GeneProof Epstein-Barr Virus (EBV) PCR Kit

 CE IVD

PRODUCT ADVANTAGES

 

EXCELLENT EQA PANEL RESULTS

  • The highest possible diagnostic sensitivity (100.00 %) and diagnostic specificity (100.00 %) confirmed by analysis of EQA panel reports from 2008 to present (including infrequently detected rare samples with very low concentrations)

UNIVERSAL PCR PROFILE

  • Easily combinable with other PCR kits from the Immunocompromised / Transplanted group
  • Simplifies laboratory workflow

FULL TRACEABLE SENSITIVITY AND QUANTIFICATION 

  • Sensitivity was established with WHO certified strain (WHO International Standard NIBSC 09/260)
  • Precise and fully traceable quantification according to NIBSC 09/260 

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

DNA sequence of the single copy gene encoding the nuclear antigen 1 (EBNA1) 

Analytical Specificity

Epstein-Barr virus, 100 %

Analytical Sensitivity (LoD)

reaches up to 196.088 IU/ml with the probability of 95 % (on NIBSC EBV 09/260 using manual extraction GeneProof PathogenFree DNA Isolation Kit)

reaches up to 289.46 IU/ml with the probability of 95 % (on NIBSC EBV 09/260 using automatic extraction croBEE NA16 Nucleic Acid Extraction System)

Diagnostic Specifity

100 % (CI95 % : 83.98 % – 100 %) according to EQA panels results
90.91 % (CI95 % : 79.29 % – 96.60 %) according to Clinical performance analysis 2019

Diagnostic Sensitivity

100 % (CI95 % : 96.53 % – 100 %) according to EQA panels results
98.08 % (CI95 % : 88.42 % – 99.90 %) according to Clinical performance analysis 2019

Linear Range

1010 – 102.5 IU/ml with precision of ± 0.5 log (using manual extraction GeneProof PathogenFree DNA Isolation Kit)
1010 – 102.46 IU/ml with precision of ± 0.5 log (using automatic extraction croBEE NA16 Nucleic Acid Extraction
System)

Dynamic Range

1010 – 196.088 IU/ml (using manual extraction GeneProof PathogenFree DNA Isolation Kit)
1010 – 289.46 IU/ml (using automatic extraction croBEE NA16 Nucleic Acid Extraction System)

Reporting Units

cp/μl

Conversion Factor

1 IU = 1 cp

Metrological Traceability

EBV NIBSC 09/260

Extraction / Inhibition Control

PCR inhibition and DNA extraction efficiency control (ISEX version)

Validated Specimen CSF, plasma, whole blood, BAL
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 an www.geneproof.com
Regulatory Status CE IVD for in vitro Diagnostics Use

* Validated Instruments

ORDER INFORMATION

Product name

Cat. No. Technology Package
GeneProof Epstein-Barr Virus (EBV) PCR Kit EBV/ISEX/025 real-time PCR 25 reactions
GeneProof Epstein-Barr Virus (EBV) PCR Kit EBV/ISEX/050 real-time PCR 50 reactions
GeneProof Epstein-Barr Virus (EBV) PCR Kit EBV/ISEX/100 real-time PCR 100 reactions