Malaria P.f Gold Rapid Screen Test Kit

Short Description:

1.Jiqing offers CE authorized Malaria P.f Gold Rapid Screen Test.
2.2.Quick Results
3.Detects Presence of antigen to Malaria in human body.
4.Made Start to Finish in China at CE Registered Facilities


  • Size: 1 Test/Kit,4 Tests/Kit, 6 Tests/Kit, 20 Tests/Kit, 50 Tests/Kit
  • Product Detail

    Product Tags

    Intended us

    Malaria is a serious, sometimes fatal, 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 (called sporozoites) migrate to the liver where they mature and release another form, the merozoites. The disease is a major health problem in much of the tropics and subtropics. More than 200 million people in the world have malaria.

    At the present, malaria is diagnosed by looking for the parasites in a drop of blood. Blood will be put onto a microscope slide and stained so that the parasites will be visible under a microscope. At the most recent, clinical diagnostic issues related to malaria are the detection of malaria antibodies in human blood or serum by immunoassay. The ELISA format and immunochromatographic format (rapid) to detect antibody of malaria are available recently.

    Test Principle

    The Malaria P.f test is a immunochromatographic (rapid) test for the qualitative detection of antibodies of all isotypes (IgG, IgM, IgA) specific to Plasmodium falciparum and Plasmodium vivax simultaneously in human serum, plasma or whole blood.

    Main composition

    1. Test card 2. Disposable alcohol cotton pad 3. Disposable blood collection needle 4. Diluent
    Storage conditions and validity
    1.Store at 4℃~40℃,the validity period is tentatively set for 24 months.
    2.After opening the aluminum foil bag, the test card should be used as soon as possible within 30 minutes. The sample diluent should be capped immediately after opening and placed in a cool place. Please use it within the validity period.

    Specimen Request

    1. whole blood : Collect the whole blood using the suitable anti-coagulant.
    2. serum or plasma: Centrifuge whole blood to get plasma or serum specimen.
    3. If specimens are not immediately tested they should be refrigerated at 2 ~ 8°C. For storage periods greater than three days, freezing is recommended. They should be brought to room temperature prior to use.
    4. Specimens containing precipitate may yield inconsistent test results. Such specimens must be clarified prior to assaying.
    5. The whole blood may be used for testing immediately or may be stored at 2 ~ 8°C up to three days.

    Testing method

    Please read the instruction Instruction for Use carefully before testing. The samples to be tested, detection reagents and other materials used for testing need to be equilibrated to room temperature. The test should be performed at room temperature.
    1.Remove the test paper card by tearing the aluminum foil bag, and lay it flat on the operation surface.
    2.First use a plastic pipette to aspirate 1 drop of whole blood, serum or plasma sample (approximately 10μ1) into the sample well (S) of the test card. Then add 2 to 3 drops (about 50 to 100 μl) of sample dilution
    3.Observe the experimental results within 5-30 minutes (the results are invalid after 30 minutes).
    Caution: The above interpreting time is based on reading the test results at room temperature of 15 ~ 30°C. If your room temperature is significantly lower than 15°C, then the interpreting time should be properly increased.

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    Interpretation of test results

    Positive:The colored line in the control line region (C) appears and a colored line appears in test line region(T). The result is positive.
    Negative:The colored line in the control line region (C) appears and no colored line appears in test line region(T).The result is negative.
    Invalid: There is no line appeared in the C region.
    Invalid: There is no line appeared in the C region.

    Limitations of inspection methods

    1. The test is limited to the detection of antibodies to Malaria both Plasmodium falciparum and Plasmodium vivax simultaneously. Although the test is very accurate in detecting antibodies to Malaria P.f, a low incidence of false results can occur. Other clinically available tests are required if questionable results are obtained. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
    2. The test results of this product are interpreted by human eyes, and are susceptible to factors such as visual inspection errors or subjective judgments. Therefore, it is recommended to repeat the test when the color of the band is not easy to determine.
    3. This reagent is a qualitative detection reagent.
    4.This reagent is used for the detection of personal serum, plasma or whole blood samples. Do not use it for the detection of saliva, urine or other body fluids

    PERFORMANCE CHARACTERISTICS
    1. Sensitivity and Specificity: The Malaria P.f test have tested with positive and negative clinical samples tested by microscopic examination of whole blood.
    Malaria P.f evaluation results

    Reference

    Malaria P.f

    Total Results

    Method

    Result

    Positive (T)

    Negative

    microscopic examination

    P.f Positive

    150

    20

    170

    P.f Negative

    3

    197

    200

    Total Results

    153

    217

    370

    In a comparison of the Malaria P.f test versus microscopic examination of whole blood, results gave sensitivity of 88.2% (150/170), a specificity of 98.5% (197/200), and a total agreement of 93.8% (347/370).

    2. Precision
    Within run precision was determined by using 10 replicates of four different specimens containing different concentrations of antibody. The negative and positive values were correctly identified 100% of the time.
    Between run precision was determined by using the four different specimens containing different concentrations of antibody in 3 different replicates with 3 different lots of test devices. Again negative and positive results were observed 100% of the time.

    PROCAUTION

    1. For in vitro diagnostic use only.
    2. Do not eat or smoke while handling specimens.
    3. Wear protective gloves while handling specimens. Wash hands thoroughly afterwards.
    4. Avoid splashing or aerosol formation.
    5. Clean up spills thoroughly using an appropriate disinfectant.
    6. Decontaminate and dispose of all specimens, reaction kits and potentially contaminated materials, as if they were infectious waste, in a biohazard container.
    7. Do not use the test kit if the pouch is damaged or the seal is broken.

    【Index of CE Symbols】

    【Index of CE Symbols】


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