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.

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
Rxns96
Sample typeHuman stool
TransportationDry ice
For use withCFX96™ 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

pdf
File size: 594.17 KB
Regulatorischer Status: CE-IVD
Veröffentlichungsdatum: 05/2022

Instructions for use FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5

pdf
File size: 574.22 KB
Regulatory status: CE-IVD
Release date: 05/2022

Mode d'emploi FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5

pdf
File size: 608.46 KB
Statut réglementaire: CE-IVD
Date de sortie: 05/2022

Instrucciones de uso FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5

pdf
File size: 582.00 KB
Situación reglamentaria: CE-IVD
Fecha de lanzamiento: 05/2022

Instruções de Utilização FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5

pdf
File size: 591.89 KB
Estatuto regulamentar: CE-IVD
Data de lançamento: 05/2022

Istruzioni per l'uso FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.5

pdf
File size: 581.81 KB
Stato 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)

pdf
File size: 521.43 KB
Veröffentlichungsdatum/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)

pdf
File size: 530.37 KB
Fecha de lanzamiento/Data di rilascio/Data de lançamento: 23.05.2022
Situación reglamentaria/Stato normativo/Estatuto regulamentar: CE-IVD