GeneProof Enterovirus PCR Kit
Kat.: EV/ISEX/025
A termék CE/IVD minősítéssel rendelkezik és az OGYÉI által nyilvántartásba vett.
Az Enterovírus A-D fajok, beleértve a Coxsackievírust, Echovírust, Enterovírust, Poliovírust és az újonnan felfedezett Enterovírus EV-C104 csoportot (5′-UTR szekvenciájának nukleotid változásaival) detektálására alkalmas, ‘Ready-To-Use’ master mix. A kit nem alkalmas Rhinovirus detektációra. Az egy kópiás 5‘ UTR RNS szekvenciát célozza. (25 reakció)
Leírás
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
Technical specification
| Indication | in vitro diagnostic medical device |
| Intended User | For professional use in laboratories with trained staff |
| 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 | croBEE 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
