Kits not available in all countries. Products not licensed with Health Canada and not FDA cleared or approved.
Intended use
The FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection and differentiation of norovirus genogroup I (GI), norovirus genogroup II (GII) and rotavirus specific RNA in human stool specimens. It is intended to be used as an aid for diagnosis of norovirus and rotavirus infection. Validated for use with the AltoStar® Automation System AM16 for nucleic acid extraction, the AltoStar® Internal Control 1.5 and the FlexStar® (RT-)PCR Amplification Mix 1.5.
Specifications
Key features
- For detection and differentiation of norovirus genogroup I (GI), norovirus genogroup II (GII) and rotavirus specific RNA
- Parallel detection of norovirus GI, norovirus GII and rotavirus specific RNA in a single reaction
- CE-IVD marked in vitro diagnostic test
- Analytical sensitivity reported in copies/ml
Limit of detection (LoD)
| LoD norovirus GI |
5,939 copies/ml |
| LoD norovirus GII | 5,228 copies/ml |
| LoD rotavirus | 11,133 copies/ml |
Sample types
The following sample type is validated for use with the FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5:
- Human stool
For use with
CFX96™ Deep Well Dx System (Bio-Rad)
CFX96™ Dx System (Bio-Rad)
Rotor-Gene® Q5/6 plex Platform (QIAGEN)
QuantStudio™ 5 Real-Time PCR System (Roche)
