GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit

CE1023 IVD

PRODUCT ADVANTAGES

UNIQUE DUAL TARGET DETECTION

  • Prevents analysis failure caused by the appearance of mutants
  • Ensures maximum sensitivity, reaches up to 7.95 IU/ml
  • Ensures maximum specificity

CONTAMINATION ELIMINATION

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

INTERNAL RNA CONTROL

  • Controls the whole diagnostic process, i.e. efficiency
  • RNA extraction, reverse transcription and PCR amplification 
  • IC is included in the PCR kit

DETECTS THE NEWLY DESCRIBED GENOTYPES 7 AND 8

  • The Kit detects all known HCV genotypes 1–8

SINGLE TUBE READY-TO-USE MASTERMIX

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

TECHNICAL SPECIFICATION 

Technology real-time PCR
Target Analysis qualitative and quantitative 
Target Sequence conservative region of 5' UTR sequence
Analytical Specificity HCV genotype 1–8, 100 %
Analytical Sensitivity (LoD)

reaches up to 53.505 IU/ml with the probability of 95 % (on HCV NIBSC 14/150 using manual extraction GeneProof PathogenFree RNA Isolation Kit)
reaches up to 170.062 IU/ml with the probability of 95% (on HCV NIBSC 14/150 using automatic extractor croBEE NA16 Nucleic Acid Extraction System)
reaches up to 33.473 IU/ml with the probability of 95% (on Acrometrix HCV-S Panel using automatic extractor MagCore Automated NA Extractor)
reaches up to 7.95 IU/ml with the probability of 95 % (on Acrometrix HCV-S Panel using manual extraction SpinStar Viral Nucleic Acid Kit 1.0 with SpinStar Pretreatment Solution)

Diagnostic Specificity

100 % (CI95% : 99.07% - 100%)

Diagnostic Sensitivity

100 % (CI95% : 95.39% - 100%)

Linear Range 

108.5 – 102 IU/ml with precision of ± 0.5 log (using manual extraction GeneProof PathogenFree RNA Isolation Kit)
108.5 – 170.062 IU/ml with precision of ± 0.5 log (using automatic extractor croBEE NA16 Nucleic Acid Extraction System)
108.5 – 101.7 IU/ml with precision of ± 0.5 log (using automatic extractor MagCore Automated NA Extractor)

Dynamic Range 108.5 – 53.505 IU/ml (using manual extraction GeneProof PathogenFree RNA Isolation Kit)
108.5 – 170.491 IU/ml (using automatic extractor croBEE NA16 Nucleic Acid Extraction System)
108.5 – 33.473 IU/ml (using automatic extractor MagCore Automated NA Extractor)
Reporting Units IU/μl
Conversion Factor

Not applicable

Metrological Traceability HCV NIBSC 14/150
Extraction/Inhibition Control PCR inhibition and RNA extraction efficiency control (ISEX version)
Validated Specimen Plasma (EDTA), serum
Storage -20 ± 5 °C  
Validated Extraction Methods croBEE NA16 Nucleic Acid Extraction System
GeneProof PathogenFree RNA Isolation Kit
MagCore Automated NA Extractor
Instruments croBEE Real-Time PCR System*
Applied Biosystems 7300 / 7500 Real-Time PCR System
CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System
LineGene 9600 Plus
Mic qPCR Cycler
Rotor-Gene 3000 / 6000 / Q
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
Regulatory Status
CE1023 IVD

* Validated Instruments

ORDER INFORMATION

Product name

Cat. No. Technology Package
GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit HCVD/ISEX/025 real-time PCR 25 reactions
GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit HCVD/ISEX/050 real-time PCR 50 reactions
GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit HCVD/ISEX/100 real-time PCR 100 reactions