GeneProof Hepatitis C Virus (HCV) Diagnostic 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 is based on the amplification of a single-copy 5' UTR RNA sequence and the measurement of fluorescence increase. The mechanism of duplex targeting ensures maximum sensitivity and specificity and enables detection of the virus in a sample before seroconversion. The specificity was tested to all six identified virus genotypes including the in-silico analysis proving the correct detection of a newly discovered genotype 7. The presence of HCV is indicated by the increased FAM fluorophore fluorescence. An Internal Standard (IS), which is a part of the PCR kit, is used as a control for the whole diagnostic process, i.e. RNA extraction efficiency, reverse-transcription step efficiency (transcription of RNA into cDNA) and PCR amplification efficiency (PCR inhibition). The IS positive amplification is detected in the HEX fluorophore fluorescence channel. The PCR kit is designed for in vitro diagnostics for both qualitative and quantitative detection and it utilizes the "hot start" technology minimizing non-specific reactions and ensuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG) which eliminates possible contamination of the PCR with amplification products.
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TECHNICAL SPECIFICATION
| Technology | One-Step RT real-time PCR |
| Target Analysis | qualitative and quantitative |
| Target Sequence | conservative region of 5' UTR sequence |
| Analytical Specificity | HCV genotype 1–7, 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 170.491 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) |
| Diagnostic Specificity | 100 % (CI95% : 99.07% - 100%) |
| Diagnostic Sensitivity | 100 % (CI95% : 95.39% - 100%) |
| Linear Range | 109 – 102 IU/ml with precision of ± 0.5 log (using manual extraction GeneProof PathogenFree RNA Isolation Kit) 109 – 170.491 IU/ml with precision of ± 0.5 log (using automatic extractor croBEE NA16 Nucleic Acid Extraction System) 109 – 101.7 IU/ml with precision of ± 0.5 log (using automatic extractor MagCore Automated NA Extractor) |
| Dynamic Range | 109 – 53.505 IU/ml (using manual extraction GeneProof PathogenFree RNA Isolation Kit) 109 – 170.491 IU/ml (using automatic extractor croBEE NA16 Nucleic Acid Extraction System) 109 – 33.473 IU/ml (using automatic extractor MagCore Automated NA Extractor) |
| Reporting Units | IU/μl |
| Conversion Factor | 1 IU = 1 cp |
| Metrological Traceability | HCV NIBSC 14/150 |
| Extraction/Inhibition Control | PCR inhibition and RNA extraction efficiency control (ISEX version) |
| Validated Specimen | plasma, 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 LightCycler® 480 Mic qPCR Cycler Rotor-Gene 3000 / 6000 / Q |
| Required Detection Channels | FAM, HEX |
| External Quality Assessment | Regularly tested by QCMD and INSTAND e.V. External Quality Assessment panels - results at www.geneproof.com |
| Regulatory Status |
CE1023 IVD |
* Validated Instruments
ORDER INFORMATION
| Product name | Cat. No. | Technology | Package |