Leírás
PRODUCT ADVANTAGES
HIGH SENSITIVITY
- Secured by targeting the multicopy sequence of the Intergenic spacer ITS2/28S rDNA
DIFFERENTIATION OF ASPERGILLUS TERREUS
- Enables specific antifungal therapy of resistant aspergillosis
CONTAMINATION ELIMINATION
- Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible contamination with amplification products
HIGH SPECIFICITY
- Detection of a wide range of Aspergillus species
- Aspergillus fumigatus, Aspergillus flavus, Aspergillus niger, Aspergillus clavatus, Aspergillus nidulans, Aspergillus oryzae, Aspergillus ustus, Aspergillus versicolor, Aspergillus niveus, Aspergillus candidus, Aspergillus wentii, Aspergillus foetidus with differentiation of Aspergillus terreus
COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES
CE IVD CERTIFIED DIAGNOSTIC TEST
Technical specification
| Indication | in vitro diagnostic medical device |
| Regulatory Status | CE IVD / EC Directive 98/79/EC |
| Intended User | For professional use in laboratories with trained staff |
| Technology | Real-time PCR |
| Type of Analysis | Qualitative |
| Target Sequence | ITS2/28S rDNA region |
| Analytical Specificity | Aspergillus spp., 100 % Aspergillus terreus, 100 % |
| Analytical Sensitivity (LoD with 95% probability) | 40.76 cp/ml, performed on AmpliRun® Aspergillus fumigatus DNA control (Vircell) |
| Extraction/Inhibition Control | PCR inhibition and DNA extraction efficiency control by Internal Standard (IS) |
| Validated Specimen | Whole blood, plasma, serum, BAL, sputum, CSF |
| Storage | -20 ± 5 °C |
| Validated Extraction Methods | croBEE 201A Nucleic Acid Extraction Kit GeneProof PathogenFree DNA Isolation Kit |
| Validated Instruments | croBEE Real-Time PCR System Applied Biosystems 7500 Real-Time PCR System Aria Mx 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 AMPLilab Bio Quant-96 SLAN® Real-Time PCR System |
| Required Detection Channels | FAM (ASPspp), Cy5 (ASPT), HEX/JOE/VIC (IS) |
| External Quality Assessment | regularly tested by QCMD External Quality Assessment panels – results at www.geneproof.com |
