GeneProof Epstein-Barr Virus (EBV) PCR Kit

GeneProof Epstein-Barr Virus (EBV) PCR Kit

 CE IVD

PRODUCT DETAIL

The PCR kit is designed for detection of Epstein-Barr virus (EBV) by the real-time Polymerase Chain Reaction (PCR) method.

The EBV detection consists in amplification of a specific conservative DNA sequence of the single copy gene encoding the nuclear antigen 1 (EBNA1) and in measurement of fluorescence increase. The EBV presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is 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 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)
Linear Range 1010 – 102.5 IU/ml with precision of ± 0.5 log
Reporting Units cp/μl
Conversion Factor 1 IU = 1 cp
Metrological Traceability NIBSC EBV 09/260
Extraction / Inhibition Control PCR inhibition control (ISIN version)

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/ISIN/025 real-time PCR 25 reactions
GeneProof Epstein-Barr Virus (EBV) PCR Kit EBV/ISIN/050 real-time PCR 50 reactions
GeneProof Epstein-Barr Virus (EBV) PCR Kit EBV/ISIN/100 real-time PCR 100 reactions
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

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