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GeneProof® Hepatitis B Virus (HBV) PCR Kit
| Manufacturer: | GeneProof |
|---|---|
| Country: | Czech Republic |
Specialist consultation
+38 (067) 880 44 83Details
HIGH SPECIFICITY
• Secured by targeting specific conservative DNA sequence of P gene
• Prevents detection failure caused by the occurrence of mutations (including safe detection of core and pre-core mutants)
• Detection of all HBV genotypes A – H
• 100% diagnostic specificity
HIGH SENSITIVITY
• Ensures excellent sensitivity up to 13.9 IU/ml
• 100% diagnostic sensitivity
W.H.O. STANDARD BASED QUANTIFICATION
• Precise and fully traceable quantification according to 4th WHO International Standard NIBSC 10/266
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
HBV/ISEX/025 - 25 tests
HBV/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 | HBV genotype A-H, precore mutants HBV (HBeAg negative), 100 % |
| DIAGNOSTIC SPECIFICITY | 100.00 % (CI95%: 99.06 % – 100.00 %) |
| LINEAR RANGE | 10*10 – 10*2 IU/ml with precision of ± 0.5 log |
| REPORTING UNITS | IU/ml |
| VALIDATED SPECIMEN | Plasma, serum |
| VALIDATED EXTRACTION METHOD | croBEE 201A Nucleic Acid Extraction Kit GeneProof PathogenFree DNA Isolation Kit |
| REQUIRED DETECTION CHANNELS | FAM, HEX |
| REGULATORY STATUS | CE IVD |
|---|---|
| TECHNOLOGY | Real-time PCR |
| TARGET SEQUENCE | Specific conservative DNA sequence of P gene |
| ANALYTICAL SENSITIVITY (LoD with probability 95 %) | 36.9792 IU/ml (on HBV NIBSC 05/148 using GeneProof PathogenFree DNA Isolation Kit), 64.067 IU/ml (on HBV NIBSC 10/266 using croBEE 201A Nucleic Acid Extraction Kit), 13.9 IU/ml (on HBV NIBSC 10/266 using manual extraction SpinStar Viral Nucleic Acid Kit 1.0 with SpinStar Pretreatment Solution) |
| DIAGNOSTIC SENSITIVITY | 100.00 % (CI95%: 95.90 % – 100.00 %) |
| DYNAMIC RANGE | 10*10 – 36.9792 IU/ml (using GeneProof PathogenFree DNA Isolation Kit): 10*10 – 64.067 IU/ml (using croBEE 201A Nucleic Acid Extraction Kit) |
| METROLOGICAL TRACEABILITY | HBV NIBSC 10/266 (4th WHO International Standard) |
| STORAGE | -20 ± 5 °C |
| INSTRUMENTS | croBEE Real-Time PCR System; AMPLilab Real-Time PCR System; Applied Biosystems 7300 / 7500 Real-Time PCR System; AriaMx Real-Time PCR System; BioQuant-96 Real-Time PCR System; CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System; DT lite Real-Time PCR System; Gentier 96E/96R Real-Time PCR System; LightCycler® 2.0 / 480; LineGene 9600 / 9600 Plus; Mic qPCR Cycler; QuantStudioTM 3 / 5 Real-Time PCR System; Rotor-Gene 3000 / 6000 / Q; SLAN® Real-Time PCR System; StepOneTM/StepOne PlusTM Real-Time PCR System |
| EXTERNAL QUALITY ASSESSMENT | Regularly tested in QCMD and Instand e.V. External Quality Assessment Panels – results at www.geneproof.com |
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 |