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GeneProof Legionella pneumophila PCR Kit

CE IVD

PRODUCT ADVANTAGES

 

HIGH SENSITIVITY

  • Secured by targeting the multicopy sequence of the 16S rRNA gene

SIMPLE LABORATORY WORKFLOW

  • Easily combinable with other GeneProof PCR kits in one workflow

RELIABLE DETECTION OF LEGIONELLA SP.

  • Enables detection of Legionella sp. using 3-channel system

CONTAMINATION PREVENTION

  • Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating 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 Legionella pneumophila PCR Kit LP/ISEX/025 real-time PCR 25 reactions
GeneProof Legionella pneumophila PCR Kit LP/ISEX/100 real-time PCR 100 reactions

Product Leaflet

Product Leaflet

; GP_LP_Leaflet_EN
pdf, [144.73 kB]
Choose all

EQA Panels

EQA results

; GP_LP_QCMD_05_22_EN
pdf, [176.48 kB]
; GP_LP_QCMD_06_21_EN
pdf, [179.88 kB]
; GP_LP_Instand_06_2021_EN
pdf, [901.22 kB]
Choose all

Technical specification

Indication in vitro diagnostic medical device
Regulatory Status CE IVD
Intended User For professional use in laboratories with trained staff
Technology Real-time PCR
Type of Analysis Qualitative
Target Sequence The gene encoding 16S rRNA specific for L. pneumophila 
Analytical Specificity

L. pneumophila, 100 %

Analytical Sensitivity (LoD)

Reaches up to 0.578 cp/μl with the probability of 95% (on Amplirun® Legionella pneumophila DNA control, Vircell)

Extraction/Inhibition Controls

PCR Inhibition and DNA extraction efficiency control 

Validated specimen BAL, sputum, swab
Storage -20 ± 5 °C
Validated Extraction Methods croBEE 201A Nucleic Acid Extraction System
GeneProof PathogenFree DNA Isolation Kit
Instruments

ccroBEE Real-Time PCR System
Applied Biosystems 7300 / 7500 Real-Time PCR System
AriaMx Real-Time PCR System
CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System
LightCycler® 2.0 / 480
LineGene 9600 / 9600 Plus
Mic qPCR Cycler
QuantStudio™ 3 / 5 Real-Time PCR System
Rotor-Gene 3000 / Q
SLAN® Real-Time PCR System
StepOne™ / StepOnePlus™ Real-Time PCR System

Required Detection Channels FAM, HEX
External Quality Assessment Regularly tested in QCMD and Instand e.V. External Quality Assessment Panels - results at www.geneproof.com

Instructions for Use

; Declaration of Verification of the kits with medical devices
pdf, [1.61 MB]
; GP_LP_Declaration of Change_EN_CZ
pdf, [197.6 kB]
; GP_LP_Instruction for Use_EN
pdf, [542.61 kB]

Declaration of Conformity

; GP_LP_Declaration_of_Conformity_EN
pdf, [580.53 kB]

MSDS

; GP_LP_Safety_Data_Sheet_EN
pdf, [274.77 kB]

Publications

; GP_RESPIRATORY_Publications_10_2022_EN
pdf, [142.69 kB]

PCR Template

; 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]
; GP_Legionella pneumophila_Mic
micassay, [21.96 kB]
; RG_DNA_2CH_3CH_4CH
ret, [13.83 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 2.0_EN
pdf, [1.8 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]
; StepOne/StepOne Plus Real-Time PCR System_EN
pdf, [4.42 MB]
; ThermoFisher ABI 7500/7500 Fast Real-Time PCR System_EN
pdf, [4.2 MB]
Files are available only for registered users.