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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

 

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE IVD CERTIFIED DIAGNOSTIC TEST

Order information

Product name Catalog no. Technology Packaging
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

EQA Panels

EQA results

GP_EBV_QCMD_2018_EN
pdf, [283.44 kB]
GP_EBV_QCMD_2019_EN
pdf, [241.95 kB]
GP_EBV_QCMD_C2.2019_EN
pdf, [232.26 kB]
GP_Instand_06.2019_EN
pdf, [340.8 kB]
Choose all

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 Specificity 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 Rnage 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

NIBSC EBV 09/260

Extraction / Inhibition Control

PCR inhibition and DNA extraction efficiency control

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
Certification CE IVD

*Validated instruments

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.4 MB]
GP_Declaration of Change_EN_CZ
pdf, [201.13 kB]
GP_EBV_Advisory Notice_EN_CZ
pdf, [191.37 kB]
GP_EBV_Instruction for Use_CZ
pdf, [1.02 MB]
GP_EBV_Instruction for Use_EN
pdf, [1.02 MB]

Declaration of Conformity

GP_EBV_Declaration of Conformity_CZ
pdf, [292.29 kB]
GP_EBV_Declaration of Conformity_EN
pdf, [310.62 kB]

MSDS

GP_Safety Data Sheet_CZ
pdf, [134.4 kB]
GP_Safety Data Sheet_EN
pdf, [148.84 kB]

Manual

Applied Biosystems 7300/7500 Real-Time PCR System (SW 1.x.x)_CZ
pdf, [2.13 MB]
Applied Biosystems 7300/7500 Real-Time PCR System (SW 1.x.x)_EN
pdf, [2.03 MB]
Applied Biosystems 7500/7500 Fast Real-Time PCR System (SW 2.x.x)_CZ
pdf, [3.97 MB]
Applied Biosystems 7500/7500 Fast Real-Time PCR System (SW 2.x.x)_EN
pdf, [4.04 MB]
AriaMx Real-Time PCR System_CZ
pdf, [2.17 MB]
AriaMx Real-Time PCR System_EN
pdf, [2.14 MB]
CFX 96/Connect/Dx Real-Time PCR Detection System_CZ
pdf, [2.37 MB]
CFX 96/Connect/Dx Real-Time PCR Detection System_EN
pdf, [2.2 MB]
croBEE Real-Time PCR System_CZ
pdf, [6.09 MB]
croBEE Real-Time PCR System_EN
pdf, [5.9 MB]
LightCycler 2.0_CZ
pdf, [1.85 MB]
LightCycler 2.0_EN
pdf, [1.94 MB]
LightCycler 480/480 Instrument II_CZ
pdf, [2.3 MB]
LightCycler 480/480 Instrument II_EN
pdf, [2.18 MB]
LineGene 9600_9600Plus_K_CZ
pdf, [4.66 MB]
LineGene 9600_9600Plus_K_EN
pdf, [4.6 MB]
Mic qPCR Cycler_CZ
pdf, [2.7 MB]
Mic qPCR Cycler_EN
pdf, [2.6 MB]
QuantStudio 3/5 Real-Time PCR System_CZ
pdf, [2.31 MB]
QuantStudio 3/5 Real-Time PCR System_EN
pdf, [2.29 MB]
Rotor-Gene_3000_6000_Q_CZ
pdf, [2.25 MB]
Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]
SLAN Real-Time PCR System_CZ
pdf, [1.59 MB]
SLAN Real-Time PCR System_EN
pdf, [1.56 MB]
StepOne/StepOne Plus Real-Time PCR System_CZ
pdf, [4.37 MB]
StepOne/StepOne Plus Real-Time PCR System_EN
pdf, [4.42 MB]

Product Leaflet

GP_EBV_Leaflet_EN
pdf, [150.16 kB]
Files are available only for registered users.