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GeneProof® BK Virus (BKV) PCR Kit
| Manufacturer: | GeneProof |
|---|---|
| Country: | Czech Republic |
Specialist consultation
+38 (067) 880 44 83Details
W.H.O. STANDARD BASED QUANTIFICATION
Precise and fully traceable quantification according to 1st WHO International Standard NIBSC BKV 14/212
Enables reliable viral load monitoring
EASY-TO-USE CONCEPT
Single tube Ready-to-Use Master Mix contains all components for PCR amplification
No additional PCR reagents pipetting necessary
SIMPLE LABORATORY WORKFLOW
Easily combinable with other GeneProof PCR kits in one workflow
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
BKV/GP/025 - 25 tests
BKV/GP/100 - 100 tests
Characteristics
| INDICATION | in vitro diagnostic medical device |
|---|---|
| TECHNOLOGY | real-time PCR |
| TARGET SEQUENCE | T-Ag gene encoding large tumor antigen |
| DIAGNOSTIC SPECIFICITY | 100.00 % (CI95%: 86.27 % – 100.00 %) |
| POSITIVE PREDICTIVE VALUE | 100.00 % (CI95%: 83.98 % – 100.00 %) |
| LINEAR RANGE | 10*10 – 10*3 IU/ml with precision of ± 0.5 log (using manual or automatic extraction from plasma, CSF and whole blood) |
| REPORTING UNITS | IU/ml |
| METROLOGICAL TRACEABILITY | 1st WHO International Standard for BK virus DNA (NIBSC code 14/212) |
| VALIDATED SPECIMEN | CSF, plasma, urine, whole blood |
| VALIDATED EXTRACTION METHOD | ▪ croBEE 201A Nucleic Acid Extraction Kit ▪ GeneProof PathogenFree DNA Isolation Kit |
| REQUIRED DETECTION CHANNELS | FAM, HEX/JOE |
| REGULATORY STATUS | CE IVD |
|---|---|
| TYPE OF ANALYSIS | qualitative and quantitative |
| ANALYTICAL SPECIFICITY | BK virus (BKV), 100 % |
| DIAGNOSTIC SENSITIVITY | 96.30 % (CI95%: 79.11 % – 99.81 %) |
| NEGATIVE PREDICTIVE VALUE | 96.88 % (CI95%: 82.00 % – 99.84 %) |
| DYNAMIC RANGE | 10*10 – LoD IU/ml (LoD varying according to the extraction and material used) |
| CONVERSION FACTOR | 1 IU = 1 cp |
| EXTRACTION/INHIBITION CONTROL | PCR inhibition and DNA extraction efficiency control by Internal Control |
| STORAGE | -20 ± 5 °C |
| INSTRUMENTS | ▪ croBEE Real-Time PCR System ▪ Applied Biosystems 7300 / 7500 Real-Time PCR System ▪ AriaMx Real-Time PCR System ▪ CFX Connect / CFX96/ Dx Real-Time PCR Detection System ▪ LineGene 9600 Plus ▪ Rotor-Gene 3000 / Q ▪ SLAN® 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
| Contact phone | +38 (067) 133 05 52 |
|---|---|
| E-mail: | service@empirica.healthcare |
