MRSA? = 75min. GENSPEED MRSA Test System. Setting the pace - Precise MRSA results within 75 minutes.

Transcription

1 MRSA? = 75min GENSPEED MRSA Test System Setting the pace - Precise MRSA results within 75 minutes in cooperation with Amplex Diagnostics

2 GENSPEED MRSA Test System 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. 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. 2

3 Sensitivity owing to PCR technology, combined with the speed and specificity of the GENSPEED Test System - ready to use with a short turnaround time! With an average 7-day prolongation and additional expenses of 1,600.- Euro per patient / day, 1 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 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 75 Min 3. Detection & Reporting 69 Min 2. Denaturation & Hybridization 65 Min Lysis & DNA amplification 3

4 The advantages of the GENSPEED MRSA Test System Fast turnaround time (TAT) Speed 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 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 Differential diagnostics 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. 4

5 No false positive results due to Empty Cassette Variants and no false negative results due to the neglect of the new resistance gene mecc 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. 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. Technical advantages at a glance Easy handling Objective results Optional interfacing with your LIMS* Electronic evaluation of measurement data guarantees objective results. The test system can be individually connected to your LIMS* if needed. * laboratory information management system 5

6 Components of the GENSPEED MRSA Test System 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 as well as three on-chip controls to assure the MRSA test results. * The GENSPEED Reader 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 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 * The PCR-Cycler Accessories 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. 6 * symbolic photo

7 Full Speed - just a view steps to a reliable test result DNA amplification Hybridization Detection & Reporting 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. 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) 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. Article Overview GENSPEED MRSA Test System Item Nº Description Packaging GENSPEED MRSA Test-Kit 48 rxn. GENSPEED MRSA Starter Package GENSPEED Reader 1 pc PCR-Cycler 1 pc Notebook (including GENSPEED Report Software) 1 pc Accessories 1 pc. References 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 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 Aug;11(8): 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 Aug;55(8): The Lancet Infectious Diseases, Volume 11, Issue 8, Pages , August 2011 Background 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):e

8 MRSA? = 75min For further information, please visit our website or contact us: Austria (Main Office) Greiner Bio-One GmbH Phone (+43) Fax (+43) office@at.gbo.com Egypt Greiner Bio-One Middle East Phone (+20) Fax (+20) hisham.ouda@gbo.com Netherlands Greiner Bio-One B.V. Phone (+31) Fax (+31) info@nl.gbo.com United Kingdom Greiner Bio-One Ltd. Phone (+44) Fax (+44) info@uk.gbo.com Austria Lambda GmbH Phone (+43) Fax (+43) office@lambda.at Brazil Greiner Bio-One Brasil Phone (+55) Fax (+55) office@br.gbo.com China Greiner Bio-One Suns Co., Ltd. Phone (+86) Fax (+86) office@cn.gbo.com France Greiner Bio-One SAS Phone (+33) Fax (+33) office@fr.gbo.com Hungary Greiner Bio-One Hungary Kft. Phone (+36) Fax (+36) office@hu.gbo.com India Greiner Bio-One India Pvt. Ltd. Phone (+91) Fax (+91) info@gboindia.com Spain VACUETTE Espana S.A. Phone (+34) Fax (+34) info@vacuette.es Switzerland Greiner Bio-One VACUETTE Schweiz GmbH Phone (+41) Fax (+41) office@ch.gbo.com Thailand Greiner Bio-One Thailand Ltd Phone (+66) Fax (+66) office@th.gbo.com Distribution in the following countries is carried out by Amplex Biosystems: BE, DE, GR, IT, PT, SI, TR Amplex BioSystems GmbH Phone (+49) Fax (+49) info@amplexbiosystems.de rev.01, e