FlexStar® Norovirus Type & Rotavirus RT-PCR Detection
Mix 1.5
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. 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.


FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5 The FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5 consists of one Detection Mix, Positive Control (PC) and a No Template Control (NTC).
Kits not available in all countries. Products not licensed with Health Canada and not FDA cleared or approved.
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
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.
FlexStar® Norovirus Type & Rotavirus RT-PCR Detection
Mix 1.5
Order No. | FS0071543 |
Rxns | 96 |
Sample type | Human stool |
Transportation | Dry ice |
For use with | CFX96™ Deep Well Dx System CFX96™ Dx System Rotor-Gene® Q5/6 plex Platform QuantStudio™ 5 Real-Time PCR System |
FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5
Gebrauchsanweisung FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5
pdfRegulatorischer Status: | CE-IVD |
Veröffentlichungsdatum: | 05/2022 |
Instructions for use FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5
pdfRegulatory status: | CE-IVD |
Release date: | 05/2022 |
Statut réglementaire: | CE-IVD |
Date de sortie: | 05/2022 |
Instrucciones de uso FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5
pdfSituación reglamentaria: | CE-IVD |
Fecha de lanzamiento: | 05/2022 |
Instruções de utilização FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5
pdfEstatuto regulamentar: | CE-IVD |
Data de lançamento: | 05/2022 |
Istruzioni per l'uso FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5
pdfStato normativo: | CE-IVD |
Data di rilascio: | 05/2022 |
FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5
Konformitätserklärung/Declaration of conformity/Déclaration de conformité (DE, EN, FR)
pdfVeröffentlichungsdatum/Release date/Date de sortie: | 23.05.2022 |
Regulatorischer Status/Regulatory status/Statut réglementaire: | CE-IVD |
Declaración de conformidad/Dichiarazione di conformità/Declaração de conformidade (ES, IT, PT)
pdfFecha de lanzamiento/Data di rilascio/Data de lançamento: | 23.05.2022 |
Situación reglamentaria/Stato normativo/Estatuto regulamentar: | CE-IVD |