FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5

The FlexStar® SARS-CoV-2 Type & FLU 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 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza virus specific RNA in human respiratory swab specimens. The SARS-CoV-2 detection is based on the parallel detection of the E gene of lineage B-beta coronavirus (including SARS-CoV-2) and the S gene of SARS-CoV-2. 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.

 

Products not licensed with Health Canada and not FDA cleared or approved. Kits not available in all countries.

Key features

  • For detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus
    specific RNA (E gene and S gene)
  • Dual target detection SARS-CoV-2
  • Parallel detection of SARS-CoV-2 virus and influenza virus A and B specific RNA in a single reaction
  • CE-IVD marked in vitro diagnostic test
  • Analytical sensitivity reported in IU/ml (SARS-CoV-2) and copies/ml (influenza virus A and B)

Limit of detection (LoD)

 

LoD E gene

226 IU/ml

LoD S gene

201 IU/ml

LoD Influenza A virus

341 copies/ml

LoD Influenza B virus

432 copies/ml

 

Sample types

The following sample type is validated for use with the FlexStar® SARS-CoV-2 Type & Flu RT-PCR Detetion Mix 1.5:

 

Human respiratory swab specimens

Intended use

The FlexStar® SARS-CoV-2 Type & FLU 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 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza virus specific RNA in human respiratory swab specimens. The SARS-CoV-2 detection is based on the parallel detection of the E gene of lineage B-beta coronavirus (including SARS-CoV-2) and the S gene of SARS-CoV-2.

The FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5 is intended to be used as an aid for diagnosis of SARS-CoV-2 and influenza virus infection.

FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5

Order No.FS0021515
Rxns384
TransportationDry ice
Regulatory statusCE-IVD
For use withLightCycler® 480 Instrument II
Rotor-Gene® Q5/6 plex Platform
CFX96™ Real-Time System
CFX96™ Deep Well Real-Time System

FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5

Gebrauchsanweisung FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5

pdf
File size: 641.26 KB
Regulatorischer Status: CE-IVD
Veröffentlichungsdatum: 02/2022

Instructions for use FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5

pdf
File size: 611.50 KB
Regulatory status: CE-IVD
Release date: 02/2022

Mode d'emploi FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5

pdf
File size: 661.76 KB
Statut réglementaire: CE-IVD
Date de sortie: 02/2022

Instrucciones de uso FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5

pdf
File size: 633.77 KB
Situación reglamentaria: CE-IVD
Fecha de lanzamiento: 02/2022

Instruções de Utilização FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5

pdf
File size: 649.30 KB
Estatuto regulamentar: CE-IVD
Data de lançamento: 02/2022

Istruzioni per l'uso FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5

pdf
File size: 638.34 KB
Stato normativo: CE-IVD
Data di rilascio: 02/2022

FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5

Konformitätserklärung/Declaration of conformity/Déclaration de conformité (DE, EN, FR)

pdf
File size: 568.47 KB
Veröffentlichungsdatum/Release date/Date de sortie: 01.03.2022
Regulatorischer Status/Regulatory status/Statut réglementaire: CE-IVD

Declaración de conformidad/Dichiarazione di conformità/Declaração de conformidade (ES, IT, PT)

pdf
File size: 583.94 KB
Fecha de lanzamiento/Data di rilascio/Data de lançamento: 01.03.2022
Situación reglamentaria/Stato normativo/Estatuto regulamentar: CE-IVD