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.
AltoStar® HBV PCR Kit 1.5
AltoStar® HBV PCR Kit 1.5
Products not licensed with Health Canada and not FDA cleared or approved. Kits not available in all countries.
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
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.
