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AltoStar® HAV 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. The AltoStar® HAV RT-PCR Kit 1.5 is intended to be used as an aid for diagnosis of HAV infection.

 

Products not licensed with Health Canada and not FDA cleared or approved. Kits not available in all countries.

Key Features

  • Qualitative detection of hepatitis A virus (HAV) specific RNA
  • Ready-to-use kit including Positive Control
  • 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® HAV RT-PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection of human hepatitis A virus (HAV) specific RNA in human plasma. The AltoStar® HAV 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® HAV RT-PCR Kit 1.5

Order No.AS0241543
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® HAV RT-PCR Kit 1.5 have to be interpreted in conjunction with other clinical and laboratory findings. The AltoStar® HAV RT-PCR Kit 1.5 is intended for use by professional users trained in molecular biological techniques.

AltoStar® HAV RT-PCR Kit 1.5

Instructions for Use AltoStar® HAV RT-PCR Kit 1.5

pdf
Release Date: 08/2021
Filesize: 2.78 MB

Gebrauchsanweisung AltoStar® HAV RT-PCR Kit 1.5

pdf
Release Date: 08/2021
Filesize: 2.83 MB

AltoStar® HAV RT-PCR Kit 1.5

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

pdf
Veröffentlichungsdatum/Release date/ Date de sortie: 29.09.2021
Filesize: 540.55 KB

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

pdf
Fecha de lanzamiento/Data di rilascio/Data de lançamento: 29.09.2021
Filesize: 557.62 KB