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GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit

CE 1023 IVD

PRODUCT ADVANTAGES

 

RELIABLE DIAGNOSTICS

  • Dual targeting prevents detection failures caused by the occurrence of mutations
  • 100% diagnostic sensitivity

HIGH SPECIFICTIY

  • The kit detects all known HCV genotypes 1-8
  • 100% diagnostic specificity

UNIQUE FALSE-NEGATIVE RESULTS CONTROL

  • Unique Internal RNA control construction
  • Controls the whole diagnostic process, including RNA extraction, reverse transcription, and PCR amplification

W.H.O. STANDARD BASED QUANTIFICATION

  • Precise and fully traceable quantification according to 4th WHO International Standard NIBSC 10/266

EASY-TO-USE CONCEPT

  • Single tube Ready-to-Use Master Mix contains all components for PCR amplification
  • No additional PCR reagents pipetting necessary

CONTAMINATION PREVENTION

  • Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating carryover contamination

 

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE1023IVD 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_22_EN
pdf, [1.06 MB]
; 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
Regulatory Status CE1023 IVD
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 with 95% probability)

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/ml
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 in QCMD and INSTAND e.V. External Quality Assessment panels - results available at www.geneproof.com  

Documentation

Instruction for Use

; Declaration of Verification of the kits with medical devices
pdf, [1.61 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, [607.1 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, [147.37 kB]

Manual

; Bio-Rad CFX 96/Connect/Dx Real-Time PCR Detection System_EN
pdf, [1.43 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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