One Step Malaria Rapid Test Kit (Cassette)

Intended use
The Malaria P.f. Rapid Test Device (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of circulating plasmodium falciparum in whole blood.

Test principle
The Malaria P.f. Rapid Test Device (Whole Blood) is a qualitative, membrane based immunoassay for the detection of P.f. antigen in whole blood. The membrane is pre-coated with P.f. antibody.During testing, the whole blood specimen reacts with the dye conjugate, which has been pre-coated in the test Device. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with P.f. antibody on the membrane on the test line. If the specimen contains P.f. antigen, a colored line will appear in the test region. The absence of the colored line in test region indicates that the specimen does not contain P.f. antigen. To serve as a procedure control, a colored line will always appear in the control region indicating that proper volume of specimen has been added and membrane wicking has occurred.

Test Procedure
Allow the test Device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

1. Testing: Place the test device on a clean and level surface. Transfer the specimen to the specimen well by a pipette or a dropper:
   (2.1) To use a Pipette: Transfer whole blood to the specimen tube, then add 3 full drops of buffer and start the timer.
   (2.2) To use a Disposable Specimen Dropper: Hold the dropper vertically, draw the specimen up to the Fill Line up to. Transfer the specimen to the specimen well, then add 3 full drops of buffer and start the timer.
2. Test Results: Wait for the colored line(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.