GeneProof Hepatitis C Virus (HCV) PCR Kit

GeneProof Hepatitis C Virus (HCV) PCR Kit

CE1023 IVD


The PCR kit is designed for the Hepatitis C virus (HCV) RNA detection by the one-step RT real-time Polymerase Chain Reaction (PCR) method.

The HCV detection consists in amplification of a single-copy 5' UTR RNA sequence and in measurement of fluorescence increase. The HCV presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is included in the PCR kit, controlling the whole diagnostic process, i.e. RNA extraction efficiency, reverse-transcription step efficiency (transcription of RNA into cDNA) and PCR amplification efficiency (PCR inhibition). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. The kit is designed for in vitro diagnostics and provides qualitative and quantitative detections.


Technology One-Step RT real-time PCR
Target Analysis qualitative and quantitative
Target Sequence conservative region of 5' UTR sequence
Specificity HCV genotype 1–7, 100 %
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 208.544 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 logDynamic Range1010 - 7.78 IU/mlReporting UnitsIU/μlConversion Factor1 IU = 5.62 cpMetrological TraceabilityHCV NIBSC 14/150Extraction/Inhibition ControlPCR inhibition and RNA extraction efficiency controlValidated Specimenplasma, serumStorage-20 ± 5 °CValidated Extraction MethodscroBEE NA16 Nucleic Acid Extraction System
GeneProof PathogenFree RNA Isolation KitValidated InstrumentscroBEE 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

Mic qPCR Cycler

QuantStudioTM 3 / 5 Real-Time PCR System
Rotor-Gene 3000 / 6000 / Q

SLAN® Real-Time PCR SystemRequired Detection ChannelsFAM, HEXQuality Controlquality management system is certified in compliance with the requirements of the standard ISO 13485External Quality AssessmentRegularly tested by QCMD and INSTAND e.V. External Quality Assessment panels - results at www.geneproof.comCertificationCE1023 IVD for in vitro Diagnostic Use 



Product name Cat. No. Technology Package
GeneProof Hepatitis C Virus (HCV) PCR Kit HCV/PLUS/025 One-Step RT real-time PCR 25 reactions
GeneProof Hepatitis C Virus (HCV) PCR Kit HCV/PLUS/050 One-Step RT real-time PCR 50 reactions
GeneProof Hepatitis C Virus (HCV) PCR Kit HCV/PLUS/100 One-Step RT real-time PCR 100 reactions

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