MRSA results in hours, not days - 3M BacLite Rapid MRSA Test

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MRSA results in hours, not days - 3M BacLite Rapid MRSA Test
3M BacLite Rapid MRSA Test
  ™       ™

MRSA results in hours,
   not days
MRSA results in hours, not days - 3M BacLite Rapid MRSA Test
Rapid MRSA identification can
       help hospitals take control
Rapidly identifying         Methicillin-resistant Staphylococcus aureus (MRSA) is a leading cause of healthcare associated
                            infections worldwide. The need for rapid patient screening for MRSA as a component of infection
                            control measures to potentially improve outcomes in the colonised patient and prevent transmission
MRSA colonised patients
                            to other patients has been clearly established1.

provides hospitals with         • More than 53 million people worldwide carry MRSA2
                                • MRSA-related hospital stays average 12 additional days3
another tool to assist in       • MRSA-related infections cost an additional $27,000 - $34,000 to treat3,4
                                • Rapid screening may save up to 90% of isolation-associated costs5
proactively managing
                            New DNA-based tests, while fast, have proven cost-prohibitive for widespread use. Traditional

Health Care Associated      methods rely on time-consuming culture techniques which require 48 hours to exclude MRSA
                            and days to confirm positives. During this time, infection control measures, such as isolation and
                            antibiotics, may be applied unnecessarily.
Infections, which may
                            3MTM BacLiteTM Rapid MRSA Test allows fast, affordable
help to improve patient     screening of patients for MRSA – in hours, not days –
                            providing hospitals and clinicians with a valuable
outcomes and decrease       tool to help positively impact infection
                            control practices. The rapid result
treatment costs.            allows more effective use of
                            hospital isolation resources
                            while helping reduce
                            cross-contamination,
                            ultimately reducing
                            the time and costs
                            associated with MRSA.
MRSA results in hours, not days - 3M BacLite Rapid MRSA Test
The 3M™ BacLite™ MRSA Test                                     Infection prevention has taken a step forward with the application of adenylate kinase (AK) Rapid

accurately identifies MRSA –                                   technology for medical diagnostics. Through a simple test using familiar methodology, 3M BacLite
                                                               Rapid MRSA test is a qualitative assay for the detection of MRSA from nasal and groin swabs. The
in hours, not days
                                                               BacLite Rapid MRSA test gives hospitals a tool to easily and affordably determine which patients
 • Qualitative negative result                                 are most at risk due to MRSA colonisation, allowing hospitals to streamline laboratory workflow,
    in five hours                                              reduce costs associated with unnecessary isolations and improve management of microbial
                                                               infections – potentially improving patient outcomes and mitigating risk of cross-contamination.
 • Proprietary AK Rapid ®
    technology delivers                                        45 minutes total hands-on time for 43 direct from patient specimens
    reliable results                                              1. Screening swabs are collected from patients using standard hospital procedures
                                                                  2. Dispense pre-warmed & supplemented broth into Bijou, add swab and vortex
 • Diagnostic sensitivity                                         3. Prepare processor and reader
    of 94.6% for MRSA                                             4. Dispense capture reagent and sample into microtitre plate and wash in the processor
    nasal detection *                                             5. Add controls and read

 • Diagnostic specificity                                      3M BacLite Rapid MRSA Test kit components
    of 96.9% for MRSA                                             • Reagent Pack
    nasal detection *                                             • Supplement Pack
                                                                  • Broth Pack
 • Negative predictive
                                                                  • Microtitre Plates
    value of 99.9% for MRSA
    nasal detection *

Conventional broth based microbiology techniques with AK bioluminescence end point detection

                        Selective                                         Extraction                        Selective                      Read
                       Enrichment                                         & Growth                            Lysis

*Refer to BacLite Rapid MRSA test package insert for detailed product information.
MRSA results in hours, not days - 3M BacLite Rapid MRSA Test
Through an easy-to-run test                                  A powerful new tool in the prevention and control of healthcare
– 45 minutes total hands-on                                  associated infections.
time for 43 direct from patient                              Designed to provide hospital staff with rapid, reliable diagnostic information, the 3M BacLite Rapid
                                                             MRSA Test is a highly sensitive test that delivers a negative predictive value of 99.9% for MRSA
specimens – the 3M™ BacLite™
                                                             nasal detection in just 5 hours.*
Rapid MRSA Test pinpoints
patients at increased risk due to                            The 3M BacLite Rapid MRSA Test utilises highly sensitive AK technology:
colonisation.                                                     • Unique test measures adenylate kinase activity
                                                                  • Highly affordable compared to the costs associated with molecular methods
The 3M BacLite system consists                                    • Easy to use with minimal training required
of a Reader, Processor, Computer,
                                                             Adenylate kinase, an essential housekeeping enzyme found in all cells, is used as an ultra
Printer and Barcode Scanner.
                                                             sensitive cell marker. AK regulates energy provision by catalysing the equilibrium reaction: ATP
• Highly sensitive rapid culture                             + AMP  2ADP. By supplying purified ADP in vitro, the amplified levels of ATP produced can be
    based screening test                                     measured using bioluminescence.

