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GeneProof® Hepatitis C Virus (HCV) Diagnostic PCR Kit
| Manufacturer: | GeneProof |
|---|---|
| Country: | Czech Republic |
Specialist consultation
+38 (067) 880 44 83Details
RELIABLE DIAGNOSTICS
• Dual targeting prevents detection failures caused by the occurrence of mutations
• 100% diagnostic sensitivity
HIGH SPECIFICTIY
• The kit detects all known HCV genotypes 1-8
• 100% diagnostic specificity
UNIQUE FALSE-NEGATIVE RESULTS CONTROL
• Unique Internal RNA control construction
• Controls the whole diagnostic process, including RNA extraction, reverse transcription, and PCR amplification
W.H.O. STANDARD BASED QUANTIFICATION
• Precise and fully traceable quantification according to 5th WHO International Standard NIBSC 14/150
EASY-TO-USE CONCEPT
• Single tube Ready-to-Use Master Mix contains all components for PCR amplification
• No additional PCR reagents pipetting necessary
CONTAMINATION PREVENTION
• Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating carryover contamination
COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES
CE IVD CERTIFIED DIAGNOSTIC TEST
HCVD/ISEX/025 – 25 tests
HCVD/ISEX/100 – 100 tests
Characteristics
| INDICATION | in vitro diagnostic medical device |
|---|---|
| INTENDED USER | For professional use in laboratories with trained staf |
| TYPE OF ANALYSIS | Qualitative and quantitative |
| ANALYTICAL SPECIFICITY | HCV genotype 1–8, 100 % |
| DIAGNOSTIC SPECIFICITY | 100.00 % (CI95% : 99.07 % – 100.00 %) |
| LINEAR RANGE | 10*8.5 – 10*2 IU/ml with precision of ± 0.5 log (GeneProof PathogenFree RNA Isolation Kit); 10*8.5 – 170.062 IU/ml with precision of ± 0.5 log (croBEE 201A Nucleic Acid Extraction System); 10*8.5 – 10*1.7 IU/ml with precision of ± 0.5 log (MagCore Automated NA Extractor) |
| REPORTING UNITS | IU/ml |
| VALIDATED SPECIMEN | Plasma (EDTA, citrate), serum |
| VALIDATED EXTRACTION METHOD | croBEE 201A Nucleic Acid Extraction System; GeneProof PathogenFree RNA Isolation Kit; MagCore Automated NA Extractor |
| REQUIRED DETECTION CHANNELS | FAM, HEX |
| EXTERNAL QUALITY ASSESSMENT | Regularly tested in QCMD and Instand e.V. External Quality Assessment Panels – results at www.geneproof.com |
| REGULATORY STATUS | CE IVD |
|---|---|
| TECHNOLOGY | Real-time PCR |
| TARGET SEQUENCE | Conservative region of 5‘ UTR sequence |
| ANALYTICAL SENSITIVITY (LoD with probability 95 %) | 53.505 IU/ml (on HCV NIBSC 14/150 using GeneProof PathogenFree RNA Isolation Kit); 170.062 IU/ml (on HCV NIBSC 14/150 using croBEE 201A Nucleic Acid Extraction Kit); 33.473 IU/ml (on Acrometrix HCV-S Panel using MagCore Automated NA Extractor); 7.95 IU/ml (on Acrometrix HCV-S Panel using SpinStar Viral Nucleic Acid Kit 1.0 with SpinStar Pretreatment Solution) |
| DIAGNOSTIC SENSITIVITY | 100.00 % (CI95% : 95.39 % – 100.00 %) |
| DYNAMIC RANGE | 10*8.5 – 53.505 IU/ml (GeneProof PathogenFree RNA Isolation Kit); 10*8.5 – 170.062 IU/ml (croBEE 201A Nucleic Acid Extraction System); 10*8.5 – 33.473 IU/ml (MagCore Automated NA Extractor) |
| METROLOGICAL TRACEABILITY | HCV NIBSC 14/150 |
| STORAGE | -20 ± 5 °C |
| INSTRUMENTS | croBEE Real-Time PCR System; Applied Biosystems 7300 / 7500 Real-Time PCR System; AMPLilab Real-Time PCR System; AriaMx Real-Time PCR System; BioQuant-96 Real-Time PCR System; CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System; Gentier 96E/96R Real-Time PCR System; LightCycler® 480 LineGene 9600 Plus; Mic qPCR Cycler; QuantStudio™ 3 / 5 Real-Time PCR System; Rotor-Gene 3000 / 6000 / Q |
| QUALITY CONTROL | Quality management system is certified in compliance with the requirements of the standard ISO 13485 |
Service and Warranty
GENEPROOF CALCULATOR
The on-line calculator was developed by GeneProof to simplify the evaluation of GeneProof quantitative PCR kits.
To access the online calculator, click the button below
If you have any questions, please contact our specialists on the CONTACTS page.
We provide premium service and maintenance for every device and consumable:
• Comprehensive maintenance of medical equipment
• Installations, commissioning
• Warranty and post-warranty service
• Instruction, training and consultations for your team
More details on the SERVICE page
Contacts for communication:
| Contact phone | +38 (067) 120 95 75 |
|---|---|
| E-mail: | service@empirica.healthcare |