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.


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 consists of: One Detection Mix, Positive Control (PC) and a No Template Control (NTC).
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 |
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 |
FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5
Regulatorischer Status: | CE-IVD |
Veröffentlichungsdatum: | 02/2022 |
Instructions for use FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5
pdfRegulatory status: | CE-IVD |
Release date: | 02/2022 |
Statut réglementaire: | CE-IVD |
Date de sortie: | 02/2022 |
Instrucciones de uso FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5
pdfSituación reglamentaria: | CE-IVD |
Fecha de lanzamiento: | 02/2022 |
Instruções de utilização FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5
pdfEstatuto regulamentar: | CE-IVD |
Data de lançamento: | 02/2022 |
Istruzioni per l'uso FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5
pdfStato normativo: | CE-IVD |
Data di rilascio: | 02/2022 |
🇵🇱 Instrukcja użytkowania FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5
pdfStatus prawny: | CE-IVD |
Data wydania: | 02/2022 |
🇻🇳 Hướng dẫn sử dụng FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5
pdfTình trạng pháp lý: | CE-IVD |
Ngày ban hành: | 02/2022 |
FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5
Konformitätserklärung/Declaration of conformity/Déclaration de conformité (DE, EN, FR)
pdfVeröffentlichungsdatum/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)
pdfFecha de lanzamiento/Data di rilascio/Data de lançamento: | 01.03.2022 |
Situación reglamentaria/Stato normativo/Estatuto regulamentar: | CE-IVD |