GeneProof Aspergillus PCR Kit

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

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