Item No.: DPC-9022
Item Name:Home Malaria Rapid Test Kit

Intended use: The One Step Malaria(p.f) Test is a two site sandwich immunoassay utilizing whole blood for the detection of Malaria P.falciparum specific histidine rich protein-2(Pf HRP-2), The test can also be used for specific detection and differentiation of P. falciparum.

Summary: Malaria is a serious paraitc 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. In humans, the parasites migrate to the liver where they mature and release another form, the merozoites.
The One Step Malaria pf (HRP-II) Test Device is a simple, visual qualitative test that detects antibodies in human whole blood. The test is based on immunochromatography and can give a result within 15 minutes.

PRINCIPLE OF THE PROCEDURE:
The assay starts with a diluent prepared sample applied to the sample well. The Malaria pf -colloidal gold conjugate embedded in the sample pad reacts with the Malaria pf antigen present in whole blood sample forming conjugate-Malaria pf antigen complex. As the mixture is allowed to migrate along the test strip, the conjugate-Malaria pf antigen complex is captured by Malaria HRP-II antibody immobilized on the membrane forming a colored test band in the test region. A negative sample does not produce a test band due to the absence of conjugate-Malaria pf antigen complex. The antibodies used in the conjugate test are recombinant proteins that correspond to highly immunoreactive regions Malaria pf(HRP-II). A colored control band in the control region appears at the end of test procedure regardless of test result. The control band indicates that the colloidal gold conjugate is functional.

REAGENTS AND MATERIALS SUPPLIED:
• Test card / test strip individually foil pouched with a desiccant
• Plastic dropper
• Alcohol Prep Pad
• Package insert
• Sterile Band Aid
• Blood lancet
• Sample diluent

STORAGE AND STABILITY: The kit must be stored at 2 - 30°C.

WARNINGS AND PRECAUTIONS:
1.  ALL positive results must be confirmed by an alternative method.
2.  Treat all specimens as though potentially infectious.
3.  Wear gloves and protective clothing when handling specimens.
4.  Standard safety precautions in the handling of bioharzardous material.
5.  Should be observed in specimen handling. Dispose of used lancets.
6.  Capillary tubes and cassettes in designated biohazard disposal containers.
7.  Devices used for testing should be autoclaved before disposal.
8.  Do not use kit materials beyond their expiration dates.
9.  Do not interchange reagents from different lot of kit.