Intended use

RoboGene HBV DNA Quantification Kit 3.1 is a non-automated in vitro diagnostic test, based on real-time PCR technology, for quantification of Hepatitis B Virus (HBV) DNA (genotypes A-H) in human EDTA-plasma samples.

RoboGene HBV DNA Quantification Kit 3.1 is intended for quantification of HBV DNA as an aid in the management of patients with HBV infection undergoing antiviral therapy.

All results must be interpreted within the context of all relevant clinical and laboratory findings.

RoboGene HBV DNA Quantification Kit 3.1 has not been approved as a screening test for the presence of HBV in blood or blood products.

RoboGene HBV DNA Quantification Kit 3.1 is intended for use by professional users trained in molecular biological techniques and in vitro diagnostic procedures.

Status

CE-IVD

Validated extraction kits

Automization		manual
Extraction kit name		INSTANT Virus RNA/DNA Kit
Sample volume		400 µl
Sample specimen		Plasma (EDTA)

Validated real-time PCR platforms

qTOWER³

CFX96 TouchReal-Time PCR Detection System

LightCycler® 480 II System

7500 Fast Real-Time PCR System

Rotor-Gene® 3000

Specifications

LoD with manual purification: 7.3 - 10.4 IU/ml

Linear range: 8.0 - 2.5E+09 IU/ml

Genotypes: A - H

Order information

Item number		Kit size
847-0207720032		32 reactions
847-0207720096		96 reactions
847-0207720192		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.