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GeneProof® Cytomegalovirus (CMV) PCR Kit
| Manufacturer: | GeneProof |
|---|---|
| Country: | Czech Republic |
Specialist consultation
+38 (067) 880 44 83Details
QUANTIFICATION BASED ON WHO STANDARDS
• Accurate and fully traceable quantification according to the 1st WHO International Standard NIBSC 09/162
SIMPLE LABORATORY WORKFLOW
• Easily combines with other GeneProof PCR kits in a single workflow
EASY-TO-USE CONCEPT
• Ready-to-use master mix in one tube contains all components for PCR amplification
• No need for additional pipetting of PCR reagents
PREVENTION OF CONTAMINATION
• The ready-to-use master mix contains uracil-DNA glycosylase (UNG) and dUTPs, which eliminates the possibility of contamination
COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES
CE IVD CERTIFIED DIAGNOSTIC TEST
CMV/ISEX/025 - 25 tests
CMV/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 | Human Cytomegalovirus (CMV), 100 % |
| DIAGNOSTIC SPECIFICITY | 90.67 % (CI95%: 81.15 % – 95.85 %) |
| LINEAR RANGE | 10*10 – 10*2.5 IU/ml with precision of ± 0.5 log |
| REPORTING UNITS | IU/ml |
| STORAGE | -20 ± 5 °C |
| REQUIRED DETECTION CHANNELS | FAM, HEX |
| REGULATORY STATUS | CE IVD |
|---|---|
| TECHNOLOGY | Real-time PCR |
| TARGET SEQUENCE | Specific conservative DNA sequence of a single copy gene encoding the 4 IE antigen |
| ANALYTICAL SENSITIVITY (LoD with the probability of 95 %) | 122.594 IU/ml (on CMV NIBSC 09/162, manual extraction GeneProof PathogenFree DNA Isolation Kit) 165.237 IU/ml (on CMV NIBSC 09/162, automatic extraction croBEE 201A Nucleic Acid Extraction Kit) |
| DIAGNOSTIC SENSITIVITY | 92.86 % (CI95%: 64.17 % – 99.63 %) |
| DYNAMIC RANGE | 10*10 – 122.594 cp/ml (using manual extraction GeneProof PathogenFree DNA Isolation Kit) 10*10 – 165.237 cp/ml (using automatic extraction croBEE 201A Nucleic Acid Extraction Kit) |
| VALIDATED SPECIMEN | plasma, serum, urine, whole blood |
| 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 Systems LightCycler® 2.0 / 480 LineGene 9600 / 9600 Plus Mic qPCR Cycler QuantStudio™ 3 Real-Time PCR System Rotor-Gene 3000 / 6000 / Q SLAN® Real-Time PCR System StepOne™ / StepOnePlus™ 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 |