RoboGene HBV DNA Quantification Kit 3.0

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 and Rotor-Gene^® 3000/6000/Q. 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.

CE-IvD

qTOWER³ (Analytik Jena)

CFX 96 touch (Biorad)

LightCycler® 480 (Roche)

7500 Fast (Applied Biosystems)

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

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

• Instruction for use available soon
• Declaration of Conformity
• CE certificate