Rapid qualitative detection of stool Rotavirus antigen for in vitro diagnostic use.
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 because no need for refrigeration and warming up again |
FEATURES
Method: Monoclonal immunochromatographic assay
Specimen: Stool
Detection device: Dipstick
Time to Result: 10 minutes
External Quality Control: Positive control swab
Package: 20 tests/kit
Storage temperature: 15-30℃
PERFORMANCE CHARACTERISTICS
The analytical sensitivity was evaluated using 2 Rotavirus strains.
Lowest detectable limit:
Rotavirus /Hu/Australia/102510/77/L : 8.89X102 TCID50/mL
Rotavirus /HRV 89-12C2 : 1.58X103 TCID50/mL
ANALYTICAL SPECIFICITY
The cross reactivity study was evaluated with a total of 15 bacteria strains and 20 viruses strains. None of these tested microorganisms gave a positive result.
CERTIFICATION
ISO 13485:2016
CE Mark
TFDA