GeneProof Varicella-Zoster Virus (VZV) PCR Kit
Kat.: VZV/ISEX/025
A termék CE/IVD minősítéssel rendelkezik és az OGYÉI által nyilvántartásba vett.
A Varicella-zoster (VZV) virus detektálására alkalmas ‘Ready-to-Use ‘ master mix. A ORF62-t kódoló gén specifikus, egyetlen kópiájú, konzervatív DNS szekvenciát célozza. (25 reakció)
Leírás
PRODUCT ADVANTAGES
EXCELLENT EQA PANEL RESULTS
- The highest possible diagnostic sensitivity (100.00 %) and diagnostic specificity (96.97 %) confirmed by analysis of EQA panel reports from 2009 to present (including infrequently detected rare samples with very low concentrations)
UNIVERSAL PCR PROFILE
- Easily combinable with other PCR kits from the Immunocompromised / Transplanted and Neuroinfections groups
- Simplifies laboratory workflow
QUALITATIVE AND QUANTITATIVE DETECTION
- Quantification of viral load provides additional information for the management of VZV infection
CONTAMINATION ELIMINATION
- Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible contamination
COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES
CE IVD CERTIFIED DIAGNOSTIC TEST
Technical specification
| Indication | in vitro diagnostic medical device |
| Intended User | For professional use in laboratories with trained staff |
| Technology | real-time PCR |
| Type of Analysis | qualitative and quantitative |
| Target Sequence | a specific conservative DNA sequence of the single-copy gene ORF62 |
| Analytical Specificity | Varicella-zoster virus (VZV), 100% |
| Analytical Sensitivity (LoD) | reaches up to 113.05 cp/ml with the probability of 95 % (on AcroMetrix™ VZV High Plasma Control using manual extraction GeneProof PathogenFree DNA Isolation Kit) |
| Diagnostic Specificity | 96.97% (CI95%: 82.49% – 99.84%) |
| Diagnostic Sensitivity | 100% (CI95%: 96.50% – 100%) |
| Linear Range | 1010 – 113.05 cp/ml with precision of ± 0.8 log |
| Dynamic Range | 1010 – 113.05 cp/ml |
| Reporting Units | cp/µl |
| Metrological Traceability | AcroMetrix™ VZV High Plasma Control (cat. n. 954514) |
| Extraction/Inhibition Control | PCR inhibition and DNA extraction efficiency control |
| Validated Specimen | whole blood, plasma, serum, CSF |
| Storage | -20 ± 5 °C |
| Validated Extraction Method | croBEE NA16 Nucleic Acid Extraction System GeneProof PathogenFree DNA Isolation Kit |
| 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 LightCycler® 2.0 / 480 LineGene 9600 / 9600 Plus Mic qPCR Cycler QuantStudio™ 3 / 5 Real-Time PCR System Rotor-Gene 3000 / Q SLAN® Real-Time PCR System StepOne™ / StepOnePlus™ Real-Time PCR System |
| Required Detection Channels | FAM, HEX |
| External Quality Assessment | regularly tested by QCMD and Instand e.V. External Quality Assessment Panels – results at www.geneproof.com |
| Certification | CE IVD |
