GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit
CE1023 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
- 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 MASTERMIX
- Contains all components for PCR amplification
- No additional PCR reagents pipetting necessary
- Reduces the need for qualified laboratory staff
- Ensures reproducibility of the results
TECHNICAL SPECIFICATION
| 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) |
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) |
| 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 (using manual extraction GeneProof PathogenFree RNA Isolation Kit) |
| Dynamic Range | 108.5 – 53.505 IU/ml (using manual extraction GeneProof PathogenFree RNA Isolation Kit) 108.5 – 170.491 IU/ml (using automatic extractor croBEE NA16 Nucleic Acid Extraction System) 108.5 – 33.473 IU/ml (using automatic extractor MagCore Automated NA Extractor) |
| Reporting Units | IU/μl |
| Conversion Factor |
Not applicable |
| Metrological Traceability | HCV NIBSC 14/150 |
| Extraction/Inhibition Control | PCR inhibition and RNA extraction efficiency control (ISEX version) |
| Validated Specimen | Plasma (EDTA), 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 LineGene 9600 Plus 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 |
| 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/050 | real-time PCR | 50 reactions |
| GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit | HCVD/ISEX/100 | real-time PCR | 100 reactions |