One-Step Malaria Pf/Pv Ab Rapid Test(Strip/Cassette/Uncut sheet)

Malaria Pf/Pv Ab Rapid Test(Whole Blood )

INTENDED USE
The Malaria Gold Rapid 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, and malariea (Pv.o.m) in 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 Gold Rapid Test must be confirmed with alternative testing method(s) and clinical findings.

SUMMARY AND EXPLANATION OF THE TEST
Malaria is a mosquito-borne, hemolytic, febrile illness that infects over 200 million people and kills more than 1 million people per year. It is caused by four species of Plasmodium: P. falciparum, P. vivax, P.ovale,and P. malariae. These plasmodia all infect and destroy human erythrocytes, producing chills, fever, anemia, and splenomegaly. P.falciparum causes more sever disease than the other plasmodial species and accounts for most malaria deaths. P. falciparum and P. vivax are the most common pathogens, however, there is considerable geographic variation in species distribution1.Traditionally, malaria is diagnosed by the demonstration of the organisms on Giemsa stained smears of peripheral blood, and the different species of plasmodium are distinguished by their appearance in infected erythrocytes1. The technique is capable of accurate and reliable diagnosis, but only when performed by skilled microscopists using defined protocols2, which presents major obstacles for the remote and poor areas of the world. The Malaria Gold Rapid Test is developed for solving these above obstacles. 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.

TEST PRINCIPLE
The Malaria Gold Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored
conjugate pad containing recombinant HRP-II and aldolase conjugated with colloid gold (Pf conjugates and Pan-malariaconjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing two test bands (T1 and T2 bands) and a control band (C band). The T1 band is pre-coated with recombinant HRP-II antigen for the detection of antibodies to Pf only, T2 band is pre-coated with aldolase for the detection of antibodies to Pan-malaria protozoa, and the C band is precoated with goat anti rabbit IgG.