The GeneProof Enterovirus PCR Kit is a high-quality solution for the detection and monitoring of Enterovirus species A-D, including Coxsackievirus, Echovirus, Enterovirus, Poliovirus, and the newly discovered Enterovirus group EV-C104. The kit amplifies a single-copy 5′ UTR RNA sequence in accordance with European Non-Polio Enterovirus Network (ENPEN) requirements and is suitable for use as a primary screening method. The kit offers high specificity and is not affected by the presence of Rhinovirus. The kit allows for qualitative and quantitative detection, enabling the monitoring of pathogen levels over time. Its easy-to-use concept and Ready-to-Use Master Mix eliminate the need for additional PCR reagents pipetting, simplifying the laboratory workflow. Additionally, the Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs to prevent carryover contamination. The kit is compatible with a wide range of real-time PCR devices and is a CE IVD certified diagnostic test, guaranteeing top-notch quality and reliability.
Instructions for Use
Declaration of Conformity
MSDS
Publications
Manual
PCR Templates
Introducing the GeneProof Enterovirus PCR Kit, a highly reliable and efficient solution for the detection and monitoring of Enterovirus infections. This advanced PCR kit is designed according to European Non-Polio Enterovirus Network (ENPEN) requirements, amplifying a single-copy 5′ UTR RNA sequence that serves as the target sequence. It is suitable for use as a primary screening method and boasts high specificity, detecting all Enterovirus species A-D, including Coxsackievirus, Echovirus, Enterovirus, Poliovirus, and the newly discovered Enterovirus group EV-C104. Notably, this kit is not affected by the presence of Rhinovirus.
The GeneProof Enterovirus PCR Kit offers both qualitative and quantitative detection, enabling the monitoring of pathogen levels over time. Its easy-to-use concept, with a single tube Ready-to-Use Master Mix that contains all components for PCR amplification, eliminates the need for additional PCR reagents pipetting, simplifying laboratory workflow.
Contamination prevention is also assured with the kit’s Master Mix containing Uracil-DNA glycosylase (UNG) and dUTPs, effectively eliminating any carryover contamination.
This CE IVD certified diagnostic test is compatible with a wide range of real-time PCR devices, ensuring that users have access to reliable and accurate results, anytime, anywhere.
Trust in the GeneProof Enterovirus PCR Kit for the detection and monitoring of Enterovirus infections, delivering unmatched sensitivity, specificity, and accuracy for the reliable diagnosis and management of Enterovirus infections.
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 and semiquantitative |
Target sequence | 5‘ UTR RNA sequence |
Analytical Specificity | Enterovirus A-D, 100 % |
Analytical Sensitivity (LoD with 95% probability) | 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 in 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
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