RoboGene HCV RNA Quantification Kit 3.0

CE-IvD certified for a wide range of real-time PCR devices

 

Improved sensitivity and reduced run time

 

Streamlined workflow with RoboGene HBV DNA Quantification Kit 3.0

Intended use

The RoboGene HCV RNA Quantification Kit 3.0 is intended for real-time PCR quantification of Hepatitis C Virus (HCV) RNA in human EDTA- or citrate plasma and serum samples. For specimen purification the manual method (INSTANT Virus RNA/DNA Kit) as well as the automated method (INSTANT Virus RNA/DNA Kit - FX) is validated. For amplification and detection the RoboGene HCV RNA Quantification Kit 3.0 is validated on the following real-time PCR devices: qTOWER 2 & 3; CFX96; LightCycler® 480; 7500 Fast and Rotor-Gene® 3000/6000/Q. The assay is purposed for the clinical management of patients with chronic HCV in conjunction with clinical presentation and other laboratory markers for HCV infection.

This test is intended to assess viral response to antiviral treatment as measured by changes in plasma and serum HCV RNA levels. Furthermore, in a course of antiviral therapy the probability of a sustained viral response can be judged.

The RoboGene HCV RNA Quantification Kit 3.0 is not intended for use as a screening test for the detection of HCV RNA in blood or blood products or as a diagnostic test to confirm the presence of HCV infection.

Status

CE-IvD

Validated extraction kits

Automization manual automized
Extraction kit name INSTANT Virus RNA/DNA Kit INSTANT Virus RNA/DNA Kit -FX
Sample volume 400 µl 800 µl
Sample specimen Plasma (EDTA, Citrate) and Serum Plasma (EDTA, Citrate) and Serum

 

Validated real-time PCR platforms

qTOWER³ (Analytik Jena)

CFX 96 touch (Biorad)

LightCycler® 480 (Roche)

7500 Fast (Applied Biosystems)

Rotor-Gene® 3000/6000/Q (Corbett Research/Qiagen)

Specifications

LoD with manual purification: 13.6 IU/ml

LoD with automated purification: 11.7 IU/ml

Linear range: 50 to 4x1010 IU/ml

Genotypes: 1-7

Order information

Item number Kit size
847-0207610032 32 reactions
847-0207610096 96 reactions
847-0207610192 192 reactions