AltoStar® HCV RT-PCR Kit 1.5

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.

Specifications

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 5^th 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

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