INTENDED USE:

The Malaria Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of antibodies including IgG, IgM and IgA to Plasmodium falciparum (Pf) and vivax, ovale, andmalariea (Pv.o.m) in human serum, plasma or whole blood. This device is intended to be used as a screening test and as an aid in the diagnosis of infection with Plasmodium. Any reactive specimen with the Malaria  Test must be confirmed with alternative testing method(s) and clinical findings.

 

SUMMARY:

It detects the antibodies generated in serum or plasma in response to the infection of plasmodium. Utilizing the Pf. specific antigen (HRP-II) and pan-malaria antigen (aldolase),the test enables simultaneous detection and differentiation of the infection of P.falciparum and or P. vivax, ovale, and malariae3-5, by untrained or minimally skilled personnel, without laboratory equipment. 

 

Clinical Performance For Pf/Pv Ab Test

Relative Sensitivity: 92% , Relative Specificity: 98.5%, Overall Agreement: 98.7%

 

PROCEDURE:

Step 1:Bring the specimen and test components to room temperature if refrigerated or frozen. Mix the specimen well prior to assay once thawed.

Step 2: When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface.

Step 3: Be sure to label the device with specimen’s ID number.

Step 4: For whole blood test

      Apply 1 drop of whole blood (about 30-45 ul) into the sample   well.Then add 1 drop of Sample Diluent.

            For serum or plasma test

Fill the pipette dropper with the specimen.

Holding the dropper vertically, dispense 1 drop (about 30-45 μl) of specimen into the sample well making sure that there are no air bubbles.

Then add 1 drop of Sample Diluent.

Step 5: Set up the timer.

Step 6: Results can be read in 15 minutes. Positive results can be visible in as short as 1 minute.