AltoStar® HEV 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 pathogens using the AltoStar® Molecular Diagnostic Workflow.

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 E virus (HEV) specific RNA
  • Ready-to-use kit including Quantification Standards
  • Quantification Standards calibrated against the 1st WHO International Standard for hepatitis E virus RNA nucleic acid amplification techniques (NAT)-based assays (PEI code: 6329/10)
  • 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® HEV RT-PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of hepatitis E virus (HEV) specific RNA in human plasma. The AltoStar® HEV 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® HEV RT-PCR Kit 1.5

Order No.AS0271513
Rxns96
Sample typesHuman EDTA plasma
Human citrate 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® HEV RT-PCR Kit 1.5 have to be interpreted in conjunction with other clinical and laboratory findings. The AltoStar® HEV RT-PCR Kit 1.5 is intended for use by professional users trained in molecular biological techniques.

AltoStar® HEV RT-PCR Kit 1.5

Instructions for use AltoStar® HEV RT-PCR Kit 1.5

pdf
Release Date: 09/2020
Filesize: 5.67 MB

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

pdf
Date de sortie: 09/2020
Filesize: 5.95 MB

Instrucciones de uso AltoStar® HEV RT-PCR Kit 1.5

pdf
Fecha de lanzamiento: 09/2020
Filesize: 6.00 MB

Instruções de Utilização AltoStar® HEV RT-PCR Kit 1.5

pdf
Data de lançamento: 09/2020
Filesize: 6.04 MB

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

pdf
Data di rilascio: 09/2020
Filesize: 6.00 MB

AltoStar® HEV RT-PCR Kit 1.5

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

pdf
Veröffentlichungsdatum/Release date/Date de sortie: 06.10.2020
Filesize: 290.11 KB

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

pdf
Fecha de lanzamiento/Data di rilascio/Data de lançamento: 06.10.2020
Filesize: 297.05 KB