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

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. 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 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

 

For use with

LightCycler® 480 Instrument II (Roche)
Rotor-Gene® Q5/6 plex Platform (QIAGEN)
CFX96™ Dx System (Bio-Rad)
CFX96™ Deep Well Dx System (Bio-Rad)

 

 

Order No
FS0021515
Rxns
384
Transportation
Dry ice
Regulatory status
CE-IVD

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

Manuals FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5
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Associated documents FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5
Download
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Manuals FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5
Language
FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5 - DE
Language: German
Date: 2022-02
Regulatory status: CE-IVD
FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5 - EN
Language: English
Date: 2022-02
Regulatory status: CE-IVD
FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5 - ES
Language: Spanish
Date: 2022-02
Regulatory status: CE-IVD
FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5 - FR
Language: French
Date: 2022-02
Regulatory status: CE-IVD
FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5 - IT
Language: Italian
Date: 2022-02
Regulatory status: CE-IVD
FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5 - PL
Language: Polish
Date: 2022-02
Regulatory status: CE-IVD
FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5 - PT
Language: Portuguese
Date: 2022-02
Regulatory status: CE-IVD
FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5 - VI
Language: Vietnamese
Date: 2022-02
Regulatory status: CE-IVD
Associated documents FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5
Language
Type of document
FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5 - DE - DoC
Language: German
Date: 2023-03-01
Panel: Respiratory infections
Regulatory status: CE-IVD
FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5 - EN - DoC
Language: English
Date: 2023-03-01
Panel: Respiratory infections
Regulatory status: CE-IVD
FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5 - ES - DoC
Language: Spanish
Date: 2023-03-01
Panel: Respiratory infections
Regulatory status: CE-IVD
FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5 - FR - DoC
Language: French
Date: 2023-03-01
Panel: Respiratory infections
Regulatory status: CE-IVD
FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5 - IT - DoC
Language: Italian
Date: 2023-03-01
Panel: Respiratory infections
Regulatory status: CE-IVD
FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5 - PT - DoC
Language: Portuguese
Date: 2023-03-01
Panel: Respiratory infections
Regulatory status: CE-IVD
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