal anti-Pf HRP-2 antibody (test line F) immobilized on a nitrocellulose strip. The test sample is added to the device. On addition of assay buffer, the red blood cells get lysed.If the sample contains P.falciparum the colloidal gold conjugate complexes the Pf specific HRP-2 in the lysed sample. This complex migrates through the nitrocellulose strip by capillary action. When the complex meets the line of the corresponding immobilized antibody, the complex is trapped forming a purplish pink band which confirms a reactive test result. Absence of a coloured band in the test region indicates a negative test result. To serve as a procedural control an additional line of anti-mouse antibody has been immobilized on the strip as control.
ORDERING INFORMATION
PRODUCT NAME PACK SIZE CATALOG NO.
ADVANTAGE P.f MALARIA CARD 25 Tests IR016025

EVALUATIONS
  • PERFORMANCE CHARACTERISTICS (INTERNAL EVALUATION) OF ADVANTAGE P.f MALARIA CARD
    Sample Total no of samples tested Advantage P.f MALARIA CARD Sensitivity Specificity
        Positive Negative % %
    Malaria Negative 500 1 499 - 99.80
    P.falciparum Positive 50 50 0 100 -
    P.vivax Positive 40 0 40 - 100

    PRECISION:Within-run and between-run precisions have been determined by testing 10 replicates of three specimens: a negative. a low positive and a strong positive. The negative, low positive and strong positive results were correctly identified 100 % of the time.

  • PERFORMANCE RESULT AS PER WHO PRODUCT TESTING FOR MALARIA RAPID DIAGNOSTIC TESTS(2008),PAGE 17 FOR ADVANTAGE P.f MALARIA CARD
      Sensitivity Specificity
    200 Parasites 97.47 % -----
    2000 Parasites 100 % -----
    Negative Samples ----- 100 %
    http://apps.who.int/tdr/svc/publications/tdr-research-publications/rdt-performance

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