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GeneProof® Human Herpesvirus 6/7 (HHV-6/7) PCR Kit
| Manufacturer: | GeneProof |
|---|---|
| Country: | Czech Republic |
Specialist consultation
+38 (067) 880 44 83Details
MORE INFORMATION WITH LESS SAMPLES PCR
Kit detects both viruses in a single reaction tube
QUANTITATIVE DETECTION OF BOTH VIRUSES
Precise quantification of both viruses in two separate detection channels
SIMPLE LABORATORY WORKFLOW
Easily combinable with other GeneProof PCR kits in one workflow
HIGH SENSITIVITY AND TRACEABILITY
Sensitivity was established with WHO certified strain
CONTAMINATION PREVENTION
Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating carryover contamination
UNIVERSAL PCR PROFILE = ONE WORKFLOW
CE IVD CERTIFIED DIAGNOSTIC TEST
HHV/ISEX/025 - 25 tests
HHV/ISEX/100 - 100 tests
Characteristics
| INDICATION | in vitro diagnostic medical device |
|---|---|
| TECHNOLOGY | Real-time PCR |
| TARGET SEQUENCE | U94 gene (HHV-6A/B), U57 gene (HHV-7) |
| DIAGNOSTIC SPECIFICITY | 96.08 % (CI95%: 89.69 % – 98.74 %) |
| POSITIVE PREDICTIVE VALUE | 98.65 % (CI95%: 96.34 % – 99.57 %) |
| DYNAMIC RANGE | 10*8 – LoD IU/ml (LoD varying according to the extraction and material used) |
| CONVERSION FACTOR | 1 IU = 0.6 cp (FAM), 1 cp = 1.8 IU (FAM), 1 cp = 1 IU (Cy5) |
| EXTRACTION/INHIBITION CONTROL | PCR inhibition and DNA extraction efficiency control by Internal Control (IC) |
| STORAGE | (-20 ± 5) °C |
| APPLIED 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 ▪ uantStudio™ 5 Real-Time PCR System ▪ 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 |
| REGULATORY STATUS | CE IVD / Regulation (EU) 2017/746 |
|---|---|
| TYPE OF ANALYSIS | Qualitative and quantitative |
| ANALYTICAL SPECIFICITY | Herpes simplex virus type 6 (HSV-6), 100 %, Herpes simplex virus type 7 (HSV-7), 100 % |
| DIAGNOSTIC SENSITIVITY | 100 % (CI95%: 98.38 % – 100 %) |
| NEGATIVE PREDICTIVE VALUE | 100 % (CI95%: 95.30 % – 100 %) |
| REPORTING UNITS | IU/ml |
| METROLOGICAL TRACEABILITY | 1st WHO International Standard for HHV-6B virus DNA, NIBSC code: 15/266 |
| VALIDATED SPECIMEN | DNA extracted from CSF, plasma, whole blood (EDTA) |
| VALIDATED EXTRACTION METHOD | ▪ croBEE 201A Nucleic Acid Extraction Kit ▪ myCROBE/croBEE 2.0 Universal Extraction Kit ▪ GeneProof PathogenFree DNA Isolation Kit |
| DETECTION CHANNELS | FAM (HHV-6), HEX/JOE/VIC (IC), Cy5* (HHV-7) |
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
CALCULATOR
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 |
