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GASTROINTESTINAL DISEASES

Vstrip® H. pylori Antigen Rapid Test

Rapid qualitative detection of stool Helicobacter pylori antigen for in vitro diagnostic use

Product Specifications

FEATURES

Method: Monoclonal immunochromatographic assay

Specimen: Stool

Detection device: Cassette

Time to Result: 10 minutes

External Quality Control: Positive control reagent

Package: 20 tests/kit

Storage temperature: 15-30℃

 

PERFORMANCE CHARACTERISTICS

The analytical sensitivity was evaluated using 5 H. pylori strains including the Taiwan strain.
The lowest detectable limit of the Taiwan strain is 9.5 X103CFU/mL.

The evaluation was conducted comparing the results of Vstrip ® H. pylori Antigen Rapid Test to a FDA-cleared commercial kit.
Sensitivity:     96.5%    
Specificity:     98.9%     
Accuracy:      98.3%
PPV:              96.5%
NPV:              98.9%

 

ANALYTICAL SPECIFICITY

The cross reactivity study was evaluated with a total of 33 bacteria strains and 7 viruses strains. None of these tested microorganisms gave a positive result.  

 

CERTIFICATION

ISO 13485

CE Mark

TFDA

Features & Benefits

Feature Benefit
Cassette Provide more room for sample information
Spiral Sample Consistent and precise sampling
Results in 10 minutes Enable immediate treatment within minutes
Differential color results Offer easier interpretation and accurate reading
Built-in internal controls Verify proper procedure and test device function
External controls included Assure proper reagents and assay procedure
Room temperature storage Save space, time and cost : No need for refrigeration and warming up

Video

Product Documentation