GeneProof VRE PCR Kit

CE IVD 

 

PRODUCT DETAIL

The PCR kit is designed for the detection of Vancomycin-Resistant Enterococci (VRE), e. g. Enterococcus faecalis and Enterococcus faecium, by the real-time Polymerase Chain Reaction (PCR) method.

The VRE detection consists in amplification of a specific conservative DNA sequence in the area of the vanA and vanB genes and in measurement of fluorescence increase. The vanA gene presence is indicated by the FAM fluorophore fluorescence growth and the vanB gene presence is indicated by the Cy5 fluorophore fluorescence growth. An Internal Standard (IS)          is either 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 detection.

 

TECHNICAL SPECIFICATION 

Technology real-time PCR
Type of Analysis qualitative
Target Sequence specific conservative DNA sequence in the area of the vanA and vanB genes
Specificity

vanA, vanB genes (e. g. Enterococcus faecalis, Enterococcus faecium, Enterococcus gallinarium, etc.), 100 %

Sensitivity (LoD)

for vanA reaches 1.398 cp/μl with the probability of 95 %
for vanB reaches 1.026 cp/μl with the probability of 95 %

Extraction/Inhibition Control

PCR inhibition control (ISIN version)
PCR inhibition and DNA extraction efficiency control (ISEX version)

Validated Specimen sputum, stool, urine
Storage -20 ± 5 °C
Validated Extraction Methods

croBEE NA16 Nucleic Acid Extraction System
GeneProof PathogenFree DNA Isolation Kit

Instruments

croBEE Real-Time PCR System*
Applied Biosystems 7500 Real-Time PCR System
AriaMx Real-Time PCR System
CFX96™ / Dx Real-Time PCR Detection System
LightCycler® 480
LineGene 9600 / 9600 Plus

Mic qPCR Cycler

QuantStudio™ 5 Real-Time PCR System
Rotor-Gene 3000 / Q
SLAN® Real-Time PCR System

Required Detection Channels

FAM, HEX, Cy5

Quality Control quality management system is certified in compliance with the requirements of the standard ISO 13485
External Quality Assessment regularly tested by QCMD and Instand e.V. External Quality Assessment panels – results at www.geneproof.com
Certification CE IVD for in vitro Diagnostics Use

 *validated instrument

ORDER INFORMATION

Product name

Cat. No. Technology Package
GeneProof VRE PCR Kit VRE/ISEX/025 real-time PCR 25 reactions
GeneProof VRE PCR Kit VRE/ISEX/050 real-time PCR 50 reactions
GeneProof VRE PCR Kit VRE/ISEX/100 real-time PCR 100 reactions