Tri-line Malaria pf/pan antibody Home Testing kits, personal use,individual package, blood test

Product Name:

Tri-line Malaria pf/pan antibody Home Testing kits


INTENDED USE: Malaria P.f & Pan Ab test is an immunochromatographic (rapid) test for the qualitative detection of antibodies of all isotypes (IgG, IgM, IgA) specific to Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, Plasmodium malariae simultaneously in human serum or plasma or whole blood.

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.There 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/pan Detection Test Device(Whole Blood) contains a membrane strip,which is pre-coated with two monoclonal antibodies as two separate lines across a test strip.One monoclonal antibody(test line 1)is specific to the p.falciparum histidine rich protein-2(Pf HRP-2) and another monoclonal antibody(test line 2) is pan specific to the lactate dehydrogenase of Plasmodium species(P.falciparum,vivax,malariae,ovale).Conjugate pad is dispensed with monoclonal antibodies conjugated to colloidal gold,which are specific to P.falcparum histidine rich protein-2(Pf HRP-2)and pan specific to the lactate dehydrogenase of Plasmodium species.

SPECIMEN COLLECTION

Collect whole blood into a collection tube (containing EDTA,citrate or heparin) by venipuncture.

If specimens are not immediately tested,they should be refrigerated at 2~8.For storage periods greater than three days,freezing is recommended.They should be brought to room temperature prior to use. Using the specimen after long-term storage of more than three days can cause non-specific reaction.

When stored at 2~8℃,the whole blood sample should be used within three days.

INTERPRETATION OF RESULTS



1. NEGATIVE RESULT: If only the C band is present, the absence of any burgundy color in the both T bands (T1 and T2) indicates that no anti-plasmodium antibodies are detected. The result is negative.

2. POSITIVE RESULT:

2.1 In addition to the presence of C band, if only T1 band or both T1 and T2 band are developed, the test indicates for the presence of antibodies to Pf in the specimen. The result is Pf positive.

2.2 In addition to the presence of C band, if only T2 band is developed, the test indicates for the presence of antibodies to Pf, P. vivax, oval, and or malariae in the specimen. The result is positive.

3. INVALID: If no C band is developed, the assay is invalid regardless of any burgundy color in the T bands as indicated below. Repeat the assay with a new device.In addition to the presence of C band, if only T2 band is developed, the test indicates for the presence of antibodies to Pf, P. vivax, oval, and or malariae in the specimen. The result is positive.

Performance Study