GeneProof Hepatitis C Virus (HCV) PCR Kit

CE IVD

PRODUCT ON REQUEST

 

PRODUCT ADVANTAGES

DETECTS A BROAD SPECTRUM OF HCV GENOTYPES

  • The kit detects HCV genotypes 1 – 7

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

INTERNAL RNA CONTROL

  • Controls the whole diagnostic process
  • RNA extraction, reverse transcription and PCR amplification
  • IC is included in the PCR Kit

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES
CERTIFIED DIAGTNOSTIC TEST

Product on request. For more information contact your sales manager or sales@geneproof.com.

 

TECHNICAL SPECIFICATION

Technology real-time PCR
Target Analysis qualitative and quantitative 
Target Sequence conservative region of 5' UTR sequence
Analytical Specificity HCV genotype 1–7, 100 %
Analytical Sensitivity (LoD)

Reaches up to 7.87 IU/ml with the probability of 95% (on AcroMetrix
HCV High Control using automatic extraction MagCore NA Extractor)
Reaches up to 208.54 IU/ml with the probability of 95% (on AcroMetrix
HCV High Control using automatic extraction croBEE NA16 Nucleic Acid
Extraction System)
Reaches up to 213.965 IU/ml with the probability of 95% (on HCV NIBSC
14/150 using manual extraction GeneProof PathogenFree RNA Isolation
Kit)

Linear Range 

1010 - 25 IU/ml with precision of ± 0.5 log

Dynamic Range 1010 - 7.87 IU/ml
Reporting Units IU/μl (1 IU = 5.62 cp)
Validated Specimen Plasma, serum
Storage -20 ± 5 °C  
Validated Extraction Methods croBEE NA16 Nucleic Acid Extraction System
GeneProof PathogenFree RNA 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
Rotor-Gene 3000 / 6000 / Q
SLAN® 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
Regulatory Status
CE1023 IVD

* Validated Instruments

ORDER INFORMATION

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