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AltoStar® CMV PCR Kit 1.5 CE

 

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® CMV PCR Kit 1.5 is part of the pathogen panel for testing immunocompromised 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 Cytomegalovirus (CMV) specific DNA
  • Ready to use Kit including Quantification Standards
  • Quantification Standards calibrated against the 1st WHO International Standard for Human Cytomegalovirus for Nucleic Acid Amplification Techniques (NAT) (NIBSC code: 09/162)
  • 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® CMV PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of human cytomegalovirus (CMV) specific DNA in human plasma and whole blood. The AltoStar® CMV PCR Kit 1.5 is configured for use with the CFX96™ Deep Well Real-Time PCR Detection System (IVD, Bio-Rad) in combination with the AltoStar® Automation System AM16, the AltoStar® Purification Kit 1.5 and the AltoStar® Internal Control 1.5.

AltoStar® CMV PCR Kit 1.5 CE

Order No.AS0021513
Rxns96
Sample TypesHuman EDTA plasma
Human citrate plasma
Human EDTA whole blood
Human citrate whole blood
TransportationDry ice
For use withAltoStar® Automation System AM16 / AltoStar® Connect Software
AltoStar® Purification Kit 1.5
AltoStar® Internal Control 1.5
CFX96™ Deep Well Real-Time PCR Detection System-IVD

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

AltoStar® CMV PCR Kit 1.5 CE

Instructions for use AltoStar® CMV PCR Kit 1.5 CE

pdf
Release Date: 11/2018
Filesize: 3.54 MB

Mode d'emploi AltoStar® CMV PCR Kit 1.5 CE

pdf
Date de sortie: 11/2018
Filesize: 4.64 MB

AltoStar® CMV PCR Kit 1.5 CE

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

pdf
Release Date: 19.04.2018
Filesize: 75.61 KB