GeneProof Hepatitis C Virus (HCV) PCR Kit

CE₁₀₂₃ IVD

PRODUCT DETAIL

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.

TECHNICAL SPECIFICATION 

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
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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 

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