THE RAPID 1-2-3® HEMA CASSETTE MALARIA PF

INTENDED USE

The RAPID 1-2-3® HEMA CASSETTE MALARIA PF (the TEST) is a rapid, qualitative, two site sandwich immunoassay for the determination of P. falciparum specific histidine rich protein - 2 (Pf. HRP-2) in whole blood samples. It is for Professional In-Vitro Diagnostic use only. The Test is not automated and does not require additional instrumentation.

BACKGROUND

Four species of the Plasmodium parasites are responsible for malaria infections in humans, P. falciparum, P. vivax, P. ovale and P. malariae. Of these, P. falciparum is the most prevalent and severe species that is responsible for most of the morbidity and mortality worldwide. Early detection of P. falciparum malaria is of paramount importance due to incidence of cerebral malaria and drug resistance associated with it. Pf. HRP-2 is a water soluble protein that is released from parasite containing erythrocytes of infected individuals and is specific to the P. falciparum species.

The RAPID 1-2-3® HEMA CASSETTE MALARIA PF detects the presence of Pf. HRP-2 in whole blood specimen and is a sensitive and specific test for the detection of P. falciparum malaria.

PRINCIPLES OF THE TEST

The RAPID 1-2-3® HEMA CASSETTE MALARIA PF is a rapid test for the detection of P. falciparum malaria that utilizes the principle of immunochromatography. As the test sample flows through the membrane assembly of the device after addition of the buffer, the colored monoclonal anti Pf. HRP-2 (IgG) colloidal gold conjugate antisera complexes the Pf. HRP-2 in the lysed sample. This complex moves further on the membrane to the test region where it is immobilized by the monoclonal anti Pf. HRP-2 (IgM) antisera coated on the membrane leading to formation of a pink-purple colored band which confirms a positive test result. Absence of this colored band in the test region indicates a negative test result. The remaining conjugate and unbound complex if any, move further on the membrane and are subsequently immobilized by anti rabbit antibodies coated on the membrane at the control region, forming a pink-purple band. This control band serves to validate the test performance.

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