GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit
Kat.: HCVD/ISEX/025
A termék CE/IVD minősítéssel rendelkezik és az OGYÉI által nyilvántartásba vett.
Minden ismert HCV 1–8 genotípus detektálására alkalmas, ‘Ready-To-Use’ master mix. Az 5′ UTR konzervatív régió szekvenciát célozza. (25 reakció)
Leírás
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 of 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 MASTER MIX
- Contains all components for PCR amplification
- No additional PCR reagents pipetting necessary
- Reduces the need for qualified laboratory staff
- Ensures reproducibility of the results
COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES
CE IVD CERTIFIED DIAGNOSTIC TEST
Technical specification
| Indication | in vitro diagnostic medical device |
| Intended User | For professional use in laboratories with trained staff |
| Technology | One-Step 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) reaches up to 170.062 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) reaches up to 7.95 IU/ml with the probability of 95 % (on Acrometrix HCV-S Panel using manual extraction 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 (using manual extraction GeneProof PathogenFree RNA Isolation Kit) 108.5 – 170.062 IU/ml with precision of ± 0.5 log (using automatic extractor croBEE NA16 Nucleic Acid Extraction System) 108.5 – 101.7 IU/ml with precision of ± 0.5 log (using automatic extractor MagCore Automated NA Extractor) |
| Dynamic Range | 108.5 – 53.505 IU/ml (using manual extraction GeneProof PathogenFree RNA Isolation Kit) 108.5 – 170.062 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 | Non aplicable |
| 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 |
| Quality Control | quality management system is certified in compliance with the requirements of the standard ISO 13485 |
| External Quality Assessment | Regularly tested by QCMD and INSTAND e.V. External Quality Assessment panels – results available at www.geneproof.com |
| Regulatory Status | CE1023 IVD |
