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GeneProof Team
Product name | Catalog no. | Technology | Packaging |
GeneProof Aspergillus PCR Kit | ASP/ISEX/025 | real-time PCR | 25 reactions |
GeneProof Aspergillus PCR Kit | ASP/ISEX/100 | real-time PCR | 100 reactions |
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. (A. fumigatus, A. flavus, A. niger, A. oryzae, A. candidus, A. foetidus, A. nidulans, A. ustus, A. versicolor, A. wentii, A. clavatus, A. niveus) (ASPspp), 100 % Aspergillus terreus (ASPT), 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 |
Required Detection Channels | FAM (ASPspp), Cy5 (ASPT), HEX/JOE/VIC (IS) |
External Quality Assessment | Regularly tested in QCMD External Quality Assessment panels – results at www.geneproof.com |
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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…