GeneProof Hepatitis B Virus (HBV) PCR Kit

CE1023 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

SINGLE TUBE READY-TO-USE MASTERMIX

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

HIGH SENSITIVITY

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

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

  • Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible contamination with amplification products

 

 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 % : 95.90 % – 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 (1 IU = 4.84 cp)

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
External Quality Assessment regularly tested by QCMD and Instand e.V. External Quality Assessment Panels – results at www.geneproof.com
Certification CE1023 IVD for in vitro Diagnostic Use

* Validated instruments

ORDER INFORMATION

Product name

Cat. No. Technology Package
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