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AltoStar® BKV 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. The AltoStar® BKV PCR Kit 1.5 is part of the pathogen panel for testing immunocompromised patients.

  • 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, whole blood and urine. 
  • The AltoStar® BKV PCR Kit 1.5 consists of: Two Master reagents (Master A and Master B), Four Quantification Standards (QS1 - QS4) and a No Template Control (NTC). 

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 BK virus specific DNA in human plasma, whole blood and urine. The AltoStar® BKV 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® BKV PCR Kit 1.5

Order No.AS0031513
Rxns96
Sample TypesHuman EDTA plasma
Human citrate plasma
Human EDTA whole blood
Human citrate whole blood
Human urine
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® 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

Instructions for use AltoStar® BKV PCR Kit 1.5

pdf
Release Date: 09/2020
Filesize: 5.14 MB

Mode d'emploi AltoStar® BKV PCR Kit 1.5

pdf
Date de sortie: 09/2020
Filesize: 5.93 MB

Instruções de uso AltoStar® BKV PCR Kit 1.5

pdf
Fecha de lanzamiento: 09/2020
Filesize: 5.85 MB

Instruções de Utilização AltoStar® BKV PCR Kit 1.5

pdf
Data de lançamento: 09/2020
Filesize: 5.95 MB

Istruzioni per l'uso AltoStar® BKV PCR Kit 1.5

pdf
Data di rilascio: 09/2020
Filesize: 5.94 MB

AltoStar® BKV PCR Kit 1.5

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

pdf
Veröffentlichungsdatum/Release date/ Date de sortie: 21.02.2020
Filesize: 545.93 KB

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

pdf
Fecha de lanzamiento/Data di rilascio/Data de lançamento: 21.02.2020
Filesize: 556.80 KB

Info brochure AltoStar® Immunocompromised PCR Panel

Automated Real-Time Efficiency in Monitoring Immunocompromised Patients

pdf
Release date: 06/2020
Filesize: 267.46 KB