Advantage P.f. Malaria Card

Test Kit Type: Rapid Test Kit
Based On: Sandwich principle
Result Time: Within 20 Minutes
Device: See through Device

Intended Use

Advantage P.f. Malaria Card is a rapid, visual and sensitive immunoassay for the qualitative diagnosis of P.falciparum(P.f) specific Histidine-rich protein-(P.f. HRP-2) in human whole blood only.

Salient Features

Rapid visual antigen based test for detecting infection with P.falciparum (HRP-2) malaria parasite in whole blood.
Excellent Sensitivity & Specificity as per WHO Malaria RDTs Evaluation.
Sensitivity of 50 -100 parasites per µl of blood.
See through Device for easy result interpretation.
Longer shelf life -30 months, storage at 4-30° C.
Results within 20 minutes

Principle

Advantage P.f. Malaria Card is an immunoassay based on the “Sandwich principle” . Colloidal gold is conjugated to monoclonal anti- Pf specific HRP-2 antibody. The test uses monoclonal anti-Pf HRP-2 antibody (test line F) 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 the colloidal gold conjugate complexes the Pf specific HRP-2 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

Product Name	Pack Size	Catalog No.
Advantage P.f. Malaria Card	25 Tests	IR016025

Evaluations

(i) WHO Evaluation:

The Advantage P.f. 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	89.0%	–
2000 Parasites	99.0%	–
Negative Samples	–	100 %*

*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
The test can detect parasitemia levels of >100 parasites per µl of blood for P.f (HRP-2).
The Advantage Pf Malaria Card kit 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, HIV, HCV, HBV, ASO and Syphilis positive samples. The results obtained are as follows:

Sample	No. Of Samples tested	Advantage P.f. Malaria Card		Sensitivity	Specificity
Sample	No. Of Samples tested	Positive	Negative	Sensitivity	Specificity
Malaria Negative	700	1	700	–	100
Cross-reacting sample	14	0	14	–	100
P.falciparum Positive	57	57	0	100	–
P.vivax Positive	3	0	3	–	100

Precision : Within-run and between-run precisions have been determined by testing 10 replicates of 6 specimens : 4 negative and 6 positive samples (1 strong, 1 medium and 4 weak ). The CV% of negative and all positive samples were within 10% of the time.