RESPIRATORY DISEASES
Vstrip® Strep A Rapid Test
Rapid qualitative detection of Group A streptococcus antigen in human throat specimens for in vitro diagnostic use.
Rapid qualitative detection of Group A streptococcus antigen in human throat specimens for in vitro diagnostic use.
| Feature | Benefit |
| Cassette | Provide more room for sample information |
| 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 |
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 13485:2016
CE Mark
TFDA
