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 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
Rxns	384
Transportation	Dry ice
Regulatory status	CE-IVD
For use with	LightCycler^® 480 Instrument II Rotor-Gene^® Q5/6 plex Platform CFX96™ Dx System CFX96™ Deep Well Dx System