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Tri - Line Home Medical Test Kits 95% Accuracy Detecting Malaria PF/PV Antigen

Categories Home Testing Kits
Brand Name: New Life
Certification: ISO13485,CE
Place of Origin: China
MOQ: 5000pcs
Price: USD0.4-USD1
Payment Terms: T/T, Western Union, MoneyGram
Supply Ability: 500000pcs/month
Delivery Time: 20-30days
Packaging Details: 1pc/pouch, 25pcs/box
Category: Tropical disease
Format: Strip/cassette
Specimen: Whole Blood/Serum/Plasma
Testing time: 5-15 minutes
Shelf Life: 24 Months
Application: Malaria pf/pv
Accuracy: 95.63%
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    Tri - Line Home Medical Test Kits 95% Accuracy Detecting Malaria PF/PV Antigen

    Tri-line Malaria pf/pv antigen Home Testing kits, personal use, 4mm cassette full kit, remote area use


    Product Name: Malaria P.f & P.v Home Testing kits



    INTENDED USE: The One Step Malaria (p.f/p.v) Cassette Test is a two site sandwich immunoassay utilizing whole blood for the detection of P. falciparum specific histidine rich protein-2 (Pf. HRP-2) and P. vivax specific pLDH. The test can also be used for specific detection and differentiation of P. falciparum and P. vivax malaria.


    SUMMARY:


    Malaria is a mosquito-borne, hemolytic, febrile illness that infects over 200 million people and kills more than 1 million people per year. It is caused by four species of Plasmodium: P. falciparum, P. vivax, P. ovale, and P. malariae. These plasmodia all infect and destroy human erythrocytes, producing chills, fever, anemia, and splenomegaly. P. falciparum causes more sever disease than the other plasmodial species and accounts for most malaria deaths. P. falciparum and P. vivax are the most common pathogens, however, there is considerable geographic variation in species distribution1.


    Traditionally, malaria is diagnosed by the demonstration of the organisms on Giemsa stained smears of peripheral blood, and the different species of plasmodium are distinguished by their appearance in infected erythrocytes1. The technique is capable of accurate and reliable diagnosis, but only when performed by skilled microscopists using defined protocols2, which presents major obstacles for the remote and poor areas of the world.




    TEST PRINCIPLE



    A capture monoclonal antibody is immobilized on the membrane within the cassette. The red blood cells are lysed releasing Pf. HRP11 and P. vivax specific pLDH which binds selectively to this antibody as the blood flows along the strip inside the cassette. The signal reagent is coated with specific antibodies, which bind with the antibody-antigen complex, producing a black line. The presence of an upper black line (the control line) demonstrates the test has been performed correctly.



    TEST PROCEDURE


    1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.


    2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.


    3.Dispense 1 drop (10µl) of whole blood to the “S” well of the test cassette using the plastic pipette provided, according to the illustrations below.



    4. Add three drops of Sample Diluent to the “D” well after the specimen is added and absorbed.



    5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.
    Caution: The above interpreting time is based on room temperature range of 15 - 30°C. If your room temperature is significantly lower than15 °C, then the interpreting time should be properly increased to 30 minutes.



    INTERPRETATION OF RESULTS





    Malaria P.f Positive
    The control line and Malaria P.f line (T1) are visible in the result window. The test is positive for Malaria P.f.



    Malaria P.v Positive
    The control line and Malaria P.v line (T2) are visible in the result window. The test is positive for Malaria P.v.



    Malaria P.f and Malaria P.v Positive


    The control line, Malaria P.f (T1) and Malaria P.v (T2) lines are visible in the result window. The test is positive for Malaria P.f and Malaria P.v.



    Negative


    The control line is the only line visible in the result window. No Malaria P.f or Malaria P.v has been detected.



    Invalid
    If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.



    Performance Study


    The following data was generated from previously frozen whole blood samples and was determined by correlation to standard thick and thin smear microscopic examination with discrepancies evaluated via PCR. Retrospective study results are summarized below:


    SitePosNegTest PosTest Neg
    India668664 (97%)86 (100%)
    Senegal8108 (100%)10 (100%)
    Varied Origin485346 (95.8%)53 (100%)
    South Africa10215099 (97%)149 (99.3%)
    TOTAL224299217 (96.9%)298 (99.7%)

    ORIENT NEW LIFE MEDICAL CO., LTD.
    Contact:Jerry Meng
    Email:Jerry @ newlifebiotest .com
    Tel.+86 18657312116
    SKYPEenetjerry
    Quality Tri - Line Home Medical Test Kits 95% Accuracy Detecting Malaria PF/PV Antigen for sale
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