CE 99.6% H Pylori Antibody Rapid Test Infectious Disease Rapid Test Kits

Brand Name:Aichek
Certification:CE
Model Number:HP-A01
Minimum Order Quantity:5000 Test
Payment Terms:T/T
Place of Origin:China
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Location: Hangzhou Zhejiang China
Address: 3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District, 310018 Hangzhou, Zhejiang, P.R. China
Supplier`s last login times: within 41 hours
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Product Details

Infection Disease H.Pylori antibody Rapid Test with CE certificate

Product Name

Infection Disease H.Pylori antibody Rapid Test

FormatsStrip(3mm)Device(4mm)
Place of OrigenChina
SpecimenBlood
Read Time15 minutes
Shelf life2 years
Package25 device/box or 50 strip/Box
Storage2℃-30℃

For professional in vitro diagnostic use only.


INTENDED USE


The H.Pylori Ab Rapid Test Device (Whole Blood/Serum/ Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to H.Pylori in whole blood, serum or plasma to aid in the diagnosis of H.Pylori infection.


INTRODUCTION


H.Pylori is a small, spiral-shaped bacterium that lives in the surface of the stomach and duodenum. It is implicated in the etiology of a variety of gastrointestinal diseases, including duodenal and gastric ulcer, non-ulcer dyspepsia and active and chronic gastritis. 1,2 Both invasive and non-invasive methods are used to diagnose H.Pylori infection in patients with symptoms of gastrointestinal disease. Specimen-dependent and costly invasive diagnostic methods include gastric or duodenal biopsy followed by urease testing (presumptive), culture, and/or histologic staining.3 Non-invasive techniques include the urea breath test, which requires expensive laboratory equipment and moderate radiation exposure, and serological methods.4,5 Individuals infected with H.Pylori develop serum antibodies which correlate strongly with histologically confirmed H.Pylori infection.6,7,8

The H.Pylori Ab Rapid Test Device (Whole Blood/Serum/ Plasma) is a simple test that utilizes a combination of H.Pylori antigen coated particles and anti-human IgG to qualitatively and selectively detect H.Pylori antibodies in whole blood, serum, or plasma in just minutes.


PERFORMANCE CHARACTERISTICS


Table: H. pylori Rapid Test vs. Biopsy/Histology/RUT

Relative Sensitivity: >95.0% (90.0%-97.9%)*

Relative Specificity: >95.7% (92.3%-97.9%)*

Overall Agreement: >95.4% (92.8%-97.3%)*

*95% Confidence Interval

H.Pylori Rapid Test
+-Total

Biopsy/

Histology/

RUT

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China CE 99.6% H Pylori Antibody Rapid Test Infectious Disease Rapid Test Kits supplier

CE 99.6% H Pylori Antibody Rapid Test Infectious Disease Rapid Test Kits

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