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GeneProof MRSA PCR Kit

CE IVD

PRODUCT ADVANTAGES

 

WIDE RANGE OF MRSA CHROMOSOMAL CASSETTE DETECTION

  • Detects MRSA chromosomal cassettes I. – XI.

MULTI TARGET DETECTION

  • Enables testing both mecA / mecC genes
  • Recognizes empty cassettes

DIRECT DETECTION FROM CLINICAL MATERIAL

  • No need of previous cultivation
  • Quick result from primary clinical material

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

  • 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 MRSA PCR Kit MRSA/ISEX/025 real-time PCR 25 reactions
GeneProof MRSA PCR Kit MRSA/ISEX/100 real-time PCR 100 reactions

EQA Panels

EQA results

; GP_MRSA_QCMD_06_21_EN
pdf, [175.79 kB]
; GP_MRSA_QCMD_06_20_EN_croBEE
pdf, [175.62 kB]
; GP_MRSA_QCMD_06_20_EN
pdf, [174.67 kB]
; GP_MRSA_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

nuc gene, which is specific for Staphylococcus aureus 
SCCmec/orfX junction region
Resistance gene mecA/mecC

Analytical Specificity

Methicillin-Resistant Staphylococcus aureus (MRSA)

Analytical Sensitivity (LoD with 95% probability)

2.81 ge/µl (on NCTC strain 13142)

Extraction/Inhibition Control

PCR Inhibition and DNA extraction efficiency control 

Validated specimen

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

croBEE Real-Time PCR System
AMPLilab Real-Time PCR System
Applied Biosystems 7500 Real-Time PCR System
AriaMx Real-Time PCR System
CFX96™ / Dx Real-Time PCR Detection System
Gentier 96E/96R Real-Time PCR System
LineGene 9600 / 9600 Plus
QuantStudio™ 5 Real-Time PCR System
Rotor-Gene 3000 / Q

Required Detection Channels FAM, HEX, Cy5, Texas Red
External Quality Assessment Regularly tested in QCMD and Instand e.V. 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_MRSA_Advisory_Notice_09_22_EN
pdf, [513.34 kB]
; GP_MRSA_Instruction_for_Use_EN
pdf, [140.15 kB]

Declaration of Conformity

; GP_MRSA_Declaration_of_Conformity_EN
pdf, [582.61 kB]

MSDS

; GP_MRSA_Safety_Data_Sheet_EN
pdf, [274.74 kB]

PCR Template

; GP_DNA_4CH_ABI7500
edt, [10.36 kB]
; GP_DNA_4CH_AriaMx
amxt, [3.72 kB]
; GP_DNA_4CH_croBee
fqt, [4.94 kB]
; GP_DNA_4CH_QS5
edt, [8.21 kB]
; GP_DNA_BioRad
prcl, [1.33 kB]
; RG_DNA_2CH_3CH_4CH
ret, [13.83 kB]

Product Leaflet

; GP_MRSA_Leaflet_EN
pdf, [153.78 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]
; LineGene 9600_9600Plus_K_EN
pdf, [4.6 MB]
; QuantStudio 3/5 Real-Time PCR System_EN
pdf, [1.81 MB]
; Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 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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