Malaria HRP2/pLDH (P.fP.v) Antigen Rapid Test Kit (Lateral chromatography)

Intended Use
Malaria antigen detection kit is designed as a simple, rapid, qualitative and cost effective method for the simultaneous detection and differentiation of Plasmodium falciparum (P.f) and Plasmodium vivax (P.v) in human whole blood or fingertip whole blood. This device is intended to be used as a screening test and used for the auxiliary diagnosis of P. f and P.v infection.

Test Principle
The Malaria antigen test kit (Lateral chromatography) is based on the principle of microsphere double antibody sandwich method to rapid qualitative determination of P.f/ P.v antigen in human whole blood or fingertip whole blood. The microsphere is marked in anti-HRP-2 antibody (specific to P.f) on the T1 band and anti-PLDH antibody(specific to P.v) on the T2 band, and anti-mouse IgG polyclonal antibody is coated on quality control area (C). When the sample contains malaria HRP2 or pLDH antigen and the concentration is higher than the minimum detection limit, which are allowed to react with the colloidal microsphere coated with Mal-antibody to form antibody-antigen complex. The complex then moves laterally on the membrane and respectively binds to the antibody immobilized on the membrane producing a pink line on the test region, which indicates a positive result. The presence of the control line demonstrates the test has been performed correctly regardless the presence of P.f/ P.v antigen.