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AltoStar® HCV RT-PCR Kit 1.5 CE

 

The AltoStar® RT-PCR Kits 1.5 are developed for the simultaneous testing of pathogens by harmonized cycling conditions and enabling the identification of clinical pathogen using the AltoStar® Molecular Diagnostic Workflow.

 

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

Key Features

  • 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)

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 PCR Kit 1.5 CE - Certificado de exame CE de concepcao_HCV (PT)

pdf
Data de lançamento: 06.12.2018
Filesize: 228.80 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