GeneProof Enterovirus PCR Kit

CE IVD 

 

PRODUCT DETAIL

The PCR kit is intended for detection of Enterovirus RNA by the real-time Polymerase Chain Reaction (PCR) method.


The Enterovirus detection consists in amplification of a single-copy 5' UTR RNA sequence and in measurement of fluorescence increase. The presence of Enterovirus is indicated by the increased FAM fluorophore fluorescence. An Internal Control (IC), which is a part of the PCR kit, is used as a control for the whole diagnostic process, i.e. RNA extraction efficiency, reverse-transcription step efficiency (transcription of RNA into cDNA) and PCR amplification efficiency (PCR inhibition). The IC positive amplification is detected in the HEX fluorophore fluorescence channel. The PCR kit is designed for in vitro diagnostics for qualitative and semiquantitative detection and it utilizes the "hot start" technology minimizing non-specific reactions and ensuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG) which eliminates possible contamination of the PCR with amplification products.

 

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 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)
 Reporting Units  cp/µl
 Extraction/Inhibition Control  PCR inhibition and RNA extraction efficiency control (ISEX version)
 Validated Specimen

 CSF, stool*, swab

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

 Storage -20 ± 5 °C
 Validated Extraction Methods croBEE NA16 Nucleic Acid Extraction System
GeneProof PathogenFree RNA Isolation Kit
NucleoSpin® RNA Stool
 Instruments croBEE Real-Time PCR System*
Applied Biosystems 7300 / 7500 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
Regulatory Status

CE IVD

 * Validated instruments

ORDER INFORMATION

Product name

Cat. No. Technology Package
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