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GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit

CE 1023 IVD New product

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 MASTER MIX

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

EQA Panels

EQA results

GP_HCVD_QCMD_C3.2018_EN
pdf, [165.27 kB]
GP_HCVD_QCMD_croBEE_2019_EN
pdf, [167 kB]
GP_HCVD_QCMD_manual_2019_EN
pdf, [167.03 kB]
GP_HCVplus_QCMD_2020_EN
pdf, [192.63 kB]
GP_Instand_03.2019_EN
pdf, [327.24 kB]
Choose all

Technical specification

Technology One-Step 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  

1100 % (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 – 170.062 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

Non aplicable

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

*Validated instruments

 

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.45 MB]
GP_HCVD_Advisory Notice_EN_CZ
pdf, [211.3 kB]
GP_HCVD_Instruction for Use_EN
pdf, [105.71 kB]

Declaration of Conformity

GP_FQAS EC Certificate_EN
pdf, [48.26 kB]
GP_HCVD_Declaration of conformity_EN
pdf, [339.96 kB]
GP_HCVD_EC Design Examination Certificate_EN
pdf, [336.18 kB]

MSDS

GP_HCVD_Safety Data Sheet_EN
pdf, [801.43 kB]

Manual

Bio-Rad CFX 96/Connect/Dx Real-Time PCR Detection System_EN
pdf, [1.43 MB]
croBEE Real-Time PCR System_EN
pdf, [5.9 MB]
Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]

Product Leaflet

GP_HCVD_Leaflet_EN
pdf, [185.8 kB]

PCR Template

GP_HCVD_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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