FlexStar(R) SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5

FlexStar(R) SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5

Order No FS0021515
Rxns 384
Transportation Dry ice
Regulatory status CE-IVD
SKU: FS0021515 Category: Tag:

THÔNG TIN MÔ TẢ

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

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)

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