Standard
Phone
Tablet
Desktop
Large Desktop
Very Large Desktop
---

AltoStar® HCV RT-PCR Kit 1.5

 

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. The AltoStar® HCV RT-PCR Kit 1.5 is designed for reliable viral load monitoring of HCV infected patients.

 

Product not licensed with Health Canada and not FDA cleared or approved. Kit 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 and serum
  • 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 human hepatitis C virus (HCV) specific RNA (genotypes 1 to 6) in human EDTA plasma and serum. The AltoStar® HCV RT-PCR Kit 1.5 is configured for use with the CFX96™ Deep Well Dx 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

Order No.AS0211513
Rxns96
Sample typesHuman EDTA plasma
Human serum
TransportationDry ice
For use withAltoStar® Automation System AM16 / AltoStar® Connect software
AltoStar® Purification Kit 1.5
AltoStar® Internal Control 1.5
CFX96™ Deep Well Dx System

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

Instructions for Use AltoStar® HCV RT-PCR Kit 1.5

pdf
Release Date: 10/2020
Filesize: 5.49 MB

Mode d'emploi AltoStar® HCV RT-PCR Kit 1.5

pdf
Date de sortie: 10/2020
Filesize: 5.92 MB

Instrucciones de uso AltoStar® HCV RT-PCR Kit 1.5

pdf
Fecha de lanzamiento: 10/2020
Filesize: 5.89 MB

Instruções de Utilização AltoStar® HCV RT-PCR Kit 1.5

pdf
Data de lançamento: 10/2020
Filesize: 5.95 MB

Istruzioni per l'uso AltoStar® HCV RT-PCR Kit 1.5

pdf
Data di rilascio: 10/2020
Filesize: 5.90 MB

References AltoStar® HCV RT-PCR Kit 1.5

Performance evaluation of the novel AltoStar® HCV RT-PCR Kit 1.5 on the fully automated AltoStar®System

pdf
Poster: ESCV 2019
Filesize: 416.82 KB

AltoStar® HCV RT-PCR Kit 1.5 - Certificates

AltoStar® HCV RT-PCR Kit 1.5 - EG-Zertifikat-QM-System_CMV-HCV-HBV-HIV (DE)

pdf
Veröffentlichkeitsdatum: 03.02.2021
Filesize: 762.23 KB

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

pdf
Veröffentlichkeitsdatum: 06.12.2018
Filesize: 231.23 KB

AltoStar® HCV RT-PCR Kit 1.5 - Certificate_Annex IV 98-79 CE_CMV_HCV-HBV-HIV (EN)

pdf
Release Date: 03.02.2021
Filesize: 747.29 KB

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

pdf
Release Date: 06.12.2018
Filesize: 231.98 KB

AltoStar® HCV RT-PCR Kit 1.5 - Certificat_Annex IV 98-79 CE_CMV-HCV-HBV-HIV (FR)

pdf
Date de sortie: 03.02.2021
Filesize: 943.54 KB

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

pdf
Date de sortie: 06.12.2018
Filesize: 231.04 KB

AltoStar® HCV RT-PCR Kit 1.5 - Certificado_Annex IV 98-79 CE_CMV-HCV-HBV-HIV (ES)

pdf
Fecha de lanzamiento: 03.02.2021
Filesize: 657.18 KB

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

pdf
Fecha de lanzamiento: 06.12.2018
Filesize: 232.12 KB

AltoStar® HCV RT-PCR Kit 1.5 - Certificado_Annex IV 98-79 CE_CMV-HCV-HBV-HIV (PT)

pdf
Data de lançamento: 03.02.2021
Filesize: 753.98 KB

AltoStar® HCV RT-PCR Kit 1.5 - 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 -Certificate_Sistema di qualita_Annex IV 98-79 CE CMV-HCV-HBV-HIV (IT)

pdf
Data di uscita: 03.02.2021
Filesize: 944.05 KB

AltoStar® HCV RT-PCR Kit 1.5 - Certificato di esame CE della progettazione_HCV (IT)

pdf
Data di uscita: 06.12.2018
Filesize: 461.93 KB

AltoStar® HCV RT-PCR Kit 1.5

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

pdf
Veröffentlichungsdatum/Release date/ Date de sortie: 21.02.2020
Filesize: 551.99 KB

Declaración de conformidad/Dichiarazione di Conformità/Declaração de conformidade - ES, IT, PT

pdf
Fecha de lanzamiento/Data di rilascio/Data de lançamento: 21.02.2020
Filesize: 567.93 KB

Info-Flyer AltoStar® HCV RT-PCR Kit 1.5

Automated testing for HIV and Hepatitis B and C Virus

pdf
Release date: 09/2021
Filesize: 1.65 MB