GeneProof Bordetella pertussis/parapertussis PCR Kit
Kat.: BP/ISEX/025
A termék CE/IVD minősítéssel rendelkezik és az OGYÉI által nyilvántartásba vett.
Az Bordetella pertussis és Bordetella parapertussis elkülönítésére és detektálására alkalmas ‘Ready-to-Use ‘ master mix. Az IS1002 (mind a Bordetella pertussisra/parapertussisra specifikus) és az IS1001 (csak a B. parapertussisra jellemző) több kópiás inszertációs szekvenciák amplifikációja. (25 reakció)
Leírás
PRODUCT ADVANTAGES
MORE INFORMATION WITH LESS SAMPLES
- Detects and distinguishes Bordetella pertussis and Bordetella parapertussis in a single reaction tube
UNIVERSAL PCR PROFILE
- Easily combinable with other PCR kits from the Respiratory Infections group, especially with GeneProof Mycoplasma pneumoniae PCR Kit and GeneProof Chlamydia pneumonia PCR Kit
- Simplifies laboratory workflow
HIGHLY SPECIFIC DETECTION
- Amplification of the multi-copy insertion sequences IS1002 (specific for both Bordetella pertussis/parapertussis) and IS1001 (specific only for B. parapertussis)
- No false-positive results for Bordetella holmesii
CONTAMINATION ELIMINATION
- Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible 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 |
| Target Sequence | the multi-copy insertion sequences IS1002 (specific for both Bordetella pertussis/parapertussis) and IS10001 (specific only for B. parapertussis) |
| Analytical Specificity | B. pertussis, 100 % B. parapertussis, 100 % |
| Analytical Sensitivity (LoD) | reaches up to 0.212 cp/µl with the probability 95 % (on Amplirun® Bordetella pertussis DNA control, Vircell) |
| Extraction/Inhibition Control | PCR inhibition and DNA extraction efficiency control |
| Validated Specimen | aspirate, sputum, swab |
| Storage | -20 ± 5 °C |
| Validated Extraction Methods | croBEE NA16 Nucleic Acid Extraction System GeneProof PathogenFree DNA Isolation Kit |
| Instruments | croBEE Real-Time PCR System* AriaMx Real-Time PCR System CFX96™ / Dx Real-Time PCR Detection System LightCycler® 480 LineGene 9600 / 9600 Plus Mic qPCR Cycler QuantStudio™ 5 Real-Time PCR System Rotor-Gene 3000 / Q SLAN® Real-Time PCR System |
| Required Detection Channels | FAM, HEX, Cy5 |
| External Quality Assessment | regularly tested by QCMD and Instand e.V. External Quality Assessment panels – for results see www.geneproof.com |
| Certification | CE IVD |
*Validated instruments
