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GeneProof Team
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 |
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) |
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 |
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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GeneProof offers a unique PCR testing solution that provides differential diagnostics of many pathogens
Our products’ quality, safety, and performance are fully compliant with the new rules for in vitro…