HBV Confirmation

The Confirmatory PCR Kit HBV is designed for the automated or manual confirmation testing of initially positive screening results.

Confirmatory PCR Kit HBV

The Confirmatory PCR Kit HBV is an in vitro diagnostic test kit for the qualitative analysis of Hepatitis B Virus (HBV) DNA in human EDTA plasma to confirm results from blood screening.

Sensitivity: 95% Limit of Detection (95% LOD) for autoX-System
Analyte
Reference material
Individual samples
sample volume 400 μl
HBV
WHO 2nd Int. Std.
97/750

Applied BiosystemsTM 7500: 5.4 IU/ml
Roche LightCycler® 480: 4.4 IU/ml
Sensitivity: 95% Limit of Detection (95% LOD) for manual handling
Analyte
Reference material
Individual samples
sample volume 380 μl
HBV
WHO 2nd Int. Std. 97/750

Roche LightCycler® 480 / MinElute: 3.2 IU/ml
Specificity, manual handling (Roche LightCycler® 480 / MinElute)
Analyte
Specificity
Pooled plasma samples100%
Individual samples100%
Genotype detection
VirusGenotype / Subtype
HBVA – H

For details please refer to the product information document.

Confirmatory PCR Kit HBV
Confirmatory PCR Kit HBV (version 1.0)
GFE order number
Number of reactions per kit


Automated handling (autoX-System)
manual handling

packing unit = 20 kits
004-08-20
8 analyses for 1 viruses
12 analyses for 1 viruses
Kit components:
Basismix
Oligomix HBV
Volume [µl]
810
100
Label
BM
O_B
Confirmatory PCR Kit HBV (version 1.0)
GFE order number
Number of reactions per kit


Automated handling (autoX-System)
Manual handling
packing unit = 20 kits
004-24-20
24 analyses for 1 viruses
28 analyses for 1 viruses
Kit components:
Basismix
Oligomix HBV
Volume [µl]
1640
228
Label
BM
O_B

Intended Use

The Confirmatory PCR Kit HBV is designed for the qualitative detection of Hepatitis B‑Virus (HBV) DNA in human EDTA plasma from blood donations. The kit allows for a highly sensitive analysis in accordance with Votum 34 of the German National Advisory Committee ‘Blood’ (Arbeitskreis Blut) of the German Federal Ministry of Health.

The kit is intended to confirm HBV positive screening results in human EDTA plasma samples by analysis of repository samples or consecutive blood samples of individual donors.

The Confirmatory PCR Kit HBV is intended for use with the Applied BiosystemsTM 7500 Real-Time PCR System or the Roche LightCycler® 480 II Real-Time PCR System in conjunction with the GFE autoX-System and the respective GFE accessory and control kits.

The Confirmatory PCR Kit HBV is also intended for use with the Roche LightCycler® 480 II Real-Time PCR System in conjunction with the QIAamp® MinElute® Virus Spin Kit for nucleic acid extraction and the respective GFE control kits (IC Kit, PCR Positive Control Kit, NTC Kit).

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