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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.

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

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

pdf
Release Date: 05/2020
Filesize: 531.15 KB

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

pdf
Date de sortie: 05/2020
Filesize: 568.73 KB

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

pdf
Fecha de lanzamiento: 05/2020
Filesize: 561.57 KB

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

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

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

pdf
Data di rilascio: 05/2020
Filesize: 553.02 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
Erscheinungsdatum/Release date/Date de sortie: 27.04.2020
Filesize: 297.58 KB

Declaración de conformidad RealStar® SARS-CoV-2 RT-PCR Kit 1.0 (ES, IT, PT)

pdf
Fecha de lanzamiento/Data di rilascio/Data de lançamento: 27.04.2020
Filesize: 304.22 KB