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GeneProof Aspergillus PCR Kit

CE IVD

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

SIMPLE LABORATORY WORKFLOW

  • Easily combinable with other GeneProof PCR kits in one workflow

EASY-TO-USE CONCEPT

  • Single tube Ready-to-Use Master Mix contains all components for PCR amplification
  • No additional PCR reagents pipetting necessary

CONTAMINATION PREVENTION

  • Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible carryover contamination

 

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE IVD CERTIFIED DIAGNOSTIC TEST

Order information

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

EQA Panels

EQA results

; GP_ASP_QCMD_12_20_EN_02
pdf, [153.48 kB]
; GP_ASP_QCMD_12_20_EN_01
pdf, [151.85 kB]
Choose all

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. (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
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 RT PCR System
Bio Quant-96
Gentier 96E/96R Real-Time PCR System
SLAN® 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

Documentation

Instruction for Use

; Declaration of Verification of the kits with medical devices
pdf, [1.6 MB]
; GP_ASP_Advisory_Notice_02_22_EN_CZ
pdf, [664.96 kB]
; GP_ASP_Advisory_Notice_05_22_EN
pdf, [556.78 kB]
; GP_ASP_Instruction_for_Use_EN
pdf, [296.98 kB]

Declaration of Conformity

; GP_ASP_Declaration_of_Conformity_EN
pdf, [603.57 kB]

MSDS

; GP_ASP_Safety_Data_Sheet_EN
pdf, [273.76 kB]

PCR Template

; GP_Aspergillus_Mic
micassay, [26.54 kB]
; GP_DNA_3CH_2CH_ABI7500
edt, [10.72 kB]
; GP_DNA_3CH_2CH_AriaMx
amxt, [3.61 kB]
; GP_DNA_3CH_2CH_croBEE
fqt, [4.91 kB]
; GP_DNA_3CH_2CH_QS5
edt, [8.14 kB]
; GP_DNA_BioRad
prcl, [1.33 kB]
; RG_DNA_2CH_3CH_4CH
ret, [13.83 kB]

Product Leaflet

; GP_ASP_Leaflet_EN
pdf, [207.51 kB]
; GP_IT_Panel_Leaflet_EN
pdf, [275.02 kB]

Manual

; AriaMx Real-Time PCR System_EN
pdf, [2.31 MB]
; Bio-Rad CFX 96/Connect/Dx Real-Time PCR Detection System_EN
pdf, [1.43 MB]
; LightCycler 480/480 Instrument II_EN
pdf, [2.18 MB]
; LineGene 9600_9600Plus_K_EN
pdf, [4.6 MB]
; Mic qPCR Cycler_EN
pdf, [2.33 MB]
; QuantStudio 3/5 Real-Time PCR System_EN
pdf, [1.81 MB]
; Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]
; SLAN Real-Time PCR System_EN
pdf, [1.56 MB]
; ThermoFisher ABI 7500/7500 Fast Real-Time PCR System_EN
pdf, [4.2 MB]
Files are available only for registered users.

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