One Step Malaria pf(HRPⅡ)/PANLDH Antigen Detection
Test Device(Whole Blood)
For the rapid qualitative determination of Malaria P.falciparum specific histidine rich protein-2(Pf HRP-2)and malaria PANLDH specific lactate in human blood as an aid in the diagnosis of Malaria infection.
Malaria is a serious 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 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(HRPⅡ)/PANLDH Antigen 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 specific to the lactate dehydrogenase of Plasmodium species(P.falciparum,vivax,malariae,ovale).Conjugate pad is pre-coated 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.
5μl sample loop
Instructions for Use
Materilas not Provided
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℃. Freezing is recommended if the storage periods are more than 3 days.They should be brought to room temperature before testing. 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.
Directions for Use:
1.Add 5μl of whole blood into sample well(A),the small well.
2.Add 2-3 drops of assay buffer into developer well(B).
3.Read the test result in 20 min.
Interpretation of Results:
Positive: In addition to a pink colored control (C) band,one or two distinct pink colored bands will also appear in the test (T) region. Please consult your physician to perform a much more detailed exam.
Negative: Only one colored band appears on the control (C) region. No apparent band on the test (T) region.
Invalid: A total absence of color in both regions is an indication of procedure error.
For professional in vitro diagnostic use only.Do not use after expiration date.
Do not eat,drink or smoke in the area where the specimens or kits are handled.
Handle all specimens as if they contain infectious agents.Observe established precautions against microbiological hazards throughout testing and follow the standard procedures for proper disposal of specimens.
Wear protective clothing such as laboratory coats,disposable gloves and eye protection when specimens are being tested.
Humidity and temperature can adversely affect results.
Storage and Stability:
The kit can be stored at room temperature up to 30℃ or refrigerated.
The test device is stable through the expiration date printed on the sealed pouch.
The test device must remain in the sealed pouch until use.Do not freeze.Do not use beyond the expiration date.