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RealStar® SARS-CoV-2 RT-PCR Kit 1.0

 

The RealStar® SARS-CoV-2 RT-PCR Kit 1.0 is an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection of lineage B-betacoronavirus (B-βCoV) and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) specific RNA.

 

It is intended to be used as an aid for diagnosis in individuals with signs and symptoms of coronavirus disease 2019 (COVID-19) in conjunction with clinical and epidemiological risk factors.

 

The RealStar® SARS-CoV-2 RT-PCR Kit 1.0 is intended to be used by qualified personnel in appropriately equipped laboratories following the guidelines on laboratory biosafety.

The assay is available in two different configurations!

  • RealStar® SARS-CoV-2 RT-PCR Kit 1.0 (384 reactions) 
  • RealStar® SARS-CoV-2 RT-PCR Kit 1.0 (384er) consists of: Eight Master reagents (Master A and Master B), Internal Control (2x IC), Positive Control (2x), PCR grade water (2x). 
  • The RealStar® RealStar® SARS-CoV-2 RT-PCR Kit 1.0: Configuration 4800 reactions 

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

Key Features

  • Detection of lineage B-betacoronavirus (β-ßCoV) and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) specific RNA
  • Ready to use Kit including Internal Control and Positive Control for both targets, B-βCoV and SARS-CoV-2
  • These tests can be run in parallel: RealStar® Influenza Screen & Type RT-PCR Kit 4.0, RealStar® PIV RT-PCR Kit 2.0, RealStar® RSV RT-PCR Kit 3.0, RealStar® hMPV RT-PCR Kit 2.0
  • Compatible with various real-time PCR platforms
  • CE-IVD marked in vitro Diagnostic Test
Different concentrations of SARS-CoV-2 specific RNA are detected by the pan lineage B beta-coronaviruses detection system (E gene) in the FAM channel [A] and the SARS-CoV-2 specific detection system (S Gene) in the Cy5 Channel [B]. The Internal Control (IC) is detected in the JOE detection channel [C]. Green: SARS-CoV-2 specific RNA; Red: Positive Control; Blue: No Template Control.

RealStar® SARS-CoV-2 RT-PCR Kit 1.0

Prod. No821015
Rxns384
TransportationDry ice
For use withMx 3005P™ QPCR System
VERSANT® kPCR Molecular System AD
ABI Prism® 7500 SDS
ABI Prism® 7500 Fast SDS
LightCycler® 480 Instrument II
Rotor-Gene® 6000
Rotor-Gene® Q 5/6 plex Platfom
CFX96™ Deep Well Real-Time PCR Detection System
CFX96™ Real-Time PCR Detection System

RealStar® SARS-CoV-2 RT-PCR Kit 1.0

Prod. No821019
Rxns4800
TransportationDry ice
For use withMx 3005P™ QPCR System
VERSANT® kPCR Molecular System AD
ABI Prism® 7500 SDS
ABI Prism® 7500 Fast SDS
LightCycler® 480 Instrument II
Rotor-Gene® 6000
Rotor-Gene® Q 5/6 plex Platfom
CFX96™ Deep Well Real-Time PCR Detection System
CFX96™ Real-Time PCR Detection System

RealStar® SARS-CoV-2 RT-PCR Kit 1.0

Instructions for use RealStar® SARS-CoV-2 RT-PCR Kit 1.0

pdf
Release Date: 05/2020
Filesize: 531.15 KB

Instructions for use RealStar® SARS-CoV-2 RT-PCR Kit 1.0 (4800 rxn)

pdf
Release Date: 06/2020
Filesize: 534.01 KB

Mode d'emploi RealStar® SARS-CoV-2 RT-PCR Kit 1.0

pdf
Date de sortie: 05/2020
Filesize: 566.47 KB

Mode d'emploi RealStar® SARS-CoV-2 RT-PCR Kit 1.0 (4800 rxn)

pdf
Date de sortie: 06/2020
Filesize: 569.74 KB

Instrucciones de uso RealStar® SARS-CoV-2 RT-PCR Kit 1.0

pdf
Fecha de lanzamiento: 05/2020
Filesize: 561.45 KB

Instrucciones de uso RealStar® SARS-CoV-2 RT-PCR Kit 1.0 (4800 rxn)

pdf
Fecha de lanzamiento: 06/2020
Filesize: 562.09 KB

Instruções de uso RealStar® SARS-CoV-2 RT-PCR Kit 1.0

pdf
Data de lançamento: 05/2020
Filesize: 569.57 KB

Instruções de uso RealStar® SARS-CoV-2 RT-PCR Kit 1.0 (4800 rxn)

pdf
Data de lançamento: 06/2020
Filesize: 569.75 KB

Istruzioni per l'uso RealStar® SARS-CoV-2 RT-PCR Kit 1.0

pdf
Data di rilascio: 05/2020
Filesize: 553.02 KB

Istruzioni per l'uso RealStar® SARS-CoV-2 RT-PCR Kit 1.0 (4800 rxn)

pdf
Data di rilascio: 06/2020
Filesize: 553.16 KB

References RealStar® SARS-CoV-2 RT-PCR Kit

Rapid establishment of laboratory diagnostics for the novel coronavirus SARS-CoV-2 in Bavaria, Germany, February 2020

pdf
Rapid communication/Eurosurveillance: 05.03.2020
Filesize: 196.87 KB

RealStar® RealStar® SARS-CoV-2 RT-PCR Kit 1.0

Konformitätserklärung/Declaration of Conformity (DoC)/Déclaration de conformité RealStar® SARS-CoV-2 RT-PCR Kit 1.0 (DE, EN, FR)

pdf
Veröffentlichungsdatum/Release date/Date de sortie: 26.05.2020
Filesize: 294.38 KB

Declaración de conformidad/Dichiarazione di Conformità/Declaração de conformidade RealStar® SARS-CoV-2 RT-PCR Kit 1.0 (ES, IT, PT)

pdf
Fecha de lanzamiento/Data di rilascio/Data de lançamento: 26.05.2020
Filesize: 301.48 KB

Konformitätserklärung/Declaration of Conformity (DoC)/Déclaration de conformité RealStar® SARS-CoV-2 RT-PCR Kit 1.0 - 4800 (DE, EN, FR)

pdf
Veröffentlichungsdatum/Release date/Date de sortie: 17.06.2020
Filesize: 294.01 KB

Declaración de conformidad/Dichiarazione di Conformità/Declaração de conformidade RealStar® SARS-CoV-2 RT-PCR Kit 1.0 - 4800 (ES, IT, PT)

pdf
Fecha de lanzamiento/Data di rilascio/Data de lançamento: 17.06.2020
Filesize: 296.19 KB

Flyer SARS-CoV-2 RT-PCR Kit 1.0 - 384 rxns

pdf
Release Date: 06/2020
Filesize: 383.11 KB

Flyer SARS-CoV-2 RT-PCR Kit 1.0 - 4800 rxns

pdf
Release Date: 06/2020
Filesize: 416.08 KB