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Enterovirus PCR Kit

Short description

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.

Product highlights

  • Qualitative and quantitative detection
  • Not affected by presence of Rhinovirus
  • Design according to ENPEN requirements
  • No additional PCR reagents pipetting necessary

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Enterovirus PCR Kit

Specifications of the Enterovirus PCR Kit

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.

Components of the Enterovirus PCR Kit
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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