GeneProof Varicella-Zoster Virus (VZV) PCR Kit

CE IVD

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 management of VZV infection

CONTAMINATION ELIMINATION

  • Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible contamination with amplification products

 

TECHNICAL SPECIFICATION

Technology

real-time PCR

Type of Analysis

qualitative and quantitative

Target Sequence

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 %)

Diagnsotic 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

Conversion Factor

not applicable

Metrological Traceability

 AcroMetrix™ VZV High Plasma Control (cat. n. 954514)

Extraction/Inhibition Control

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

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

* validated instrument

ORDER INFORMATION

Product name

Cat. No. Technology Package
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