AltoStar® HBV PCR Kit 1.5

 

The AltoStar® 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® HBV PCR Kit 1.5 is designed for reliable viral load monitoring of HBV 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 B virus (HBV) specific DNA
  • Detection of genotypes A to H in human EDTA plasma
  • Ready-to-use kit including Quantification Standards
  • Quantification Standards calibrated against the 4th WHO International Standard for HBV DNA for nucleic acid amplification techniques (NIBSC code: 10/266)
  • 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® HBV PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of human hepatitis B virus (HBV) specific DNA (genotypes A to H) in human EDTA plasma.

The AltoStar® HBV 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® HBV PCR Kit 1.5

Order No.AS0201513
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 Dx System

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

AltoStar® HBV PCR Kit 1.5

Instructions for Use AltoStar® HBV PCR Kit 1.5

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Release Date: 09/2020
Filesize: 4.93 MB

Mode d'emploi AltoStar® HBV PCR Kit 1.5

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Date de sortie: 09/2020
Filesize: 5.53 MB

Instrucciones de uso AltoStar® HBV PCR Kit 1.5

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Fecha de lanzamiento: 09/2020
Filesize: 5.50 MB

Instruções de Utilização AltoStar® HBV PCR Kit 1.5

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Data de lançamento: 09/2020
Filesize: 5.54 MB

Istruzioni per l'uso AltoStar® HBV PCR Kit 1.5

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Data di rilascio: 09/2020
Filesize: 5.46 MB

References AltoStar® HBV RT-PCR Kit 1.5

Performance evaluation of the AltoStar® HBV PCR Kit 1.5 on the AltoStar® Automation System AM16 platform

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Poster: ESCV 2021
Filesize: 231.06 KB

AltoStar® HBV PCR Kit 1.5 - Certificates

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

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Veröffentlichkeitsdatum: 05.11.2021
Filesize: 746.70 KB

AltoStar® HBV PCR Kit 1.5 - EG-Zertifikat-Auslegungsprüfbescheinigung_HBV (DE)

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Veröffentlichkeitsdatum: 07.07.2020
Filesize: 517.60 KB

AltoStar® HBV PCR Kit 1.5 - Certificate_Quality System_Annex IV 98-79 CE CMV-HCV-HBV (EN)

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Release Date: 05.11.2021
Filesize: 1.24 MB

AltoStar® HBV PCR Kit 1.5 - EC Design Examination Certificate HBV (EN)

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Release Date: 07.07.2020
Filesize: 752.47 KB

AltoStar® HBV PCR Kit 1.5 - Certificate_Systeme de Qualite_Annex IV 98-79 CE CMV-HCV-HBV-HIV (FR)

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Date de sortie: 05.11.2021
Filesize: 1.44 MB

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

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Date de sortie: 07.07.2020
Filesize: 752.27 KB

AltoStar® HBV PCR Kit 1.5 - Certificate_Sistema de Calidad_Annex IV 98-79 CE CMV-HCV-HBV-HIV (ES)

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Fecha de lanzamiento: 05.11.2021
Filesize: 1.15 MB

AltoStar® HBV PCR Kit 1.5 - Certificado de examen CE del diseno HBV (ES)

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Fecha de lanzamiento: 07.07.2020
Filesize: 656.53 KB

AltoStar® HBV PCR Kit 1.5 - Certificate_Sistema de garantia de qualidade_Annex IV 98-79 CE CMV-HCV-HBV-HIV (PT)

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Data de lançamento: 05.11.2021
Filesize: 1.25 MB

AltoStar® HBV PCR Kit 1.5 - Certificado de exame CE de concepcao_HBV (PT)

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Data de lançamento: 07.07.2020
Filesize: 742.32 KB

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

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Data di uscita: 05.11.2021
Filesize: 1.44 MB

AltoStar® HBV PCR Kit 1.5 - Certificato di esame CE della progettazione_HBV (IT)

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Data di uscita: 07.07.2020
Filesize: 772.28 KB

AltoStar® HBV PCR Kit 1.5

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

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Veröffentlichungsdatum/Release date/Date de sortie: 13.08.2020
Filesize: 295.11 KB

Fecha de lanzamiento/Data di rilascio/Data de lançamento

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Fecha de lanzamiento/Data di rilascio/Data de lançamento: 13.08.2020
Filesize: 302.31 KB

Info-Flyer AltoStar® HBV RT-PCR Kit 1.5

Automated testing for HIV and Hepatitis B and C Virus

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Release date: 11/2021
Filesize: 1.70 MB