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GeneProof Hepatitis C Virus (HCV) PCR Kit

CE 1023 IVD 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

CE IVD CERTIFIED DIAGNOSTIC TEST

 

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

Order information

Product name Catalog no. Technology Packaging
GeneProof Hepatitis C Virus (HCV) PCR Kit

EQA Panels

EQA results

GP_HCVD_QCMD_2020
pdf, [192.74 kB]
GP_HCV_QCMD_EN
pdf, [167.06 kB]
GP_Instand_03.2019_EN
pdf, [327.24 kB]
Choose all

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 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 available on related product page 
Certification CE1023 IVD for in vitro Diagnostic Use 

Documentation

Instruction for Use

GP_HCV_Instruction for Use_EN
pdf, [367.94 kB]

Declaration of Conformity

GP_FQAS EC Certificate_EN
pdf, [48.26 kB]
GP_HCV_Declaration of Conformity_EN
pdf, [298 kB]

MSDS

GP_HCV_PCR_Kit_Safety Data Sheet_PCR Kit_EN
pdf, [140.74 kB]

Manual

croBEE Real-Time PCR System_EN
pdf, [5.9 MB]
Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]

PCR Template

GP_HCV_Mic_1
micassay, [13.09 kB]
Files are available only for registered users.

Order

+420 543 211 679
sales@geneproof.com


Technical Support 

Send request
+420 730 176 222
support@geneproof.com


FAQ


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