Malaria PF Rapid Test Colloidal Gold with CE approval

short description:

Malaria PF Rapid Test Colloidal Gold

 


  • Testing time: 10-15 minutes
  • Valid Time: 24 month
  • Accurancy: More than 99%
  • Specification: 1/25 test/box
  • Storage temperature : 2℃-30℃
  • Methodology: Colloidal Gold
  • Product Detail

    Product Tags

    Malaria PF Rapid Test Colloidal Gold

    Production information

    Model Number  Malaria PF Packing 25 Tests/ kit, 30kits/CTN
    Name

    Malaria PF Rapid Test Colloidal Gold 

    Instrument  classification Class I
    Features High sensitivity, Easy opeation Certificate CE/ ISO13485
    Accuracy > 99% Shelf life Two Years
    Methodology Colloidal Gold OEM/ODM service Avaliable

     

    Test procedure

     1 Restore sample and kit to room temperature, take test device out of the sealed pouch, and lie it on horizontal bench.
     2 Pipette 1 drop (around 5μL) of whole blood sample into the well of test device (‘S’ well) vertically and slowly by the disposable pipette provided.
     3 Turn sample diluent upside down, discard first two drops of sample diluent, add 3-4 drops of bubble-free sample diluent dropwise to the well of test device (‘D’ well) vertically and slowly, and start counting time
     4 Result shall be interpreted within 15~ 20 minutes, and detection result is invalid after 20 minutes.

    Note:: each sample shall be pipetted by clean disposable pipette to avoid cross contamination.

    Intend Use

    This kit is applicable to in vitro qualitative detection of antigen to plasmodium falciparum histidine-rich proteins II (HRP II), and it’s used for auxiliary diagnosis of plasmodium falciparum (pf) infection. This kit only provides histidine-rich proteins II (HRP II) antigen detection result, and results obtained shall be used in combination with other clinical information for analysis. It must only be used by healthcare professionals.

    HIV

    Summary

    Malaria is caused by single-celled microorganisms of the plasmodium group, it’s normally spread by bites of mosquitos, and it’s an infectious disease that affects lives and life safety of human beings and other animals. Patients infected with malaria normally will have fever, fatigue, vomiting, headache and other symptoms, and severe cases may lead to xanthoderma, seizure, coma and even death. Malaria (P.F) Rapid Test can rapidly detect antigen to plasmodium falciparum histidine-rich proteins II that exits in whole blood, which can be used for auxiliary diagnosis of plasmodium falciparum (pf) infection.

     

    Feature:

    •  High sensitive

    •  result reading in 15 minutes

    •  Easy operation

    • Factory direct price

    • Do not need extra machine for result reading

     

    HIV rapiddiagnosis kit
    test result

    Result reading

    The WIZ BIOTECH reagent test will be compared with the control reagent:

    Reference Sensitivity  Specificity 
    Well-know reagent P.F.98.54%,Pan:99.2% 99.12%

     

    Sensitivity:P.F.98.54%,Pan.:99.2%

    Specificity:99.12%

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