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GeneProof Epstein-Barr Virus (EBV) PCR Kit

CE IVD

PRODUCT ADVANTAGES

 

W.H.O. STANDARD BASED QUANTIFICATION

  • Precise and fully traceable quantification according to WHO 1st International Standard NIBSC 09/260

SIMPLE LABORATORY WORKFLOW

  • Easily combinable with other GeneProof PCR kits in one workflow

EASY-TO-USE CONCEPT

  • Single tube Ready-to-Use Master Mix contains all components for PCR amplification
  • No additional PCR reagents pipetting necessary

CONTAMINATION PREVENTION

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

 

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/100 real-time PCR 100 reactions

EQA Panels

EQA results

; GP_Transplatation_QCMD_01_22_EN
pdf, [200.17 kB]
; GP_EBV_QCMD_10_21_EN_02
pdf, [218.58 kB]
; GP_EBV_QCMD_10_21_EN_01
pdf, [218.81 kB]
; GP_EBV_Instand_06_21_EN
pdf, [1 MB]
Choose all

Technical specification

Indication in vitro diagnostic medical device
Regulatory Status CE IVD / EC Directive 98/79/EC
Intended User For professional use in laboratories with trained staff
Test Principle Real-time polymerase chain reaction (PCR) – amplification of the specific Target Sequence and detection using TaqMan probes with fluorophore-based detection
Type of analysis

Qualitative and quantitative

Target Sequence

Gen EBNA1

Analytical Specificity

Epstein-Barr virus, 100 %

Analytical Sensitivity
(LoD with 95% probability)

Sample Processing

Plasma Whole blood CSF BAL   
GeneProof PathogenFree DNA Isolation Kit 196.1 IU/ml 129.2 IU/ml 110.8 IU/ml 206.0 IU/ml
croBEE 201A Nucleic Acid Extraction Kit 289.5 IU/ml 250.2 IU/ml 586.1 IU/ml 138.1 IU/ml
Diagnostic Specificity 94.19 % (CI95%: 86.35 % - 97.84 %)
Diagnostic Sensitivity 99.10 % (CI95%: 96.45 % - 99.84 %)
Positive Predictive Value 97.79 % (CI95%: 94,63 % - 99.18 %)
Negative Predictive Value 94.59 % (CI95%: 90.76 % - 99.58 %)
Linear Range

Extraction method

Precision Plasma Whole blood BAL Precision CSF  
GeneProof PathogenFree DNA Isolation Kit ± 0,5 log 1010 – 102.5 IU/ml 1010 – 102.5 IU/ml 1010 – 102.5 IU/ml ± 0,6 log 1010 – 102.5 IU/ml
croBEE 201A Nucleic Acid Extraction Kit 1010 – 103 IU/ml 1010 – 103 IU/ml 1010 – 103 IU/ml
Dynamic Range 1010 – LoD IU/ml (LoD varying according to the extraction method and material used)
Trueness

-0.07 log (CI95%: -0.13 – 0.00) using manual extraction GeneProof PathogenFree DNA Isolation Kit

-0.08 log (CI95%: -0.13 – 0.03) using automatic extraction croBEE 201A Nucleic Acid Extraction Kit

Precision – repeatability • Intra-assay SD of log concentration = 0.084 (CI95%: 0.068 – 0.110)
Precision – reproducibility

• Inter-assay SD of log concentration = 0.092 (CI95%: 0.059 – 0.202)

• Inter-lot SD of log concentration = 0.112 (CI95%: 0.072 – 0.246)

• Total SD of log concentration = 0.115 (CI95%: 0.074 – 0.254)

Reporting Units

cp/ml

Conversion Factor

1 IU = 1 cp

Metrological Traceability

1st WHO International Standard for Epstein-Barr Virus for Nucleic Acid Amplification Techniques, code: EBV NIBSC 09/260

