MRSA Test System - Greiner Bio-One

MRSA ?
= 75min
GENSPEED ®
Test System
MRSA
Setting the pace - Precise
MRSA results within 75 minutes
in cooperation with Amplex Diagnostics
www.gbo.com

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GENSPEED ®
Setting the pace!
The new, revolutionary GENSPEED ®
MRSA Test
System from Greiner Bio-One is an in vitro diagnostic
tool for qualitative detection of methicillin resistant
staphylococcus aureus (MRSA) in human nasal and
pharyngeal smears.
This bacterium is recognized worldwide as the most
significant cause of nosocomial infections.
MRSA Test System
GENSPEED ®
MRSA was developed as a time
and cost saving rapid test for low throughput testing
applications in hospitals and laboratories.
The main advantage of the product lies in the
acceleration of the analysis, providing reliable results
within merely 75 minutes.
GENSPEED ®
MRSA was developed in cooperation with Amplex Diagnostics, our partner with years of
expertise in developing tests for detecting nosocomial infections.

Sensitivity owing to PCR technology, combined with the speed
and specificity of the GENSPEED ®
Test System
- ready to use with a short turnaround time!
Whith an average 7-day prolongation and additional
expenses of 1,600.- Euro per patient / day, the
question is no longer whether an MRSA screening
should be carried out nor not, but rather, which test
system should be used.
Conventional culture for MRSA analysis takes up to 48
hours, leading to additional care and treatment costs
for the necessary quarantine days.
Other molecular biological systems have been
developed for high throughput application. Since due
3. Detection & Reporting
2. Denaturation &
Hybridization
65 Min
69 Min
2.
3.
75 Min
to economic reasons it is often necessary to wait for a
certain number of patient samples before testing, the
results for one patient are often not available until the
next day.
The GENSPEED ®
MRSA Test System
is particulary suitable for low throughput
applications with a turnaround time (TAT)
of only 75 minutes!
Precise MRSA results within 75 minutes
1.
1. Lysis & DNA amplification
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The advantages of the new GENSPEED ®
4
Fast turnaround time (TAT)
Speed
MRSA Test System
The speed of the test speaks for itself. With only 75 minutes from sample collection to result,
GENSPEED ®
MRSA is among the fastest test systems on the market.
Individual sample analysis at any time
Each sample can be analyzed immediately. No batching required.
Unique detection of the new resistance gene mecC
GENSPEED ®
Differential diagnostics
MRSA is the first test system in the world for the detection of mecC.
Preliminary studies have demanded new detection
methods for mecC, to ensure identification
of MRSA in the future. [2,3,4,5,6]
GENSPEED ®
MRSA distinguishes MRSA from MRSE
or mecA/C positive S.haemolyticus using its ability to
simultaneously detect multiple analytes (multiplexing).
High degree of accuracy
Three controls (Negative control, PCR
control, and implementation control)
ensure the accuracy of the
results.
One swab for everything
One and the same swab for
GENSPEED ®
MRSA and
bacterial culture.

The resistance behaviour to methicillin is encoded
by the Staphylococcus Cassette Chromosome mec
(SCCmec). [7]
So-called “Empty Cassette Variants” are a problem for
many MRSA test systems on the market. These are
S.aureus strains whose gene cassette does not contain
the resistance gene mecA (deletion) therefore they
are sensitive to methicillin (treatment with antibiotics
possible). Test systems which target the cassette as an
entity, disregard the mecA gene and yield false positive
results.
Technical advantages at a glance
Easy handling
Objective results
Optional interfacing
with your LIMS*
No false positive results due to “Empty Cassette Variants”
and no false negative results due to the neglect
of the new resistance gene mecC
Moreover, in 2011 the new gene variant mecC was
discovered in England and has since then been detected
in six more countries: DE, DK, FR, IE, NL, PT. [2]
Although the examined strains show phenotypical
methicillin resistance, it could not be detected with PCR
tests currently on the market. [3,4,5,8]
GENSPEED ®
MRSA is the first commercially available
test, which detects both methicillin resistance genes –
mecA and mecC.
Electronic evaluation of measurement data guarantees objective results.
The test system can be individually connected to your LIMS* if needed.
* laboratory information management system
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Components of the GENSPEED ®
MRSA Test System
The GENSPEED ®
Reader
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The GENSPEED ®
MRSA Test-Chip
• facilitates rapid testing by special microfluidics
for accelerated hybridization
• contains DNA probes for
• S.aureus
• S.epidermidis/haemolyticus
• the resistance genes mecA and mecC
In order to offer optimal ease of use, the Reader features:
• power supply and control via USB
• an integrated calibrator
• an integrated barcode module for
identifying the Test-Chip
• patented optoelectronics for
highly sensitive detection
as well as three on-chip controls to assure the MRSA test results.
* The PCR-Cycler
Accessories
The Notebook with integrated
GENSPEED ®
Report Software
• controls the GENSPEED ®
Reader
• offers intuitive user guidance through
test procedure
• analyses measurement data
• creates individualised reports
• allows optional connection to the LIMS
• 2 fixed volume pipettes
• 2 tube racks
• 1 box GBO filter tips
Swabs are not provided by Greiner Bio-One as a system component.
We recommend “108C Amies Agar Gel - Single plastic swab - blue cap”
These swabs can be used additionally after PCR for bacterial culture.
www.copaninnovation.com.
*
* symbolic photo

