Advantage Malaria Card

Intended Use

Advantage Malaria Card is a visual, rapid and sensitive immunoassay for the qualitative differential detection of P.falciparum (HRP-2) and P.vivax (pLDH) malaria antigen in human blood only.

Salient Features

• Rapid, visual antigen based test for detecting infection with P.falciparum (HRP-2) & P.vivax (pLDH) malaria parasite in whole blood.
• Excellent Sensitivity & Specificity.
• See through Device for easy result interpretation.
• Longer shelf life of 30 months at 4-30° C.
• Easy to interpret colour bands
• Results within 20 minutes.

Principle

Advantage Malaria Card is an immunoassay based on the “Sandwich principle”. Colloidal gold is conjugated to P.f. specific monoclonal anti-HRP-2 antibody and monoclonal anti-pan specific pLDH (plasmodium lactate dehydrogenase) antibody. The test uses monoclonal anti-Pf HRP-2 antibody (test line F) & monoclonal anti-P.v specific pLDH antibody (test line V) 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 or both, the colloidal gold conjugate complexes the HRP-2 / P.vivax 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

Performance Characteristics Of Advantage Malaria Card

(i) In-house Evaluation
Analytical Sensitivity: The test can detect parasitemia levels of >100 parasites per µl of blood for P. falciparum (HRP-2) and >200 parasites per µl of blood for P. vivax (pLDH) .
The Advantage Malaria 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 seven specimens : one negative, three P.f (weak positive) and three P.v (one weak and two medium) positive samples. The C.V (%) of negative, weak positive and strong positive samples were within 10% of the time.

(ii) Performance Evaluation:

All India Institute of Medical Sciences New Delhi.

AIIMS-New Delhi-As per evaluation at AIIMS with 200 fresh blood samples from random donors with known positive samples indicated 100 % sensitivity for both P.falciparum & P. vivax and 100 % specificity.