RoboGene HBV DNA Quantification Kit 3.0

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

 

Improved sensitivity

 

Streamlined workflow with RoboGene HCV RNA Quantification Kit 3.0

Intended use

The RoboGene HBV DNA Quantification Kit 3.0 is intended for real-time PCR quantification of Hepatitis B Virus (HBV) DNA in human EDTA- or citrate plasma and serum samples. For specimen purification, the manual method (using the INSTANT Virus RNA/DNA Kit) as well as the automated method (using the INSTANT Virus RNA/DNA Kit - FX) is validated. For amplification and detection the RoboGene HBV DNA Quantification Kit 3.0 is validated in combination with the following real-time PCR devices: qTOWER 2 & 3; CFX96; LightCycler® 480; 7500 Fast, Rotor-Gene® 3000/6000/Q, RealLine Cycler 48 / 96 and QuantStudio 5 Real-Time-PCR System. The assay is purposed for the clinical management of patients with Hepatitis B in conjunction with clinical presentation and other laboratory markers for HBV infection.

This test is intended to evaluate viral response to antiviral treatment as measured by changes of HBV DNA levels in plasma and serum. Furthermore, in the course of antiviral therapy the probability of a sustained viral response can be assessed.

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

qTOWER 2 & 3 (Analytik Jena)

CFX 96 touch (Biorad)

LightCycler® 480 (Roche)

7500 Fast (Applied Biosystems)

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

RealLine Cycler 48 / 96

QuantStudio 5

Specifications

LoD with manual purification: 7.3 IU/ml

LoD with automated purification: 6.1 IU/ml

Linear range: 9 to 2,5x109 IU/ml

Genotypes: A - I

Order information

Item number   Kit size
847-0207710032   32 reactions
847-0207710096   96 reactions
847-0207710192   192 reactions

 

Downloads

ATTENTION! Please, check which revision level of the instruction for use applies to your kit. The applicable revision level is indicated on the product label of the kit packaging. You can download the latest version of the IFU here. For older revision levels please get in contact with us.