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

INTENDED USE

The RAPID 1-2-3® HEMA CASSETTE MALARIA PF/PAN (the Test) is a rapid lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of HRP-II (Histidine-rich protein II) specific to Plasmodium falciparum and pLDH (Plasmodium lactate dehydrogenase) specific to Plasmodium species (Pan) in human blood specimen as an aid in the diagnosis of Malaria infection and for the follow up of antimalarial therapy. It is for In-Vitro Diagnostic use only.

BACKGROUND

Malaria is a serious, sometimes fatal, parasitic disease characterized by fever, chills, and anemia and is caused by a parasite that is transmitted from one human to another by the bite of infected Anopheles mosquitoes. There are four kinds of malaria that can infect humans: Plasmodium falciparum, P. vivax, P. ovale, and P. malariae. Of these, P. falciparum and P.vivax are the most prevalent. Early detection of malaria is of utmost importance due to incidence of cerebral malaria and drug resistance associated with falciparum malaria and due to the morbidity associated with the other malarial forms. As the course of treatment is of utmost importance for better patient management and speedy recovery.
In humans, the parasites (called sporozoites) migrate to the liver where they mature and release another form, the merozoites. The disease now occurs in more than 90 countries worldwide, and it is estimated that there are over 500 million clinical cases and 2.7 million malaria-caused deaths per year. At the present, malaria is diagnosed by looking for the parasites in a drop of blood. Blood will be put onto a microscope slide and stained so that the parasites will be visible under a microscope.

PRINCIPLES OF THE TEST

The RAPID 1-2-3® HEMA CASSETTE MALARIA PF/PAN utilizes the principle of immunochromatography. It contains a membrane strip, which is precoated with mouse monoclonal antibodies specific to HRP-II of P. falciparum on test line Pf(T2) region and with mouse monoclonal antibodies specific to lactate dehydrogenase of Plasmodium species (P. falciparum, P. vivax, P. malariae and P. ovale) on test line Pan (T1) region respectively. A conjugate pad is dispensed with a mixture of mouse monoclonal antibodies specific to HRP-II of Pf and mouse monoclonal antibodies specific to pLDH of pan-colloidal gold.

During the running of the RAPID 1-2-3® HEMA CASSETTE MALARIA PF/PAN, blood specimen is added into the sample well (S) of the test cassette. A lysis diluent is added to the diluent well (B). The diluent contains a detergent that lyses the red blood cells and releases various antigens, which migrate by capillary action across the strip held in the cassette. Pan-LDH if present in the specimen will bind to the Pan-LDH-gold conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-Pan-LDH antibody, forming a reddish colored Pan (T1) band, indicating a Pan positive test result.

Alternatively, if pHRP-II is present in the specimen it will bind to the pHRP-II-gold conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-pHRP-II antibodies, forming a reddish colored Pf (T2) band, indicating a Pf positive test result. Absence of any “T” lines suggests a negative result. The test contains an internal control (“C” line) which should exhibit a reddish colored band of the immunocomplex of goat anti- mouse IgG / mouse IgG (anti-Pan-LDH and anti-pHRP-II)-gold conjugates regardless of the color development on any of the T lines. Otherwise, the test result is invalid and the specimen must be retested with another device.

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