Full Speed - just a view steps to a reliable test result
DNA amplification
1
After successful sample
collection by means of nasal
or pharyngeal swab, the DNA
is released from the cells and
amplified for the subsequent
detection via PCR.
Item Nº Description Packaging
453200 GENSPEED ®
MRSA Test-Kit 48 rxn.
References
GENSPEED ®
(1) Medizinische Wirksamkeit und Kosten-Effektivität von Präventions- und Kontrollmaßnahmen gegen Methicillin-resistente Staphylococcus aureus (MRSA) –
Infektionen im Krankenhaus, HTA Bericht 100; DIMDI (Deutsches Institut für Medizinische Dokumentation und Information)
(2) November 2011 EURL course DTU Food, Technical University of Denmark (EURL=European Union Reference Laboratory) - Antimicrobial Resistance National Food
Institute
(3) Holmes MA, Zadoks RN. Methicillin Resistant S.aureus in Human and Bovine Mastitis. J Mammary Gland Biol Neoplasia. 2011 Oct 8. [Epub ahead of print]
(4) García-Álvarez L, Holden MT, Lindsay H, Webb CR, Brown DF, Curran MD, Walpole E, Brooks K, Pickard DJ, Teale C, Parkhill J, Bentley SD, Edwards GF, Girvan
EK, Kearns AM, Pichon B, Hill RL, Larsen AR, Skov RL, Peacock SJ, Maskell DJ, Holmes MA. Meticillin-resistant Staphylococcus aureus with a novel mecA
homologue in human and bovine populations in the UK and Denmark: a descriptive study. Lancet Infect Dis. 2011 Aug;11(8):595-603.
(5) Shore AC, Deasy EC, Slickers P, Brennan G, O‘Connell B, Monecke S, Ehricht R, Coleman DC. Detection of staphylococcal cassette chromosome mec type XI
carrying highly divergent mecA, mecI, mecR1, blaZ, and ccr genes in human clinical isolates of clonal complex 130 methicillin-resistant Staphylococcus aureus.
Antimicrob Agents Chemother. 2011 Aug;55(8):3765-73.
(6) The Lancet Infectious Diseases, Volume 11, Issue 8, Pages 595 - 603, August 2011 Background
(7) http://www.fennerlabor.de/uploads/media/MRSA.pdf
Hybridization
Article Overview GENSPEED ®
MRSA Test System
2
The PCR products are then
denatured and pipetted into
the Test-Chip inlet, where
hybridization takes place.
(Binding of the labelled DNA to the
complementary probes in the Test-Chip)
MRSA Starter Package
Detection & Reporting
The detection takes place via
optoelectronic readout of a
biochemical light reaction in the
GENSPEED ®
Reader.
The GENSPEED ®
Report
Software analyses the data and
generates the test report.
453201 GENSPEED ®
Reader 1 pc.
453203 PCR-Cycler 1 pc.
453204 Notebook (including GENSPEED ®
Report Software) 1 pc.
453205 Accessories 1 pc.
(8) Cuny C, Layer F, Strommenger B, Witte W. Rare Occurrence of methicillin-Resistant Staphylococcus aureus CC130 with a novel mecA homologue in humans in
Germany, PLoS One. 2011;6(9):e24360
3
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For further information, please visit our website www.gbo.com or contact us:
Austria (Main Office)
Greiner Bio-One GmbH
Phone (+43) 75 83 67 91-0
Fax (+43) 75 83 63 18
E-Mail office@at.gbo.com
Austria
Lambda GmbH
Phone (+43) 7949 2090 3000
Fax (+43) 7949 2090 3001
Brazil
Greiner Bio-One Brasil
Phone (+55) 19 34 68 96 00
Fax (+55) 19 34 68 96 21
E-Mail office@br.gbo.com
China
Greiner Bio-One Suns Co., Ltd.
Phone (+86) 10 83 55 19 91
Fax (+86) 10 63 56 69 00
E-Mail office@cn.gbo.com
Egypt
Greiner Bio-One Middle East
Phone (+20) 26 21 87 06
Fax (+20) 26 21 87 08
E-Mail hisham.ouda@gbo.com
France
Greiner Bio-One SAS
Phone (+33) 1 69 86 25 50
Fax (+33) 1 69 86 25 36
E-Mail office@fr.gbo.com
Hungary
Greiner Bio-One Hungary Kft.
Phone (+36) 96 21 30 88
Fax (+36) 96 21 31 98
E-Mail office@hu.gbo.com
India
Greiner Bio-One India Pvt. Ltd.
Phone (+91) 120 456 8787
Fax (+91) 120 456 8788
E-Mail info@gboindia.com
MRSA ?
Netherlands
Greiner Bio-One B.V.
Phone (+31) 1 72 42 09 00
Fax (+31) 1 72 44 38 01
E-Mail info@nl.gbo.com
Spain
VACUETTE Espana S.A.
Phone (+34) 91 652 77 07
Fax (+34) 91 652 33 35
E-Mail info@vacuette.es
Switzerland
Greiner Bio-One VACUETTE
Schweiz GmbH
Phone (+41) 7 12 28 55 22
Fax (+41) 7 12 28 55 21
E-Mail office@ch.gbo.com
Thailand
Greiner Bio-One Thailand Ltd
Phone (+66) 3 84 65 63-30
Fax (+66) 3 84 65 63-6
E-Mail office@th.gbo.com
= 75min
United Kingdom
Greiner Bio-One Ltd.
Phone (+44) 14 53 82 52 55
Fax (+44) 14 53 82 62 66
E-Mail info@uk.gbo.com
Distribution in the following countries is
carried out by Amplex Biosystems:
DE, IT, BE, PT, SI, TR, GR
E-Mail office@lambda.at Amplex BioSystems GmbH
Phone (+49) 8073 916 93 50
Fax (+49) 8073 916 93 55
E-Mail info@amplexbiosystems.de
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