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IVD Infections diseases H.Pylori antibody diagnostic rapid test cassette H.Pylori antibody rapid test kit CE certificate

Categories Rapid Test Kits
Brand Name: Assure
Model Number: HP-P11
Certification: CE
Place of Origin: China
MOQ: 1200 PCS
Price: $0.40
Delivery Time: 25 working days after payment
Packaging Details: 40pcs per box,1200 pcs per carton
test format: Strip
specimen: Serum/Plasma
expiry date: 24 months
function: rapid test
storage: 2-30 centigrade
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    IVD Infections diseases H.Pylori antibody diagnostic rapid test cassette H.Pylori antibody rapid test kit CE certificate

    IVD Infections diseases H.Pylori Antibody diagnostic rapid test cassette H.Pylori Antibody rapid test kit CE certificate​

    Product NameProduction Information
    Catalog No.Specimen UsedTest FormatKit Size
    H.Pylori AntibodyHP-P11Serum/PlasmaStrip50 pcs / box
    HP-W11Whole blood/Serum/PlasmaStrip50pcs / box
    HP-W23Device40 pcs /box

    Intended Use of H. pylori Antibody Rapid Test Device


    The H. pylori Antibody Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of specific IgM and IgG antibodies to Helicobacter pylori in human whole blood, serum, or plasma specimens. This kit is intended for use as an aid in the diagnosis of H. pylori infection.


    Principle of H. pylori Antibody Rapid Test Device


    The H. pylori Antibody Rapid Test Device (Whole Blood/Serum/Plasma) detects IgM and IgG antibodies specific to Helicobacter pylori through visual interpretation of color development on the internal strip. H. pylori antigens are immobilized on the test region of the membrane. During testing, the specimen reacts with H. pylori antigen conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If there are sufficient antibodies to Helicobacter pylori in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.


    Procedure and Result Reading of H. pylori Antibody Rapid Test Device


    1. Bring all materials and specimens to room temperature.

    2. Remove test device from the sealed foil pouch.

    3. Place the test device on a flat dry surface.

    4. Using the provided plastic dropper, dispense a drop of whole blood (about 30μl of sample) to the sample pad of Strip or Sample well(S) of the test card, then add 2 full drops of buffer (approximately 60 uL). Start timing.

    5. Read result between 5 to 10 minutes after adding the sample.


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