Helicobacter Pylori Antibody Home Test One Step Hpab Rapid Test Kits

• Type:Pathological Analysis Equipments
• Packing:25 tests/box or As requested
• Specimen:Blood
• Format:Multi Panel
• Accuracy:99.8%
• Keywords:Hp-ab,hp-ag
• Package:Single Pouch + Carton
• Power Source:Electric
• Warranty:2 years
• After-sale Service:Onsite Training
• Material:Plastic
• Shelf Life:2 years
• Quality Certification:ce
• Instrument classification:Class II
• Safety standard:EN 149 -2001+A1-2009
• Place of Origin:CN;FUJ
• Model Number:HP-Ab
• Brand Name:Wiz

Helicobacter Pylori Antibody Home Test One Step Hpab Rapid Test Kits

For in vitro diagnostic use only 

Please read this package insert carefully prior to use and strictly follow the instructions. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert.

INTENDED USE

Diagnostic Kit for Antibody to Helicobacter Pylori (Fluorescence Immunochromatographic Assay)is a fluorescence immunochromatographic assay for the quantitative detection of HP antibody in human serum or plasma. which is important auxiliary diagnostic value for gastric infections.All positive sample must be confirmed by other methodologies. This test is intended for healthcare professional use only.

SUMMARY

Gastric helicobacter pylori infection is closely related with chronic gastritis, gastric ulcer, gastric adenocarcinoma, gastric mucosa associated lymphoma, H.p ylori infection rate of about 90% in gastritis, gastric ulcer, duodenal ulcer and gastric cancer patients. WHO has identified h. pylori as the first type of cancer-causing factor.it is a risk factor for gastric cancer.H.pylori detection is of great value in the diagnosis of h. pylori infection.

PRINCIPLE OF THE PROCEDURE

The membrane of the test device is coated with HP antigen on the test region and goat anti rabbit IgG antibody on the control region. Lable pad are coated by fluorescence labeled HP antigen and rabbit IgG in advance. When testing positive sample, the HP antibody in sample combine with fluorescence labeled HP antigen, and form immune mixture. Under the action of the immunochromatography, the complex flow in the direction of absorbent paper, when complex passed the test region, it combined with HP coating antigen, forms new complex.HP-Ab level is positively correlated with fluorescence signal, and the concentration of HP-Ab in sample can be detected by fluorescence immunoassay assay

REAGENTS AND MATERIALS SUPPLIED

25T package components:

Test card individually foil pouched with a desiccant 25T

Sample diluents 25T

Package insert 1

MATERIALS REQUIRED BUT NOT PROVIDED

Sample collection container, timer

SAMPLE COLLECTION AND STORAGE

1. The samples tested can be serum, heparin anticoagulant plasma or EDTA anticoagulant plasma.

2. According to standard techniques collect sample. Serum or plasma sample can be kept refrigerated at 2-8℃ for 7days and cryopreservation below -15°C for 6 months. 

3. All sample avoid freeze-thaw cycles.

ASSAY PROCEDURE

Please read the instrument operation manual and package insert before testing.

1. Lay aside all reagents and samples to room temperature.

2. Open the Portable Immune Analyzer(WIZ-A101), enter the account password login according to the operation method of the instrument, and enter the detection interface.

3. Scan the identification code to confirm the test item.

4. Take out the test card from the foil bag.

5. Insert the test card into the card slot, scan the QR code, and determine the test item.

6. Add 20μL serum or plasma sample to sample diluent, and mix well..

7. Add 80μL sample solution to sample well of the card.

8. Click the"standard test"button, after 15 minutes, the instrument will automatically detect the test card, it can read the results from the display screen of the instrument, and record/print the test results.