GeneProof Aspergillus PCR Kit
CE IVD
PRODUCT DETAIL
The PCR kit is designed for the detection of the clinically significant Aspergillus species (A. fumigatus, A. flavus, A. niger, A. terreus) by the real-time Polymerase Chain Reaction (PCR) method.
The Aspergillus spp. detection consists in amplification of a specific ribosomal DNA sequence and in measurement of fluorescence increase. The Aspergillus spp. presence is indicated by the FAM fluorophore fluorescence growth and the presence of Aspergillus terreus is indicated by the Cy5 fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR by amplification products. The kit is designed for in vitro diagnostics and provides qualitative detection.
TECHNICAL SPECIFICATION
| Technology | real-time PCR |
| Type of Analysis | qualitative |
| Target Sequence | ITS2/28S rDNA region |
| Specificity | Aspergillus spp. (A. fumigatus, A. flavus, A. niger), 100 % Aspergillus terreus, 100 % |
| Sensitivity (LoD) | reaches up to 48.838 ge/µl with the probability of 95 % (on Amplirun® Aspergillus fumigatus DNA control, Vircell) |
| Extraction/Inhibition Control |
PCR inhibition control (ISIN version) PCR inhibition and DNA extraction efficiency control (ISEX version) |
| Validated Specimen | BAL, CSF, plasma, serum, sputum, whole blood |
| Storage | -20 ± 5 °C |
| Validated Extraction Methods | croBEE NA16 Nucleic Acid Extraction System 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 PlusMic qPCR CyclerQuantStudio™ 5 Real-Time PCR System Rotor-Gene 3000/Q SLAN® Real-Time PCR System |
| Required Detection Channels | FAM, HEX, Cy5 |
| Quality Control | Quality management system is certified in compliance with the requirements of the standard ISO 13485 |
| External Quality Assessment | regularly tested by QCMD External Quality Assessment panels – results at www.geneproof.com |
| Certification | CE IVD for in vitro Diagnostics Use |
ORDER INFORMATION
| Product name | Cat. No. | Technology | Package |
| GeneProof Aspergillus PCR Kit | ASP/ISIN/025 | real-time PCR | 25 reaction |
| GeneProof Aspergillus PCR Kit | ASP/ISIN/050 | real-time PCR | 50 reaction |
| GeneProof Aspergillus PCR Kit | ASP/ISIN/100 | real-time PCR | 100 reaction |
| GeneProof Aspergillus PCR Kit | ASP/ISEX/025 | real-time PCR | 25 reaction |
| GeneProof Aspergillus PCR Kit | ASP/ISEX/050 | real-time PCR | 50 reaction |
| GeneProof Aspergillus PCR Kit | ASP/ISEX/100 | real-time PCR | 100 reaction |