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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.

 

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
  • 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 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

Manual Instruction AltoStar® HBV PCR Kit 1.5

pdf
Release Date: 06/2020
Filesize: 4.93 MB

AltoStar® HBV PCR Kit 1.5 - Certificates

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

pdf
Veröffentlichkeitsdatum: 07.07.2020
Filesize: 776.03 KB

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

pdf
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)

pdf
Release Date: 07.07.2020
Filesize: 1.30 MB

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

pdf
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 (FR)

pdf
Date de sortie: 07.07.2020
Filesize: 1.49 MB

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

pdf
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 (ES)

pdf
Fecha de lanzamiento: 07.07.2020
Filesize: 1.21 MB

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

pdf
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 (PT)

pdf
Data de lançamento: 07.07.2020
Filesize: 1.31 MB

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

pdf
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 (IT)

pdf
Data di uscita: 07.07.2020
Filesize: 1.51 MB

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

pdf
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

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

Fecha de lanzamiento/Data di rilascio/Data de lançamento

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