For the rapid qualitative determination of Malaria P.falciparum specific histidine rich protein-2(Pf HRP-2)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 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(HRPⅡ) Antigen Detection Test Device(Whole Blood) contains a membrane strip,which is pre-coated with pf monoclonal antibodies, antibody(test line )is specific to the p.falciparum histidine rich protein-2(Pf HRP-2).Conjugate pad is dispensed with monoclonal antibodies conjugated to colloidal gold ,which are specific to P.falcparum histidine rich protein-2(Pf HRP-2).
Instructions for Use
5ul sample loop
Materials 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℃.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.
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 pink colored bands will 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 and/or the test reagent has been deteriorated.
1.For professional in vitro diagnostic use only,Do not use after expiration date.
2.Do not eat,drink or smoke in the arer where the specimens or kits are handled.
3.Handle all specimens as if they contain infectious agents.Observe established precoutions against mocrobiological hazards throughout testing and follow the standard procedures for proper disposal of specimens.
4.Wear protective clothing such as laboratory coats,disposable gloves and eye protection when specimens are being tested.
5.Humidity and temperature can adversely affect results.
Storage and Stability:
The kit can be stored at room temperature or refrigerated(2-30℃).
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.