Machine Use Antigen to Helicobacter Pylori Detection Kit

Short Description:

Diagnostic Kit for Antigen to Helicobacter Pylori

Methodology: Fluorescence Immunochromatographic Assay

  • Testing time: 15 minutes
  • Storage temperature: 2°C-30°C
  • Valid Time: 24 months
  • Accurancy: More than 99%
  • Specification: 25 test/box
  • Product Detail

    Product Tags


    This kit is intended for in vitro qualitative detection of helicobacter pylori antigen in human stool sample, which is for evaluation of helicobacter pylori infection. This kit only provides detection result of helicobacter pylori antigen, and results obtained shall be used in combine with other clinical information for analysis. It must only be used by healthcare professionals.


    Model No. HP-AG
    Methodology Fluorescence Immunochromatographic Assay
    Sample Type faeces
    Time to Result 10-15mins
    Storage 2~30 ℃/36~86℉
    Shelf Life 24 months
    Certificate ISO13485,CE,MHRA

    * Test device

    * Sample diluents

    * Disposable pipette

    * Instructions for Use


    * 25 test /kit

    * Aluminum foil bag labeling

    * shrink wrap


    1 Please read the instructions carefully before use, and operate in strict accordance with the requirements of the instructions to ensure the accuracy of the results. Make sure balance the test device and specimen to room temperature (15°C~30°C) prior to test.
    2 Ⅰ Select standard detection mode of Portable Immune Analyzer (WIZ-A101)
    3 I-1: Use of portable immune analyzer
    4 Open the reagent aluminum foil bag and take out the test card;
    5  Insert the test card into the slot of Analyzer horizontally;
    6 On the homepage of the operation interface on Analyzer, click "Standard" to enter the detection interface;
    7 On the homepage of the operation interface on Analyzer, click "Standard" to enter the detection interface;
    8 Click "QC scan" to scan the QR code inside the kit box and input the relevant parameters of the kit into the instrument;
    Note: each production batch number reagent should be scanned once. If this batch number has been scanned, this step can be omitted.
    9 Check the consistency of “Product Name”, “Batch Number” etc. on test interface with information on the kit marker.
    10 Start to add sample in case of consistent information:
    Remove the cap of sampling tube, discard the first two drops of diluted sample, add 3 drops (approx. 100μL) of bubble-free diluted sample dropwise to well of test device vertically and slowly;
    11 After complete sample addition, click “Timing” and remaining test time will be automatically displayed on the
    12 Immune analyzer will automatically complete test and analysis when test time is reached.
    13 Ⅰ-2: Result calculation and display
    After test by immune analyzer is completed, test result will be displayed on test interface or can be viewed through
    “History” on home page of operation interface.


    Clinical performance of this product’s assessed through collection of 296 cases of clinical samples. Sample providers include patients infected with helicobacter pylori and normal subjects. Marketed kit of turbidimetric inhibition immunoassay’s used as reference reagent, and BAYSEN  reagent detection’s compared with reference reagent.

    Baysen Resultsof HP-AG Test result of Reference reagent Positive coincidence rate:
    98.82% (95%C.I. 95.81%~99.68%)
    Negative coincidence rate:
    100.00% (95%C.I. 97.04%~100.00%)
    Total coincidence rate:
    99.32% (95%C.I. 97.57%~99.81%)
    Positive  Negative  Total
    Positive  168  0 168
    Negative  126 128
    Total  170  126 296


    * ISO System Certificate

    * CE Certificate

    * EU Registration

    * UCKA MHRA Registration

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