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GeneProof® Human Herpesvirus 8 (HHV-8) PCR Kit
| Manufacturer: | GeneProof |
|---|---|
| Country: | Czech Republic |
Specialist consultation
+38 (067) 880 44 83Details
DUAL TARGET DETECTION
Dual targeting prevents a detection failure caused by the occurrence of mutations
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
QUALITATIVE AND QUANTITATIVE DETECTION
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
УНІВЕРСАЛЬНИЙ ПЛР-ПРОФІЛЬ = ОДИН РОБОЧИЙ ПРОЦЕС
СЕРТИФІКОВАНИЙ ДІАГНОСТИЧНИЙ ТЕСТ CE IVD
HHV8/GP/025 - tests
HHV8/GP/100 - tests
Characteristics
| INDICATION | in vitro diagnostic medical device |
|---|---|
| TECHNOLOGY | Real-time PCR |
| TARGET SEQUENCE | ORF26 gene, ORF73 gene |
| DIAGNOSTIC SPECIFICITY | 93.75 % (CI95%: 67.71 % – 99.67 %) |
| POSITIVE PREDICTIVE VALUE | 93.33 % (CI95%: 66.03 % – 99.65 %) |
| DYNAMIC RANGE | (10*9 – LoD) cp/ml (LoD varying according to the extraction and material used) |
| CONVERSION FACTOR | Not applicable |
| 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 ▪ QuantStudio 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 Instand e.V. External Quality Assessment Panels – results at www.geneproof.com |
| REGULATORY STATUS | CE 2797 IVD / Regulation (EU) 2017/746 |
|---|---|
| TYPE OF ANALYSIS | Qualitative and quantitative |
| ANALYTICAL SPECIFICITY | Human Herpesvirus 8 (HHV-8), 100% |
| DIAGNOSTIC SENSITIVITY | 100.00 % (CI95%: 73.24 % – 100.00 %) |
| NEGATIVE PREDICTIVE VALUE | 100.00 % (CI95%: 74.65 % – 100.00 %) |
| REPORTING UNITS | cp/ml |
| METROLOGICAL TRACEABILITY | Not applicable |
| VALIDATED SPECIMEN | DNA extracted from CSF, plasma, whole blood (EDTA), saliva (qualitative detection only) |
| VALIDATED EXTRACTION METHODS | ▪ croBEE 201A Nucleic Acid Extraction Kit ▪ myCROBE/croBEE 2.0 Universal Extraction Kit ▪ GeneProof PathogenFree DNA Isolation Kit |
| DETECTION CHANNELS | FAM (HHV-8), HEX/JOE/VIC (IC) |
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 |
