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.
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 hepatitis C virus (HCV) specific RNA (genotypes 1 to 6) in human EDTA plasma.
The AltoStar® HCV RT-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).
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
Ready-to-use kit including Quantification Standards
Quantification Standards calibrated against the 5th WHO International Standard for HCV NAT (NIBSC code: 14/150)
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® 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. 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.
AltoStar® HCV RT-PCR Kit 1.5
Order No.
AS0211513
Rxns
96
Sample Types
Human EDTA plasma
Transportation
Dry ice
For use with
AltoStar® 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® HCV RT-PCR Kit 1.5 have to be interpreted in conjunction with other clinical and laboratory findings. The AltoStar® HCV RT-PCR Kit 1.5 is intended for use by professional users trained in molecular biological techniques.
