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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.

 

  • 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 consists of: Two Master reagents (Master A and Master B), Four Quantification Standards (QS1 - QS4), PCR grade water. 

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

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

Manual Instruction AltoStar® HCV RT-PCR Kit 1.5

pdf
Release Date: 02/2020
Filesize: 5.21 MB

Instruções de uso AltoStar® HCV RT-PCR Kit 1.5

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Fecha de lanzamiento: 02/2020
Filesize: 5.56 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 (DE)

pdf
Veröffentlichkeitsdatum: 07.07.2020
Filesize: 776.03 KB

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

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Veröffentlichkeitsdatum: 06.12.2018
Filesize: 231.23 KB

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

pdf
Release Date: 07.07.2020
Filesize: 1.30 MB

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

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Release Date: 06.12.2018
Filesize: 231.98 KB

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

pdf
Date de sortie: 07.07.2020
Filesize: 1.49 MB

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 (ES)

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Fecha de lanzamiento: 07.07.2020
Filesize: 1.21 MB

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

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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 (PT)

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Data de lançamento: 07.07.2020
Filesize: 1.31 MB

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

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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 (IT)

pdf
Data di uscita: 07.07.2020
Filesize: 1.51 MB

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