HBV reagent kit AltoStar®

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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. 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 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.