The AltoStar® RT-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® HCV RT-PCR Kit 1.5 is designed for reliable viral load monitoring of HCV infected patients.
AltoStar® HCV RT-PCR Kit 1.5
AltoStar® HCV RT-PCR Kit 1.5
Product not licensed with Health Canada and not FDA cleared or approved. Kit not available in all countries.
Key features
Detection and quantification of hepatitis C virus (HCV) specific RNA
Detection of genotypes 1 to 6 in human EDTA plasma and serum
Quantification Standards calibrated against the 5th WHO International Standard for HCV NAT (NIBSC code: 14/150)
CE-IVD marked in vitro diagnostic test
Analytical sensitivity reported in IU/ml
Limit of detection (LoD)
LoD human EDTA plasma
11.1 IU/ml
LoD human serum
at least 11.1 IU/ml
Sample types
The following sample types are validated for use with the AltoStar® HCV RT-PCR Kit 1.5:
Human EDTA plasma
Human serum
Intended use
The AltoStar® HCV RT-PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of human hepatitis C virus (HCV) specific RNA (genotypes 1 to 6) in human EDTA plasma and serum. The AltoStar® HCV RT-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® HCV RT-PCR Kit 1.5 is intended to be used for viral load monitoring in HCV infection.
