Advantage PAN Malaria Card

Test Kit Type: Rapid Test Kit
Sensitivity & Specificity: Excellent as per WHO Malaria RDTs Evaluation.
Device: See through Device

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 -30 months, storage at 4-30° C.
Results within 20 minutes.

Principle

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	50 Tests	IR013050

Evaluations

(i) WHO Evaluation:

The Advantage PAN Malaria 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 :

	Panel Detection Score*	Specificity*
200 Parasites	77.0% (P.f) and (P.v)	–
2000 Parasites	98.0% (P.f) and 100.0% (P.v)	–
Negative Samples	–	96.6 %*

*Reference : Malaria Rapid Diagnostic Test Performance: Results of WHO product testing of malaria RDTs: Round 5 (2013), Page:39

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 >100 parasites per µl of blood for P. falciparum (pLDH) and P. vivax (pLDH) The Advantage PAN 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:

Sample	No. Of Samples tested	Advantage PAN Malaria Card		Sensitivity	Specificity
Sample	No. Of Samples tested	Positive	Negative	Sensitivity	Specificity
Malaria Negative	2010	1	2009	–	99.95
Cross-reacting sample	59	0	59	–	100
P.falciparum Positive	58	58	0	100	–
P.vivax Positive	105	105	0	–	100

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.