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GeneProof Enterovirus PCR Kit

CE IVD New product

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 ELIMINATION

  • Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating contamination with amplification products

 

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/050 real-time PCR 50 reactions
GeneProof Enterovirus PCR Kit EV/ISEX/100 real-time PCR 100 reactions

EQA Panels

EQA results

GP_EV_QCMD_2018_EN
pdf, [113.18 kB]
GP_EV_QCMD_2018_EN
pdf, [120.11 kB]
GP_EV_QCMD_2019_EN
pdf, [188.39 kB]
GP_Instand_06.2018_EN
pdf, [1.36 MB]
GP_Instand_06.2019_EN
pdf, [340.8 kB]
Choose all

Technical specification

Technology real-time PCR
Type of Analysis qualitative and semiquantitative
Target sequence specific single copy 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 100.00% (CI95%: 93.75% - 100.00%)
Diagnostic Sensitivity 93.75% (CI95%: 90.63% - 96.88%)
Reporting Units cp/μl
Extraction/Inhibition Control

PCR inhibition and RNA extraction efficiency control 

Validated Specimen CSF, stool*, swab
Storage -20 ± 5 °C
Validated Extraction Methods croBEE NA16 Nucleic Acid Extraction System
GeneProof PathogenFree RNA Isolation Kit
NucleoSpin® RNA Stool
Instruments

ccroBEE 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® 480
LineGene 9600 Plus
Mic qPCR Cycler
Rotor-Gene 3000 / 6000 / Q
SLAN® 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 at www.geneproof.com
Certification CE IVD 

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

** Validated instruments

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.45 MB]
GP_EV_ Instucton for Use_EN
pdf, [242.83 kB]
GP_EV_Advisory_Notice_CZ_EN
pdf, [195.57 kB]

Declaration of Conformity

GP_EV_Declaration of Conformity_EN
pdf, [310.72 kB]

MSDS

GP_Safety Data Sheet_EN
pdf, [148.84 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]
Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]

Product Leaflet

GP_EV_Leaflet_EN
pdf, [550.58 kB]

PCR Template

GP_Enterovirus_Mic_1
micassay, [21.92 kB]
Files are available only for registered users.