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