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

Categories Infectious Disease Rapid Test Kits
Brand Name: Aichek
Model Number: HP-A01
Certification: CE
Place of Origin: China
MOQ: 5000 Test
Price: negotiable
Payment Terms: T/T
Supply Ability: negotiable
Packaging Details: 40box/carton
Storage: 2℃-30℃
Sample Type: Blood
User: Professional
Accuracy: 99.6% (97.7%-99.9%)
Certificate: CE ISO 13485
OEM: OEM customized packing avaliable
Formats: 25T/box 1T/box
After-sales Service: Available
Key words: Infection Disease H.Pylori antigen Rapid Test with CE certificate
For the crowd: Preliminary screening of infected people
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CE 99.6% H Pylori Antibody Rapid Test Infectious Disease Rapid Test Kits

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

+1317138
-10225235
141232373
Quality CE 99.6% H Pylori Antibody Rapid Test Infectious Disease Rapid Test Kits for sale
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