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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 analysis failure caused by the occurrence of mutations (including safe detection of core and pre-core mutants)
  • Detection of all HBV genotypes A – H

PRECISE QUANTITATIVE DETECTION

  • Precise and fully traceable quantification according to WHO International HBV DNA Standard NIBSC 10/266
  • Excellent results in EQA panel testing (QCMD, INSTAND)

CONTAMINATION ELIMINATION

  • Single tube Ready to use Master Mix contains Uracil DNA N-glycosylase (UNG) and dUTPs eliminating possible contamination with amplification product

HIGH SENSITIVITY

  • Sensitivity was established with certified strain (HBV NIBSC 10/266)
  • Ensures excellent sensitivity reaches up to 13.9 IU/ml

SINGLE TUBE READY-TO-USE MASTER MIX

  • Contains all components for PCR amplification
  • No additional pipetting of PCR reagentsnecessary
  • Reduces the need for qualified laboratory staff
  • Ensures reproducibility of results

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE IVD 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/050 real-time PCR 50 reactions
GeneProof Hepatitis B Virus (HBV) PCR Kit HBV/ISEX/100 real-time PCR 100 reactions

EQA Panels

EQA results

GP_HBV_QCMD_2020
pdf, [195.24 kB]
GP_HBV_QCMD_C1.2018_EN
pdf, [155.89 kB]
GP_HBV_QCMD_C3.2018_EN
pdf, [176.05 kB]
GP_HBV_QCMD_croBEE_2019_EN
pdf, [200.86 kB]
GP_HBV_SZU 2018_CZ
pdf, [275.28 kB]
GP_HBV_SZU 2019_CZ
pdf, [257.78 kB]
GP_Instand_03.2018_EN
pdf, [1.21 MB]
GP_Instand_03.2019_EN
pdf, [327.24 kB]
Choose all

Technical specification

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, pre-core mutants HBV  (HBeAg negative), 100% 

Analytical Sensitivity (LoD) reaches up to 36.9792 IU/ml with the probability of 95 % (on HBV NIBSC 05/148 using manual extraction
GeneProof PathogenFree DNA Isolation Kit)
reaches up to 64.067 IU/ml with the probability of 95% (on HBV NIBSC 10/266 using automatic extractor
croBEE NA16 Nucleic Acid Extraction System)
reaches up to 13.9 IU/ml with the probability of 95% (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% : 99.90% – 100%)
Linear Range

1010 – 102 IU/ml with precision of ± 0.5 log (using manual extraction GeneProof PathogenFree DNA Isolation
Kit or automatic extractor croBEE NA16 Nucleic Acid Extraction System)

Dynamic Range

1010 – 36.9792 IU/ml (using manual extraction GeneProof PathogenFree DNA Isolation Kit)
1010 – 64.067 IU/ml (using automatic extractor croBEE NA16 Nucleic Acid Extraction System)

Reporting Units

IU/µl

Conversion Factor

Not applicable

Metrological Traceability

HBV NIBSC 10/264

Extraction/Inhibition Control

PCR inhibition and DNA extraction efficiency control (ISEX version)

Validated Specimen plasma, serum
Storage -20 ± 5 °C
Validated Extraction Method croBEE NA16 Nucleic Acid Extraction System
GeneProof PathogenFree DNA Isolation Kit
Instruments

croBEE Real-Time PCR System*
Applied Biosystems 7300 / 7500 Real-Time PCR System
AriaMx 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
Quality Control quality management system is certified in compliance with the requirements of the standard ISO 13485
External Quality Assessment Regularly tested by QCMD and Instand e.V. External Quality Assessment Panels – results at www.geneproof.com
Certification CE1023 IVD 

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.4 MB]
GP_HBV_Advisory Notice_EN_CZ
pdf, [349.85 kB]
GP_HBV_Instruction for Use_CZ
pdf, [145.17 kB]
GP_HBV_Instruction for Use_EN
pdf, [106.44 kB]

Declaration of Conformity

GP_FQAS EC Certificate_CZ
pdf, [47.46 kB]
GP_FQAS EC Certificate_EN
pdf, [48.26 kB]
GP_HBV_Declaration of Conformity_CZ
pdf, [333.78 kB]
GP_HBV_Declaration of Conformity_EN
pdf, [345.57 kB]
GP_HBV_FQAS EC Certificate_CZ
pdf, [488.29 kB]
GP_HBV_FQAS EC Certificate_EN
pdf, [512.77 kB]

MSDS

GP_HBV_Safety Data Sheet_CZ
pdf, [580.85 kB]
GP_HBV_Safety Data Sheet_EN
pdf, [702.19 kB]

Manual

Applied Biosystems 7300/7500 Real-Time PCR System (SW 1.x.x)_CZ
pdf, [2.13 MB]
Applied Biosystems 7300/7500 Real-Time PCR System (SW 1.x.x)_EN
pdf, [2.03 MB]
Applied Biosystems 7500/7500 Fast Real-Time PCR System (SW 2.x.x)_CZ
pdf, [3.97 MB]
Applied Biosystems 7500/7500 Fast Real-Time PCR System (SW 2.x.x)_EN
pdf, [4.04 MB]
AriaMx Real-Time PCR System_CZ
pdf, [2.17 MB]
AriaMx Real-Time PCR System_EN
pdf, [2.14 MB]
CFX 96/Connect/Dx Real-Time PCR Detection System_CZ
pdf, [2.37 MB]
CFX 96/Connect/Dx Real-Time PCR Detection System_EN
pdf, [2.2 MB]
croBEE Real-Time PCR System_CZ
pdf, [6.09 MB]
croBEE Real-Time PCR System_EN
pdf, [5.9 MB]
LightCycler 2.0_CZ
pdf, [1.85 MB]
LightCycler 2.0_EN
pdf, [1.94 MB]
LightCycler 480/480 Instrument II_CZ
pdf, [2.3 MB]
LightCycler 480/480 Instrument II_EN
pdf, [2.18 MB]
LineGene 9600_9600Plus_K_CZ
pdf, [4.66 MB]
LineGene 9600_9600Plus_K_EN
pdf, [4.6 MB]
Mic qPCR Cycler_CZ
pdf, [2.7 MB]
Mic qPCR Cycler_EN
pdf, [2.6 MB]
QuantStudio 3/5 Real-Time PCR System_CZ
pdf, [2.31 MB]
QuantStudio 3/5 Real-Time PCR System_EN
pdf, [2.29 MB]
Rotor-Gene_3000_6000_Q_CZ
pdf, [2.25 MB]
Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]
SLAN Real-Time PCR System_CZ
pdf, [1.59 MB]
SLAN Real-Time PCR System_EN
pdf, [1.56 MB]
StepOne/StepOne Plus Real-Time PCR System_CZ
pdf, [4.37 MB]
StepOne/StepOne Plus Real-Time PCR System_EN
pdf, [4.42 MB]

Product Leaflet

GP_GPacks_Product_Leaflet_EN.pdf
pdf, [254.55 kB]
GP_HBV_Leaflet_EN
pdf, [134.48 kB]
Files are available only for registered users.

Order

+420 543 211 679
sales@geneproof.com


Technical Support 

Contact form 
+420 730 176 222
support@geneproof.com


FAQ

 

 

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