GeneProof Varicella-Zoster Virus (VZV) PCR Kit
CE IVD
PRODUCT DETAIL
The PCR kit is designed for detection of Varicella-zoster virus (VZV) by the real-time Polymerase Chain Reaction (PCR) method.
The VZV detection consists in amplification of a specific conservative DNA sequence of the single copy gene ORF62 and in measurement of fluorescence increase. The VZV presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative and quantitative detection.
TECHNICAL SPECIFICATION
Technology | real-time PCR |
Type of Analysis | qualitative and quantitative |
Target Sequence | a specific conservative DNA sequence of the single-copy gene ORF62 |
Specificity | Varicella-zoster virus (VZV), 100% |
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) |
Linear Range | 1010 – 102 cp/ml with precision of ± 0.8 log |
Reporting Units | cp/µl |
Metrological Traceability | AcroMetrix™ VZV High Plasma Control (cat. n. 954514) |
Extraction/Inhibition Control | PCR inhibition control (ISIN version)
PCR inhibition and DNA extraction efficiency control (ISEX version) |
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 |
Validated 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 PlusMic 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 |
Quality Control | Quality management system is certified in compliance with the requirements of the standard ISO 13485 |
External Quality Assessment | regularly tested by QCMD and Instand e.V. External Quality Assessment Panels - results at www.geneproof.com |
Certification | CE IVD for in vitro Diagnostic Use |
ORDER INFORMATION
Product name | Cat. No. | Technology | Package |
GeneProof Varicella-Zoster Virus (VZV) PCR Kit | VZV/ISIN/025 | real-time PCR | 25 reactions |
GeneProof Varicella-Zoster Virus (VZV) PCR Kit | VZV/ISIN/050 | real-time PCR | 50 reactions |
GeneProof Varicella-Zoster Virus (VZV) PCR Kit | VZV/ISIN/100 | real-time PCR | 100 reactions |
GeneProof Varicella-Zoster Virus (VZV) PCR Kit | VZV/ISEX/025 | real-time PCR | 25 reactions |
GeneProof Varicella-Zoster Virus (VZV) PCR Kit | VZV/ISEX/050 | real-time PCR | 50 reactions |
GeneProof Varicella-Zoster Virus (VZV) PCR Kit | VZV/ISEX/100 | real-time PCR | 100 reactions |