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ADVANTAGE PAN MALARIA CARD

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INTENDED USE

ADVANTAGE PAN MALARIA CARD is a rapid, visual and sensitive immunoassay for the qualitative diagnosis of all four Plasmodium Species (P.falciparum/P.vivax/P.malariae/P.ovale) based on pLDH antigen in human whole blood only.

SALIENT FEATURES

  • Detects infection with Plasmodium species(P.falciparum/P.vivax/P.malariae/P.ovale)
  • Excellent Sensitivity & Specificity as per WHO Malaria RDTs Evaluation.
  • See through Device for easy result interpretation.
  • Longer shelf life -24 months, storage at 4-30° C.
  • Results within 20 minutes.
ADVANTAGE PAN MALARIA CARD is an immunoassay based on the “Sandwich principle”. The method uses monoclonal anti-pan specific pLDH(plasmodium lactate dehydrogenase) antibody conjugated to colloidal gold and another monoclonal anti-pan specific pLDH antibody immobilized on a nitrocellulose strip in a thin line. The test sample is added in the sample well ‘A’, followed by addition of Assay buffer in Buffer well ‘B’. If the sample contains P.falciparum/P.vivax/P.malariae/P.ovale, the colloidal gold conjugate complexes the Pan specific pLDH 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 colored band in the test region indicates a non-reactive 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 PAN MALARIA CARD 25 Tests IR013025

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

    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 COV (%) of negative, low positive and strong positive values were with in 10 % of the time.

  • PERFORMANCE RESULT AS PER WHO PRODUCT TESTING FOR MALARIA RAPID DIAGNOSTIC TESTS(2008),PAGE 17 FOR ADVANTAGE PAN MALARIA CARD
      Sensitivity Specificity
    200 Parasites 100 %* (P.v) -----
    2000 Parasites 100 %* -----
    Negative Samples ----- 98.21 %
    http://apps.who.int/tdr/svc/publications/tdr-research-publications/rdt-performance

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