Intended use For the rapid qualitative determination of Malaria P.falciparum specifichistidine rich protein-2(PfHRP-2)and malaria P.vivax specific lactate dehydrogenase (pLDH)in human blood as an aid in the diagnosis of Malaria infection. Summary Malaria is a seriousparaitc 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 caninfect 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(HRP2) / pv(pLDH) 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 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 toP.falcparum histidline rich protein-2 (Pf HRP-2) and pan specific to the lactate dehydrogenase of Plasmodium species. Materials Materials Provided Test Device Assay Buffer Micropipette Instructions for Use Materilas lot Provided Calibrated pipette Lancet Timer 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 thanthree days can cause non-specificreaction. When stored at 2-8 ºC,the whole bloodsample should be used within threedays. 1. Clean the fingertip with an alcoholswab. 2. Squeeze the end of the fingertip andpierce with a sterile needle provided. 3. Wipe away the first drop of blood with sterile gauze or cotton. 4.Take a specimen micropipetteprovided, use the gracile side at the end of the micropipette to touch the finger prick site and take quantitative specimen. Reference as the below, Directions for Use 1.Use sample loop or pipette to add 5yl of whole blood into sample well(A). 2. Add 2 drops(60yl) of assay bufferinto well(B). 3.Read the test result within 20minutes. Interpretation of resultsNegative: Only one pink / purplebandappearsonthecontrol (C) region. No apparent band on the test region (Pv, Pf). Positive: P. falciparum malaria In addition to a pink /purple colored control (C)band, a pink / purplecolored band appear at the (P.f) region respectively. The result is P.f positive. P.vivax malaria: In additional to a pink / purple colored control(C)band, one pink / purple band appears at the (P.v) region. P.vivax malaria and P.falciparum malaria: In additional to a pink / purple colored control(C) band, one pink / purple band appears at the (P.v) region,the other pink / purple coloredband appear at the (P.f) region respectively. The result is P.f positive and P.v positive, Invalid: The test is invalid if no bands appear or the control line(C) doesn'tappear. If this occurs, the test should be repeated using a new one. Precautions 1. For professional in vitro diagnostic use only, Do not use after expiration date. 2. Read the instructions carefully before performing the test. 3. The test device must remain in the sealed pouch until use. Do not use if the pouch or device are damaged or if any lines are visible on the device before contact with the specimen. Do not freeze. 4. Do not eat, drink or smoke in the area where the specimens or kits are handled. 5. Handle all specimens as potentially infectious. 6. Follow standard bio-safety guidelines for handling and disposal of potentially infective material. 7.Wear protective clothing such as laboratory coats, disposable gloves and eyeprotection when specimens are being tested.
8.Humidity and temperature can adversely affect results.
Storage and Stability 1.The device can be stored at room temperature(2-30ºC). 2. The test device is stable through the expiration dateprinted on the sealed pouch. 3. The test device must remain in the sealed pouch untiluse. Do not freeze, Do not uses beyond the expirationdate.
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