GeneProof Varicella-Zoster Virus (VZV) PCR Kit

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

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