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GeneProof VRE PCR Kit

CE IVD

PRODUCT ADVANTAGES

 

DIRECT DETECTION FROM CLINICAL MATERIAL

  • No need of previous cultivation
  • Quick result from primary clinical material

IDENTIFICATION OF vanA AND vanB

  • Detects and distinguishes vanA and vanB genes
  • Enables choosing appropriate therapy

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

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

SIMPLE LABORATORY WORKFLOW

  • Easily combinable with other GeneProof PCR kits in one workflow

 

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE IVD CERTIFIED DIAGNOSTIC TEST

Order information

Product name Catalog no. Technology Packaging
GeneProof VRE PCR Kit VRE/ISEX/025 real-time PCR 25 reactions
GeneProof VRE PCR Kit VRE/ISEX/100 real-time PCR 100 reactions

EQA Panels

EQA results

; GP_VRE_QCMD_12_20_EN
pdf, [147.51 kB]
; GP_VRE_Instand_06_21_EN
pdf, [901.27 kB]
Choose all

Technical specification

Indication in vitro diagnostic medical device
Regulatory Status CE IVD
Intended User For professional use in laboratories with trained staff
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 %

Analytical Sensitivity (LoD with 95% probability)

For vanA reaches 1.398 cp/μl
For vanB reaches 1.026 cp/μl

Extraction/Inhibition Control

PCR inhibition and DNA extraction efficiency control 

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

croBEE 201A Nucleic Acid Extraction System
GeneProof PathogenFree DNA Isolation Kit

Validated Instruments

croBEE Real-Time PCR System
AMPLilab Real-Time PCR System
Applied Biosystems 7500 Real-Time PCR System
AriaMx Real-Time PCR System
BioQuant-96 Real-Time PCR System
CFX96™ / Dx Real-Time PCR Detection System
Gentier 96E/96R Real-Time PCR System
LightCycler® 480
LineGene 9600 / 9600 Plus
Mic qPCR Cycler
Rotor-Gene 3000 / Q
QuantStudio™ 5 Real-Time PCR System
SLAN® Real-Time PCR System

Required Detection Channels

FAM, HEX, Cy5

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_VRE_Advisory_Notice_09_22_EN
pdf, [805.58 kB]
; GP_VRE_Instruction_for_Use_EN
pdf, [139.55 kB]

Declaration of Conformity

; GP_VRE_Declaration of Conformity_EN
pdf, [296.83 kB]

MSDS

; GP_ VRE_SDS PCR Kit
pdf, [274.98 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_VRE_Mic
micassay, [27.74 kB]
; RG_DNA_2CH_3CH_4CH
ret, [13.83 kB]

Product Leaflet

; GP_VRE_Leaflet_EN
pdf, [157.16 kB]
; GP_VRE_Poster_EN
pdf, [200.48 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 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]
; ThermoFisher ABI 7500/7500 Fast Real-Time PCR System_EN
pdf, [4.2 MB]
Files are available only for registered users.

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