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GeneProof Hepatitis B Virus (HBV) PCR Kit

CE 1023 IVD

PRODUCT ADVANTAGES

 

HIGH SPECIFICITY

  • Secured by targeting the DNA conservative sequence of ORFx
  • Prevents detection failure caused by the occurrence of mutations (including safe detection of core and pre-core mutants)
  • Detection of all HBV genotypes A – H
  • 100% diagnostic specificity

HIGH SENSITIVITY

  • Ensures excellent sensitivity up to 13.9 IU/ml
  • 100% diagnostic sensitivity

W.H.O. STANDARD BASED QUANTIFICATION

  • Precise and fully traceable quantification according to 4th WHO International Standard NIBSC 10/266

EASY-TO-USE CONCEPT

  • Single tube Ready-to-Use Master Mix contains all components for PCR amplification
  • No additional PCR reagents pipetting necessary

CONTAMINATION PREVENTION

  • Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating carryover contamination

 

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE1023IVD CERTIFIED DIAGNOSTIC TEST

Order information

Product name Catalog no. Technology Packaging
GeneProof Hepatitis B Virus (HBV) PCR Kit HBV/ISEX/025 real-time PCR 25 reactions
GeneProof Hepatitis B Virus (HBV) PCR Kit HBV/ISEX/100 real-time PCR 100 reactions

EQA Panels

EQA results

; GP_HBV_QCMD_04_22_EN
pdf, [188.4 kB]
; GP_HBV_Instand_03_22_EN
pdf, [1.06 MB]
; GP_HBV_QCMD_08_21_EN
pdf, [189.09 kB]
; GP_HBV_Instand_03_21_EN
pdf, [1.02 MB]
Choose all

Technical specification

Indication in vitro diagnostic medical device
Regulatory Status CE1023 IVD 
Intended User For professional use in laboratories with trained staff
Technology Real-time PCR
Type of Analysis

Qualitative and quantitative

Target Sequence

DNA conservative sequence of open reading frame X (ORFx)

Analytical Specificity

HBV genotype A-H, precore mutants HBV (HBeAg negative), 100 %

Analytical Sensitivity 

(LoD with the probability of 95 %)

36.9792 IU/ml (on HBV NIBSC 05/148 using GeneProof PathogenFree DNA Isolation Kit),
64.067 IU/ml (on HBV NIBSC 10/266 using croBEE 201A Nucleic Acid Extraction Kit),
13.9 IU/ml (on HBV NIBSC 10/266 using manual extraction SpinStar Viral Nucleic Acid Kit 1.0 with SpinStar Pretreatment Solution)
Diagnostic Specificity

100% (CI95% : 99.06% – 100%)

Diagnostic Sensitivity  100% (CI95% : 95.90% – 100%)
Linear Range

1010 – 102 IU/ml with precision of ± 0.5 log

Dynamic Range

1010 – 36.9792 IU/ml (using GeneProof PathogenFree DNA Isolation Kit)
1010 – 64.067 IU/ml (using croBEE 201A Nucleic Acid Extraction Kit)

Reporting Units

IU/ml

Metrological Traceability

HBV NIBSC 10/266 (4th WHO International Standard)

Validated Specimen Plasma, serum
Storage -20 ± 5 °C
Validated Extraction Method croBEE 201A Nucleic Acid Extraction Kit
GeneProof PathogenFree DNA Isolation Kit
Validated Instruments

croBEE Real-Time PCR System
AMPLilab Real-Time PCR System
Applied Biosystems 7300 / 7500 Real-Time PCR System
AriaMx Real-Time PCR System
BioQuant-96 Real-Time PCR System
CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System
DT lite Real-Time PCR System
LightCycler® 2.0 / 480
LineGene 9600 / 9600 Plus
Mic qPCR Cycler
QuantStudioTM 3 / 5 Real-Time PCR System
Rotor-Gene 3000 / 6000 / Q
SLAN® Real-Time PCR System
StepOneTM/StepOne PlusTM Real-Time PCR System

Required Detection Channels FAM, HEX
External Quality Assessment Regularly tested in QCMD and Instand e.V. External Quality Assessment Panels – results at www.geneproof.com

Documentation

Instruction for Use

; Declaration of Verification of the kits with medical devices
pdf, [1.61 MB]
; GP_HBV_Advisory Notice_EN
pdf, [466.14 kB]
; GP_HBV_Advisory_Notice_05_22_EN
pdf, [554.48 kB]
; GP_HBV_Instruction for Use_EN
pdf, [225.36 kB]
; GP_HBV_Manual de Uso_ES
pdf, [208.12 kB]
; GP_HBV_Mode d'emploi_FR
pdf, [225.12 kB]

Declaration of Conformity

; GP_EC_Full_Quality_Assurance_Certificate_EN
pdf, [417.58 kB]
; GP_HBV_Declaration_of_Conformity_EN
pdf, [604.59 kB]
; GP_HBV_EC_Design_Examination_Certificate_EN
pdf, [358.79 kB]

MSDS

; GP_HBV_Safety_Data_Sheet_EN
pdf, [278.5 kB]

PCR Template

; GP_DNA_3CH_2CH_ABI7500
edt, [10.72 kB]
; GP_DNA_3CH_2CH_AriaMx
amxt, [3.61 kB]
; GP_DNA_3CH_2CH_croBEE
fqt, [4.91 kB]
; GP_DNA_3CH_2CH_QS5
edt, [8.14 kB]
; GP_DNA_BioRad
prcl, [1.33 kB]
; GP_HBV_Mic
micassay, [13.84 kB]
; GP_HBV_template_AmpliLAB
tlpi, [3.04 kB]
; RG_DNA_2CH_3CH_4CH
ret, [13.83 kB]

Product Leaflet

; GP_HBV_Leaflet_EN
pdf, [141.88 kB]

Manual

; AriaMx Real-Time PCR System_EN
pdf, [2.31 MB]
; Bio-Rad CFX 96/Connect/Dx Real-Time PCR Detection System_EN
pdf, [1.43 MB]
; LightCycler 2.0_EN
pdf, [1.8 MB]
; LightCycler 480/480 Instrument II_EN
pdf, [2.18 MB]
; LineGene 9600_9600Plus_K_EN
pdf, [4.6 MB]
; Mic qPCR Cycler_CZ
pdf, [2.5 MB]
; Mic qPCR Cycler_EN
pdf, [2.33 MB]
; QuantStudio 3/5 Real-Time PCR System_EN
pdf, [1.81 MB]
; Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]
; SLAN Real-Time PCR System_EN
pdf, [1.56 MB]
; StepOne/StepOne Plus Real-Time PCR System_EN
pdf, [4.42 MB]
; ThermoFisher ABI 7500/7500 Fast Real-Time PCR System_EN
pdf, [4.2 MB]
Files are available only for registered users.

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