• Results direct from specimen                               This amplification means that AK Rapid technology is up to 100 times more sensitive than
                                                             traditional ATP based systems. In addition, because AK levels within cells fluctuate less than ATP
• Automated end-point with
                                                             levels do, correlation of the AK assay with cell numbers is more accurate than that given by direct
    objective results
                                                             ATP-based measurements.
• Barcode for effective sample
    tracking                                                 This approach retains the benefits of traditional culture-based methodologies, including ease of
                                                             use, but provides a result more sensitive than traditional optical techniques in just 5 hours and
• Easily expanded to run                                     without the high cost associated with DNA-based methods. This allows hospitals to affordably
    additional BacLite tests                                 implement screening to help optimize patient outcomes and mitigate the risks associated with
                                                             cross-contamination.

*Refer to BacLite Rapid MRSA test package insert for detailed product information.
MRSA results in hours, not days - 3M BacLite Rapid MRSA Test
3M™ BacLite™ Rapid MRSA Test
Fast Turnaround
    • Confirmed negative in just 5 hours; confirmed positive next day

    • Easy to implement as part of pre-admittance

Easy to use
    • Swab used for specimen collections

    • Minimal training required to run test

    • Automatic interpretation of results

Highly Sensitive AK Rapid Technology
      • Detects only viable organisms

      • Bioluminescence combined with stable adenylate kinase

         for fast, accurate results

          Nasal Swabs - Diagnostic Sensitivity
                   and Specificity*
           Sensitivity                             94.6%
           Specificity                             96.9%
               NPV                                 99.9%

          Groin Swabs - Diagnostic Sensitivity
                   and Specificity*
           Sensitivity                             95.9%
           Specificity                             88.8%
               NPV                                 99.9%

* Refer to the 3M BacLite Rapid MRSA test package insert for detailed
  product information.
MRSA results in hours, not days - 3M BacLite Rapid MRSA Test
Order Code 		                                 Product 		                                                Description

                           GH620500310 3M™ BacLite™ Flex System                                                        Reader, Processor, PC, Monitor, Printer,
                           					                                                                                       Bar Code Scanner and Accessories

                             DH999995672                  3M™ BacLite™ MRSA Sample Swabs                               Box of 125 Swabs

                           GH620500328                    3M™ BacLite™ Rapid MRSA+                                     1 Set of Test Reagents
                           			                            Pack 1: Test Reagents

                           GH620500336                    3M™ BacLite™ Rapid MRSA+                                     10 Sets of Broth Supplements
                           			                            Pack 2: Broth Supplements

                           GH620500344                    3M™ BacLite™ Rapid MRSA+                                     10 Bottles of Broth
                           			                            Pack 3: Broth

                           GH620500351                    3M™ BacLite™ Rapid MRSA+                                     10 Microtitre Plates and Seals
                           			                            Pack 4: Microtitre Plates and Seals

                           References:
                           1 Salgado CD, Farr BM. “What proportion of hospital patients colonized with methicillin-resistant Staphylococcus aureus are identified by clinical microbiological cultures.”
                             Infect Control Hosp Epidemiol. 2006;27:116–21
                           2 Okuma K. “Dissemination of new methicillin-resistant Staphylococcus aureus clones in the community”. J Clin Microbiol 40 (11): 4289-94. PMID 12409412
                           3 Abramson MS. Infect Control Hosp Epidemiol. 1999; 20: 408-11
                           4 “New Research Estimates MRSA Infections Cost U.S. Hospitals $3.2 Billion to $4.2 Billion Annually” Study conducted by U.S. Outcomes Research Group, Pfizer, Inc.,
                             Abstract # 9489
                           5 Bootsma MCJ, et al. “Controlling methicillin-resistant Staphylococcus aureus: Quantifying the effects of interventions and rapid diagnostic testing.” Proceedings of the
                             National Academy of Sciences of the United States of America. 2006; 103: 5620-5625

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3M Medical Diagnostics
3M Health Care Limited		                                      3M Ireland
3M House                                                      3M House
Morley Street                                                 Adelphi Centre                                                 © 3M 2007
Loughborough                                                  Dun Laoghaire                                                  3M and BacLite are trademarks of 3M or Acolyte Biomedica Ltd.
Leicestershire LE11 1EP                                       Co Dublin                                                      AK Rapid is a registered trademark of Defense Science and
Phone: 01509 611611                                           Ireland                                                        Technology Laboratory.
Fax: 01509 237288                                             Phone: (01) 280 3555                                           Date of preparation: November 2007.
Web: www.3m.co.uk/medicaldiagnostics                          Fax: (01) 280 3509                                             GW001
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