Malaria P.f Ag Rapid Test

One Step Malaria Whole Blood Test Cassette is designed as a simple, rapid,qualitative and cost effective method for testing, in vitro, the presence of Plasmodium falciparum malaria in blood. The test is an antigen capture assay detecting presence of a specific soluble protein, histidine-rich protein II (Pf HRP-II), which is present in and released from infected red blood cells. The assay is intended for use with whole blood and does not require Additional instruments.

For in vitro diagnostic use only. For healthcare professional use only.

SUMMARY

Malaria remains one of the most serious tropical diseases in many parts of the world. It is rampant in most areas of the tropics. Malaria is caused by a parasite that is transmitted from one person to person by the bite of infected Anopheles mosquitoes. There are four kinds of malaria that can infect humans: P. falciparum, P.vivax, P. malariae, and P.ovale. It is transmitted by the bite of the infected Anopheles mosquito. Malaria also has been reported from blood transfusions or congenitally from mother to child. It is estimated to affect more than 500 million people causing between one and three million deaths every year. Though, to a large extent, it has been eradicated from large parts of North America and Europe,

PRINCIPLE

The One Step Malaria Whole Blood Test is a rapid test for the visual detection of Malaria antigen in whole blood. This Malaria test adopts immunochromatographic method.

When lytic blood specimen is added to the sample well, the specimen is absorbed into the device by capillary action, mixes with the antibody-dye conjugate, and flows across the pre-coated membrane.

When the Malaria antigen levels are at or above the target cutoff, Malaria antigens in the specimen bind to the antibody-dye conjugate and are captured by monoclonal antibody immobilized in the test region (T) of the device. This produces a colored Test band and indicates a positive result.

When the Malaria antigen levels are zero or below the target cut off (the detection sensitivity of the test). There is not a visible colored band in the test region (T) of the device. This indicates a negative result.

To serve as a procedure control, a colored line will appear at the control region (C), if the test has been performed properly.