INTENDED USE
David One Step Malaria( P.f. /P.v Antigen) Rapid Test is a rapid, one-step, visual test for the qualitative detection of two kinds of circulating plasmodium falciparum(P. falciparum (P.f.) and P. vivax (P.v.)) in human blood Specimen.
PRINCIPLE
The detection system for malaria is based on the detection of P.falciparum specific histidine rich protein-2 (Pf. HRP-2) and P.vivax specific pLDH.
David One Step Malaria( P.f. /P.v Antigen) Rapid Test utilizes the principle of two antibody sandwich lateral flow chromatographic immunoassay. The test Strip contains anti-HRP-II of Plasmodium falciparum antibodies conjugated gold and anti-Plasmodium falciparum P.vivaxLDH antibodies conjugated gold and anti-HRP-II antibodies and anti-pLDH antibodies coated on the membrane
The membrane is precoated with anti-HRP-II antibodies and anti-pLDH antibodies. During testing, the whole blood specimen reacts with the dye conjugate, which has been pre-coated on the test strip. The mixture then migrates upward on the membrane by capillary action, reacts with anti-Histidine Rich Protein II (HRP-II) antibodies on the membrane on P.f. Test Line region and with antipLDH antibodies on the membrane on P.v. Line region. If the specimen contains HRP-II or Plasmodium-specific P. vivaxLDH or both, a colored line will appear in P.f. line region or P.v. line region or two colored lines will appear in P.f. line region and P.v. line region. The absence of the colored lines in P.f. line region or P.v. line region indicates that the specimen does not contain HRP-II and/or Plasmodium-specific P. vivaxLDH. To serve as a procedure control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.
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