Advantage Malaria PAN+Pf Card

Intended Use

Advantage Malaria PAN+Pf Card is a rapid, visual and sensitive immunoassay for the qualitative diagnosis of infection with P.falciparum and other Plasmodium species (P.falciparum/P.vivax/P.malariae/P.ovale) in human whole blood only.

Salient Features

• Detects P.f. (HRP-2) and PAN(pLDH)
• Individually pouched Single tests- Practical & Safe
• Infection free- See through Device
• Easy to perform test
• Easy to interpret Colour bands
• Results within 20 minutes
• Sensitivity of 100% & Specificity of 99.80%
• Longer shelf life -30 months, storage at 4-30° C

Principle

Advantage Malaria PAN+Pf Card is an immunoassay based on the “Sandwich” principle. The conjugate contains colloidal gold conjugated to Pf specific monoclonal anti- HRP-2 antibody and monoclonal anti-pan specific pLDH antibody. The test uses monoclonal anti-Pf HRP-2 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 Pf specific HRP-2/ 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 Malaria PAN+Pf Card test kit has been evaluated by WHO, Geneva using a panel of wild & cultured malaria positive sample 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

(ii) In-house Evaluation
Analytical Sensitivity: The test can detect parasitemia levels of >50 parasites per µl of blood for P. falciparum (HRP-2), > 100 parasites per µl of blood for P. falciparum (pLDH) & P. vivax . The Advantage Malaria PAN+Pf 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 six specimens : two negative, two weak positive and two moderate positive. The C.V (%) of negative, weak positive and moderate positive samples were within 10% of the time.