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RESPIRATORY DISEASES

Vstrip® Strep A Rapid Test

Rapid qualitative detection of Group A streptococcus antigen in human throat specimens for in vitro diagnostic use.
 

Product Specifications

FEATURES

Method: Polyclonal immunochromatographic assay

Specimen: Throat swab

Detection device: Dipstick

Time to Result: 5 minutes

External Quality Control: Positive and negative control reagent

Package: 20 tests/kit

Storage temperature: 15-30℃

 

PERFORMANCE CHARACTERISTICS

The analytical sensitivity was evaluated using 3 Group A Streptococcus strains.

Lowest detectable limit:

Group A Streptococcus/ATCC 19615 : 1x104 org/swab or 2.5x 105 org/ml

Group A Streptococcus/ATCC 14289 : 1x106 org/swab or 2.5x 107 org/ml

Group A Streptococcus/ATCC 12344 : 1x106 org/swab or 2.5x 107 org/ml


ANALYTICAL SPECIFICITY

The cross reactivity study was evaluated with a total of 14 bacteria strains and 20 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 5 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