Welcome to GeneProof website!

It is great to see you here. To see all contents of the website, please register or restore your access.
We believe you will come back gladly.

GeneProof Team

 

User account
Forgot your password?
Searching

GeneProof Enterovirus PCR Kit

CE IVD

PRODUCT ADVANTAGES

 

COMPLIANCE WITH ENPEN REQUIREMENTS

  • Amplification of a single-copy 5‘ UTR RNA sequence which is required as the target sequence by European non-polio enterovirus network (ENPEN)
  • Suitable for using as primary screening method

DETECTION OF ALL HUMAN ENTEROVIRUS SPECIES

  • The kit enables detection of Enterovirus species A-D including Coxsackievirus, Echovirus, Enterovirus, Poliovirus and the newly discovered Enterovirus group EV-C104 with nucleotide changes in 5´-UTR sequence.
  • The kit does not include Rhinovirus detection

QUALITATIVE AND SEMIQUANTITATIVE DETECTION

  • Monitoring of pathogen level in time

CONTAMINATION PREVENTION

  • Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating 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 Enterovirus PCR Kit EV/ISEX/025 real-time PCR 25 reactions
GeneProof Enterovirus PCR Kit EV/ISEX/100 real-time PCR 100 reactions

EQA Panels

EQA results

; GP_EV_QCMD_05_22_EN
pdf, [129.32 kB]
; GP_EV_Instand_06_21_EN
pdf, [1 MB]
; GP_EV_QCMD_08_21_EN
pdf, [129.5 kB]
; GP_EV_QCMD_08_21_EN
pdf, [129.65 kB]
; GP_EV_QCMD_05_21_EN
pdf, [130.94 kB]
; GP_EV_QCMD_05_21_EN
pdf, [130.76 kB]
; GP_EV_Instand_06_21_EN
pdf, [1 MB]
Choose all

Technical specification

Indication in vitro diagnostic medical device
Intended User For professional use in laboratories with trained staff
Regulatory Status CE IVD
Technology Real-time PCR
Type of Analysis Qualitative and semiquantitative
Target sequence 5‘ UTR RNA sequence
Analytical Specificity Enterovirus A-D, 100 %
Analytical Sensitivity (LoD)

reaches up to 158.34 cp/μl with the probability of 95 % (on Amplirun® Enterovirus 68 RNA control, Vircell)
reaches up to 0.57 cp/μl with the probability of 95 % (on Amplirun® Enterovirus 71 RNA control, Vircell)
reaches up to 0.59 cp/μl with the probability of 95 % (on Amplirun® Coxsackie B5 RNA control, Vircell)

Diagnostic Specificity 93.75% (CI95%: 77.78% - 98.91%)
Diagnostic Sensitivity 98.72% (CI95%: 92.09% - 99.93%)
Reporting Units cp/μl
Extraction/Inhibition Control

PCR inhibition and RNA extraction efficiency control by Internal Control (IC) 

Validated Specimen CSF, stool*, swab
Storage -20 ± 5 °C
Validated Extraction Methods croBEE 201A Nucleic Acid Extraction System
GeneProof PathogenFree RNA Isolation Kit
NucleoSpin® RNA Stool
Instruments

croBEE Real-Time PCR System
AMPLilab Real-Time PCR System
Applied Biosystems 7300 / 7500 Real-Time PCR System
AriaMx Real-Time PCR System
BioQaunt-96 Real-Time PCR System
CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System
Gentier 96E/96R Real-Time PCR System
LightCycler® 480
LineGene 9600 Plus
Mic qPCR Cycler
QuantStudioTM 3 / 5 Real-Time PCR System
Rotor-Gene 3000 / 6000 / Q
SLAN® Real-Time PCR System

Detection Channels FAM, HEX/JOE/VIC
External Quality Assessment Regularly tested by QCMD and INSTAND e.V. External Quality Assessment panels – results at www.geneproof.com

*Only in combination with NucleoSpin® RNA Stool or croBEE NA16 Nucleic Acid Extraction System

Documentation

Instruction for Use

; Declaration of Verification of the kits with medical devices
pdf, [1.55 MB]
; GP_EV_Advisory_Notice_05_22_EN
pdf, [996.29 kB]
; GP_EV_Advisory_Notice_CZ_EN
pdf, [195.57 kB]
; GP_EV_Instruction_for_Use_EN
pdf, [323.09 kB]

Declaration of Conformity

; GP_EV_Declaration_of_conformity_EN
pdf, [610.36 kB]

MSDS

; GP_EV_Safety_Data_Sheet_EN
pdf, [277.92 kB]

PCR Template

; GP_Enterovirus_Mic
micassay, [21.92 kB]
; GP_UNI_3CH_2CH_ABI7500
edt, [10.33 kB]
; GP_UNI_3CH_2CH_AriaMx
amxt, [3.64 kB]
; GP_UNI_3CH_2CH_CroBee
fqt, [4.9 kB]
; GP_UNI_3CH_2CH_QS5
edt, [8.13 kB]
; GP_UNI_BioRad
prcl, [1.33 kB]
; RG_UNI_2CH_3CH_4CH
ret, [13.83 kB]

Product Leaflet

; GP_EV_Leaflet_EN
pdf, [550.58 kB]

Manual

; Bio-Rad CFX 96/Connect/Dx Real-Time PCR Detection System_EN
pdf, [1.43 MB]
; croBEE Real-Time PCR System_EN
pdf, [5.9 MB]
; Mic qPCR Cycler_EN
pdf, [2.33 MB]
; Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]
Files are available only for registered users.