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AltoStar® HCV RT-PCR Kit 1.5 CE

 

The AltoStar® RT-PCR Kit 1.5 is developed for the simultaneous testing of pathogens by harmonized cycling conditions and enabling the identification of clinical pathogen using the AltoStar® Molecular Diagnostic Workflow. The AltoStar® HCV RT-PCR Kit 1.5 is part of the pathogen panel for testing immunocompromised patients.

 

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

Key Features

  • Detection, Quantification and Differentiation for the detection and quantification of hepatitis C virus (HCV) specific RNA
  • Detection of genotypes 1 to 6 in human EDTA plasma
  • Ready-to-use Kit including Quantification Standards
  • Quantification Standards calibrated against the 5th WHO International Standard for HCV NAT (NIBSC code: 14/150)
  • Analytical sensitivity reported in IU/ml
  • Mixed batches possible: all sample types in parallel
  • Simultaneous processing: up to 8 assays in the same run
  • CE-IVD marked in vitro Diagnostic Test

Intended Use

 

The AltoStar® HCV RT-PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR
technology, for the detection and quantification of hepatitis C virus (HCV) specific RNA
(genotypes 1 to 6) in human EDTA plasma. The AltoStar® HCV RT-PCR Kit 1.5 is configured
for use with the CFX96™ Deep Well Real-Time PCR Detection System (Bio-Rad) in
combination with the AltoStar® Automation System AM16, the AltoStar® Purification Kit 1.5 and
the AltoStar® Internal Control 1.5.

AltoStar® HCV RT-PCR Kit 1.5 CE

Order No.AS0211513
Rxns96
Sample TypesHuman EDTA plasma
TransportationDry ice
For use withAltoStar® Automation System AM16 / AltoStar® Connect Software
AltoStar® Purification Kit 1.5
AltoStar® Internal Control 1.5
CFX96™ Deep Well Real-Time PCR Detection System-IVD

The results generated with the AltoStar® HCV RT-PCR Kit 1.5 have to be interpreted in conjunction with other clinical and laboratory findings. The AltoStar® HCV RT-PCR Kit 1.5 is intended for use by professional users trained in molecular biological techniques.

AltoStar® HCV RT-PCR Kit 1.5 CE

Manual Instruction AltoStar® HCV RT-PCR Kit 1.5 CE

pdf
Release Date: 11/2018
Filesize: 3.16 MB

AltoStar® HCV RT-PCR Kit 1.5 CE - Certificates

AltoStar® HCV PCR Kit 1.5 CE - EG-Zertifikat-QM-System_CMV-HCV (EN)

pdf
Veröffentlichkeitsdatum: 06.12.2018
Filesize: 243.11 KB

AltoStar® HCV PCR Kit 1.5 CE -EG-Zertifikat-Auslegungsprüfbescheinigung_HCV (DE)DE

pdf
Veröffentlichkeitsdatum: 06.12.2018
Filesize: 231.23 KB

AltoStar® HCV PCR Kit 1.5 CE - Certificate_Annex IV 98-79 CE_CMV_HCV (EN)

pdf
Release Date: 06.12.2018
Filesize: 242.17 KB

AltoStar® HCV PCR Kit 1.5 CE - EC Design Examination Certificate_HCV (EN

pdf
Release Date: 06.12.2018
Filesize: 231.98 KB

AltoStar® HCV PCR Kit 1.5 CE - Certificat_Annex IV 98-79 CE_CMV_HCV (FR)

pdf
Date de sortie: 06.12.2018
Filesize: 240.71 KB

AltoStar® HCV PCR Kit 1.5 CE - Certificat d'examen CE de la conception_HCV (FR)

pdf
Date de sortie: 06.12.2018
Filesize: 231.04 KB

AltoStar® HCV PCR Kit 1.5 CE - Certificado_Annex IV 98-79 CE_CMV_HCV (ES)

pdf
Fecha de lanzamiento: 06.12.2018
Filesize: 243.85 KB

AltoStar® HCV PCR Kit 1.5 CE - Certificado de examen CE del diseño_HCV (ES)

pdf
Fecha de lanzamiento: 06.12.2018
Filesize: 232.12 KB

AltoStar® HCV PCR Kit 1.5 CE - Certificado_Annex IV 98-79 CE_CMV_HCV (PT)

pdf
Data de lançamento: 06.12.2018
Filesize: 271.71 KB

AltoStar® HCV RT-PCR Kit 1.5 CE

Konformitätserklärung/Declaration of Conformity/Déclaration de conformité - DE, EN, FR

pdf
Release Date: 06.12.2019
Filesize: 573.68 KB