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
  • Quantification Standards calibrated against the 5th WHO International Standard for HCV NAT (NIBSC code: 14/150)
  • CE-IVD marked in vitro diagnostic test
  • Analytical sensitivity reported in IU/ml

Limit of detection (LoD)

LoD human EDTA plasma
11.1 IU/ml
LoD human serum at least 11.1 IU/ml

 

Sample types

The following sample types are validated for use with the AltoStar® HCV RT- PCR Kit 1.5:

 

Human EDTA plasma

Human serum

 

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
TransportationDry ice
Regulatory statusCE-IVD

AltoStar® HCV RT-PCR Kit 1.5

Instructions for Use AltoStar® HCV RT-PCR Kit 1.5

pdf
File size: 5.60 MB
Release date: 07/2021

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

pdf
File size: 5.92 MB
Date de sortie: 07/2021

Instrucciones de uso AltoStar® HCV RT-PCR Kit 1.5

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File size: 5.89 MB
Fecha de lanzamiento: 07/2021

Instruções de Utilização AltoStar® HCV RT-PCR Kit 1.5

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File size: 5.95 MB
Data de lançamento: 07/2021

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

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File size: 5.90 MB
Data di rilascio: 07/2021

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
File size: 416.82 KB
Poster: ESCV 2019

AltoStar® HCV RT-PCR Kit 1.5 - Certificates

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

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File size: 746.63 KB
Veröffentlichkeitsdatum: 13.05.2022

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

pdf
File size: 451.48 KB
Veröffentlichkeitsdatum: 23.05.2022

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

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File size: 1.24 MB
Release date: 13.05.2022

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

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File size: 705.39 KB
Release date: 23.05.2022

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

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File size: 1.43 MB
Date de sortie: 13.05.2022

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

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File size: 705.16 KB
Date de sortie: 23.05.2022

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

pdf
File size: 1.15 MB
Fecha de lanzamiento: 13.05.2022

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

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File size: 609.50 KB
Fecha de lanzamiento: 23.05.2022

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

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File size: 1.25 MB
Data de lançamento: 13.05.2022

AltoStar® HCV RT-PCR Kit 1.5 - Certificado de exame CE de concepcao_HCV (PT)

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File size: 695.13 KB
Data de lançamento: 23.05.2022

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

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File size: 1.43 MB
Data di uscita: 13.05.2022

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

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File size: 724.46 KB
Data di uscita: 23.05.2022

AltoStar® HCV RT-PCR Kit 1.5

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

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File size: 530.85 KB
Veröffentlichungsdatum/Release date/ Date de sortie: 24.05.2022

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

pdf
File size: 537.31 KB
Fecha de lanzamiento/Data di rilascio/Data de lançamento: 24.05.2022

Info-Flyer AltoStar® HCV RT-PCR Kit 1.5

Automated testing for HIV and Hepatitis B and C Virus

pdf
File size: 1.67 MB
Release date: 05/2022