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GeneProof® Parvovirus B19 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 WHO International Standard NIBSC 12/208
Enables reliable viral load monitoring
SIMPLE LABORATORY WORKFLOW
Easily combinable with other GeneProof PCR kits in one run
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
B19/ISEX/025 - 25 tests
B19/ISEX/100 - 100 tests
Characteristics
| INDICATION | in vitro diagnostic medical device |
|---|---|
| TEST PRINCIPLE | Real-time polymerase chain reaction (PCR) – amplification of the specific Target Sequence and detection using TaqMan probes with fluorophore-based detection |
| TARGET SEQUENCE | Gene encoding VP1 protein (capsid protein) |
| DIAGNOSTIC SPECIFICITY | 100.00 % (CI95%: 90.40 % – 100.00 %) |
| POSITIVE PREDICTIVE VALUE | 100.00 % (CI95%: 90.77 % – 100.00 %) |
| EXTRACTION/INHIBITION CONTROL | PCR inhibition and DNA extraction efficiency control by Internal Control (IC) |
| CONVERSION FACTOR | IU = 1 cp |
| VALIDATED SPECIMEN | Plasma, whole blood (EDTA) |
| VALIDATED EXTRACTION METHODS | ▪ croBEE 201A Nucleic Acid Extraction Kit ▪ GeneProof PathogenFree DNA Isolation Kit |
| REQUIRED DETECTION CHANNELS | FAM (B19), HEX/JOE/VIC (IS) |
| REGULATORY STATUS | CE IVD |
|---|---|
| TYPE OF ANALYSIS | Qualitative and quantitative |
| ANALYTICAL SPECIFICITY | Parvovirus B19, 100% |
| DIAGNOSTIC SENSITIVITY | 100.00 % (CI95%: 90.77 % – 100.00 %) |
| NEGATIVE PREDICTIVE VALUE | 100.00 % (CI95%: 90.40 % – 100.00 %) |
| REPORTING UNITS | IU/ml |
| METROLOGICAL TRACEABILITY | Parvovirus B19 NIBSC 12/208 |
| STORAGE | -20 ± 5 °C |
| INSTRUMENTS | ▪ croBEE Real-Time PCR System ▪ AMPLilab Real-Time PCR System ▪ Applied Biosystems 7500 Real-Time PCR System ▪ AriaMx Real-Time PCR System ▪ BioQuant-96 Real-Time PCR System ▪ CFX96/ Dx Real-Time PCR Detection System ▪ CFX Opus 96 Real-Time PCR System ▪ Gentier 96E/96R Real-Time PCR System ▪ LightCycler® 480 ▪ LineGene 9600 / 9600 Plus ▪ Mic qPCR Cycler ▪ QuantStudi 5 Real-Time PCR System ▪ Rotor-Gene 3000 / Q ▪ SLAN® Real-Time PCR System ▪ StepOne / StepOne Plus 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 |
