Advantage MAL Card

Intended Use

Advantage MAL Card is a visual, rapid and sensitive immunoassay for the qualitative diagnosis of P.falciparum and other Plasmodium Species (P.vivax/ P.malariae/ P.ovale/ P.falciparum) based on pLDH antigen in human whole blood.

Salient Features

• Infection free- See through Device based on pLDH antigen Malaria parasite in whole blood
• Excellent Sensitivity & Specificity as per WHO Malaria RDTs Evaluation.
• Longer shelf life of 30 months at 4-30° C.
• Easy to interpret Colour Bands
• Results within 20 minutes.

Principle

Advantage MAL Card is an immunoassay based on the “Sandwich principle” .The conjugate contains colloidal gold conjugated to monoclonal anti-pan specific pLDH (plasmodium lactate dehydrogenase) antibody. The test uses monoclonal anti-Pf pLDH antibody (test line F) & monoclonal anti-Pan specific pLDH antibody (test line P) 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 or P.vivax/P.malariae/P.ovale, the colloidal gold conjugate complexes the P.f specific pLDH/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 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

Evaluations

(i) WHO Evaluation:

The Advantage MAL Card test kit has been evaluated by WHO, Geneva using a panel of wild & cultured malaria positive samples and the results obtained are as follows :

*Reference : Malaria Rapid Diagnostic Test Performance: Results of WHO product testing of malaria RDTs: Round 5 (2013), Page:38.

Note : The above information is provided for the scientific community, It is not for commercial or promotional purpose

http://apps.who.int/tdr/svc/publications/tdr-research-publications/rdt-performance

(ii) In-house Evaluation
Analytical Sensitivity: The test can detect parasitemia levels of >100 parasites per µl of blood for P. falciparum (pLDH) and >200 parasites per µl of blood for P. vivax (pLDH) . The Advantage MAL CARD has been evaluated in-house with malaria positive and negative clinical whole blood samples and compared with microscopic examination. The evaluation also included cross-reacting samples; Dengue, Rheumatoid factor, Leptospira, HIV, HCV, HBV, M. tuberculosis, Syphilis, Brucella, Scrub typhus positive samples. The results obtained are as follows:

Precision : Within-run and between-run precisions have been determined by testing 10 replicates of 8 specimens: four negative and four positive; two weak and two moderate positive. The C.V (%) of negative, moderate positive and weak positive samples were within 10% of the time.