AltoStar® HBV PCR Kit 1.5(CE-IVD)
AltoStar® HBV PCR Kit 1.5(CE-IVD) - Image 2

AltoStar® HBV PCR Kit 1.5(CE-IVD)

Order No AS0201513
Rxns 96
Transportation Dry ice
Regulatory status CE-IVD
Download Specification
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® HBV PCR Kit 1.5 is designed for reliable viral load monitoring of HBV infected patients.
Products not licensed with Health Canada and not FDA cleared or approved. Kits not available in all countries.

SKU: AS0201513 Category:

Description

Intended use

The AltoStar® HBV PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of human hepatitis B virus (HBV) specific DNA (genotypes A to H) in human EDTA plasma.

The AltoStar® HBV 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.

The AltoStar® HBV PCR Kit 1.5 is intended to be used for viral load monitoring in individuals with HBV infection.

Specifications

Key features

  • Detection and quantification of hepatitis B virus (HBV) specific DNA
  • Detection of genotypes A to H in human EDTA plasma
  • Quantification Standards calibrated against the 4th WHO International Standard for HBV DNA for nucleic acid amplification techniques (NIBSC code: 10/266)
  • CE-IVD marked in vitro diagnostic test
  • Analytical sensitivity reported in IU/ml

Limit of detection (LoD)

LoD human EDTA plasma 10.2 IU/ml

Sample types

The following sample type is validated for use with the AltoStar® HBV PCR Kit 1.5:

Human EDTA plasma

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