Extraction / Inhibition Control

PCR inhibition and DNA extraction efficiency control by Internal Standard (IS)

Validated Specimen CSF, plasma, whole blood (EDTA), BAL
Storage Conditions -20 ± 5 °C
Validated Extraction Methods croBEE 201A Nucleic Acid Extraction Kit
GeneProof PathogenFree DNA Isolation Kit
Applied Instruments

croBEE Real-Time PCR System
AMPLilab Real-Time PCR System
Applied Biosystems 7300 / 7500 Real-Time PCR System
AriaMx Real-Time PCR System
BioQuant-96 Real-Time PCR System
CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System
Gentier 96E/96R Real-Time PCR System
LightCycler® 2.0 / 480
LineGene 9600 / 9600 Plus
Mic qPCR Cycler
Montania 4896 Real-Time PCR termocykler
QuantStudio™ 3 / 5 Real-Time PCR System
Rotor-Gene 3000 / Q
SLAN® Real-Time PCR System
StepOneTM / StepOne PlusTM Real-Time PCR System

Detection Channels FAM (EBV), HEX/JOE/VIC (IS)
External Quality Assessment Regularly tested in QCMD and INSTAND e.V. External Quality Assessment Panels -results at www.geneproof.com

Documentation

Instruction for Use

; Declaration of Verification of the kits with medical devices
pdf, [1.6 MB]
; GP_Advisory Notice_ADV-EBV-HHV67-B19-VZV_EN
pdf, [508.26 kB]
; GP_EBV_ Mode d'emploi_FR
pdf, [232.99 kB]
; GP_EBV_Instruction for Use_EN
pdf, [368.75 kB]
; GP_EBV_Instructions_for_Use_ES
pdf, [357 kB]
; GP_EBV_Instructions_for_Use_FR
pdf, [357.1 kB]
; GP_EBV_Instruction_for_Use_IT
pdf, [173.75 kB]

Declaration of Conformity

; GP_EBV_Declaration_of_Conformity_EN
pdf, [617.55 kB]

MSDS

; SDS_GeneProof Epstein-Barr Virus (EBV) PCR Kit
pdf, [276.82 kB]

PCR Template

; GP_DNA_3CH_2CH_ABI7500
edt, [10.72 kB]
; GP_DNA_3CH_2CH_AriaMx
amxt, [3.61 kB]
; GP_DNA_3CH_2CH_croBEE
fqt, [4.91 kB]
; GP_DNA_3CH_2CH_QS5
edt, [8.14 kB]
; GP_DNA_BioRad
prcl, [1.33 kB]
; GP_EBV_Mic
micassay, [13.83 kB]
; RG_DNA_2CH_3CH_4CH
ret, [13.83 kB]

Product Leaflet

; GP_EBV_Leaflet_EN
pdf, [176.19 kB]
; GP_IT_Panel_Leaflet_EN
pdf, [275.02 kB]
; GP_Transplatation_QCMD_01_22_EN
pdf, [200.17 kB]

Manual

; AriaMx Real-Time PCR System_EN
pdf, [2.31 MB]
; Bio-Rad CFX 96/Connect/Dx Real-Time PCR Detection System_EN
pdf, [1.43 MB]
; LightCycler 2.0_EN
pdf, [1.8 MB]
; LightCycler 480/480 Instrument II_EN
pdf, [2.18 MB]
; LineGene 9600_9600Plus_K_EN
pdf, [4.6 MB]
; Mic qPCR Cycler_EN
pdf, [2.33 MB]
; QuantStudio 3/5 Real-Time PCR System_EN
pdf, [1.81 MB]
; Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]
; SLAN Real-Time PCR System_EN
pdf, [1.56 MB]
; StepOne/StepOne Plus Real-Time PCR System_EN
pdf, [4.42 MB]
; ThermoFisher ABI 7500/7500 Fast Real-Time PCR System_EN
pdf, [4.2 MB]
Files are available only for registered users.