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RESPIRATORY DISEASES

Vstrip® Flu A&B Rapid Test

Rapid qualitative detection of influenza type A and type B antigens in human nasal specimens for in vitro diagnostic use.

Product Specifications

FEATURES

Method: Monoclonal immunochromatographic assay

Specimen: Nasopharyngeal swab

Detection device: Dipstick

Time to Result: 10 minutes

External Quality Control: Positive influenza A and influenza B control swab

Package: 20 tests/kit

Storage temperature: 15-30℃

 

PERFORMANCE CHARACTERISTICS

The analytical sensitivity was performed on 15 influenza strains; 12 influenza A virus (H1N1, H3N2, etc.) and 3 influenza B strains.
Lowest detectable limit:
Flu A H1N1 subtype: 1.0x104 TCID50/ml
Flu A H3N2 subtype: 1.0x103 TCID50/ml
Flu B subtype: 1.0x105 TCID50/ml

The evaluation was conducted comparing the nasopharyngeal swab sample results of Vstrip ® Flu A&B Rapid Test to a FDA-cleared commercial kit.  
                               Influenza A      Influenza B       
Sensitivity:                94.6%               85.7%
Specificity:                96.7%               99.0%
Accuracy:                 95.9%               98.9%
PPV:                         94.6%               99.0%
NPV:                         96.7%               98.9%

ANALYTICAL SPECIFICITY

The cross reactivity study was evaluated with a total of 15 bacteria strains and 5 viruses strains. None of these tested microorganisms gave a positive result.  

  

CERTIFICATION

ISO 13485

CE Mark

TFDA

Features & Benefits

Feature Benefit
Dipstick Have less operation steps
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