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GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit

CE 1023 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 of 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/100 real-time PCR 100 reactions

EQA Panels

EQA results

GP_HCVD_Instand_03_21_EN
pdf, [1.02 MB]
GP_HCVD_QCMD_2020
pdf, [192.74 kB]
GP_HCVD_QCMD_manual_2019_EN
pdf, [167.03 kB]
Choose all

Technical specification

Indication in vitro diagnostic medical device
Intended User For professional use in laboratories with trained staff
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)

53.505 IU/ml (on HCV NIBSC 14/150 using GeneProof PathogenFree RNA Isolation Kit)
170.062 IU/ml (on HCV NIBSC 14/150 using croBEE 201A Nucleic Acid Extraction Kit)
33.473 IU/ml (on Acrometrix HCV-S Panel using MagCore Automated NA Extractor)
7.95 IU/ml (on Acrometrix HCV-S Panel using 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 (GeneProof PathogenFree RNA Isolation Kit)
108.5 – 170.062 IU/ml with precision of ± 0.5 log (croBEE 201A Nucleic Acid Extraction System)
108.5 – 101.7 IU/ml with precision of ± 0.5 log (MagCore Automated NA Extractor)
Dynamic Range  108.5 – 53.505 IU/ml (GeneProof PathogenFree RNA Isolation Kit)
108.5 – 170.062 IU/ml (croBEE 201A Nucleic Acid Extraction System)
108.5 – 33.473 IU/ml (MagCore Automated NA Extractor)
Reporting Units IU/μl
Metrological Traceability HCV NIBSC 14/150
Extraction/Inhibition Control PCR inhibition and RNA extraction efficiency control (ISEX version)
Validated Specimen plasma (EDTA, citrate), serum
Storage -20 ± 5 °C  
Validated Extraction Methods

croBEE 201A 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
AMPLilab Real-Time PCR System
AriaMx Real-Time PCR System
BioQuant-96 Real-Time PCR System
CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System
LightCycler® 480
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 at www.geneproof.com  
Regulatory Status CE1023 IVD 

 

 

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.55 MB]
GP_HCVD_Advisory_Notice_05_22_EN
pdf, [550.66 kB]
GP_HCVD_Instruction_for_Use_EN
pdf, [231.23 kB]
GP_HCVD_Instruction_for_Use_ES
pdf, [207.9 kB]
GP_HCVD_Instruction_for_Use_FR
pdf, [242.68 kB]

Declaration of Conformity

GP_EC_Full_Quality_Assurance_Certificate_EN
pdf, [417.58 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, [278.39 kB]

PCR Template

GP_HCVD_Mic
micassay, [13.09 kB]
GP_HCVD_template_AmpliLAB
tlpi, [3.04 kB]
GP_UNI_3CH_2CH_ABI7500
edt, [10.33 kB]
GP_UNI_3CH_2CH_AriaMx
amxt, [3.64 kB]
GP_UNI_3CH_2CH_CroBee
fqt, [4.9 kB]
GP_UNI_BioRad
prcl, [1.33 kB]
RG_UNI_2CH_3CH_4CH
ret, [13.83 kB]

Product Leaflet

GP_HCVD_Leaflet_EN
pdf, [185.8 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]
Mic qPCR Cycler_EN
pdf, [2.33 MB]
Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]
Files are available only for registered users.

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