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.

 

 

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 B virus (HBV) specific DNA
  • Detection of genotypes A to H in human EDTA plasma
  • Quantification Standards calibrated against the 4th WHO International Standard for HBV DNA for nucleic acid amplification techniques (NIBSC code: 10/266)
  • CE-IVD marked in vitro diagnostic test
  • Analytical sensitivity reported in IU/ml

Limit of detection (LoD)

LoD human EDTA plasma
10.2 IU/ml

 

Sample types

The following sample type is validated for use with the AltoStar® HBV PCR Kit 1.5:

 

Human EDTA plasma

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
TransportationDry ice
Regulatory statusCE-IVD

AltoStar® HBV PCR Kit 1.5

Instructions for Use AltoStar® HBV PCR Kit 1.5

pdf
File size: 5.05 MB
Release date: 07/2021

Mode d'emploi AltoStar® HBV PCR Kit 1.5

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File size: 5.65 MB
Date de sortie: 07/2021

Instrucciones de uso AltoStar® HBV PCR Kit 1.5

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File size: 5.65 MB
Fecha de lanzamiento: 07/2021

Instruções de Utilização AltoStar® HBV PCR Kit 1.5

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File size: 5.69 MB
Data de lançamento: 07/2021

Istruzioni per l'uso AltoStar® HBV PCR Kit 1.5

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File size: 5.57 MB
Data di rilascio: 07/2021

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

pdf
File size: 231.06 KB
Poster: ESCV 2021

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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File size: 746.70 KB
Veröffentlichkeitsdatum: 05.11.2021

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

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File size: 517.60 KB
Veröffentlichkeitsdatum: 07.07.2020

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

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File size: 1.24 MB
Release Date: 05.11.2021

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

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File size: 752.47 KB
Release date: 07.07.2020

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

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File size: 1.44 MB
Date de sortie: 05.11.2021

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

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File size: 752.27 KB
Date de sortie: 07.07.2020

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

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File size: 1.15 MB
Fecha de lanzamiento: 05.11.2021

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

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File size: 656.53 KB
Fecha de lanzamiento: 07.07.2020

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

pdf
File size: 1.25 MB
Data de lançamento: 05.11.2021

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

pdf
File size: 742.32 KB
Data de lançamento: 07.07.2020

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

pdf
File size: 1.44 MB
Data di uscita: 05.11.2021

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

pdf
File size: 772.28 KB
Data di uscita: 07.07.2020

AltoStar® HBV PCR Kit 1.5

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

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File size: 295.11 KB
Veröffentlichungsdatum/Release date/Date de sortie: 13.08.2020

Fecha de lanzamiento/Data di rilascio/Data de lançamento

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

Info-Flyer AltoStar® HBV RT-PCR Kit 1.5

Automated testing for HIV and Hepatitis B and C Virus

pdf
File size: 1.70 MB
Release date: 11/2021