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AltoStar® BKV 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® BKV 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 BK Virus (BKV) specific DNA
  • Ready-to-use Kit including Quantification Standards
  • Quantification Standards calibrated against the 1 st WHO International Standard for BK Virus for Nucleic Acid Amplification Techniques (NAT) (NIBSC code 14/212)
  • 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® BKV PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of BKV specific DNA in human plasma and whole blood. The AltoStar® BKV PCR Kit 1.5 is configured for use with the CFX96™ Deep Well Real-Time PCR Detection 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® BKV PCR Kit 1.5 CE

Order No.AS0031513
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® BKV PCR Kit 1.5 have to be interpreted in conjunction with other clinical and laboratory findings. The AltoStar® BKV PCR Kit 1.5 is intended for use by professional users trained in molecular biological techniques.

AltoStar® BKV PCR Kit 1.5 CE

Instructions for use AltoStar® BKV PCR Kit 1.5 CE

pdf
Release Date: 06/2019
Filesize: 15.03 MB

Instruções de uso AltoStar® BKV PCR Kit 1.5 CE

pdf
Data de lançamento: 06/2019
Filesize: 3.87 MB

AltoStar® BKV PCR Kit 1.5 CE

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

pdf
Release Date: 19.04.2018
Filesize: 75.12 KB