What is it? Sherlock knows! Microbial Identification System

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1 What is it? Sherlock knows! Microbial Identification System

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3 Sherlock Microbial Identification System Microbial ID 10 Minutes... $2.50 Is it accurate? Established technology with 15 years of clinical and environmental use. CDC method for Aerobic Bacteria ID (NIOSH Method# 0801). FDA 510(k) cleared for Anthrax ID [510(k) # k052485]. US Department of Homeland Security method for Anthrax ID (AOAC Method# ). Identifies all six major bioterrorism bacteria. How does it work? The Sherlock Microbial Identification System identifies bacteria and yeast based on GC profiles of extracted microbial fatty acid methyl esters (GC- FAME), unique for each species, which are matched to searchable libraries created from reference strains grown under standardized conditions. Libraries: Yeast species. Anaerobic Bacteria species. Aerobic Bacteria environmental species and 430 clinical species. Features: Rapid extract-to-id in minutes. Easy-to-use automated analysis and naming. Analyze up to 200 samples a day. Standardized procedure for all bacteria with no biochemical cards or offline tests. Microbes are killed during sample preparation. Comprehensive data analysis tools including clustering, dendrogram, data export and strain tracking. Enables FDA 21CFR Part 11- Electronic Records and Signatures compliance. Validation package available. Info Quantum Analytics 363 Vintage Park Drive Foster City, CA LQA@LQA.com

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5 The MIDI Sherlock Microbial Identification System Rapid Microbiology for the 21 st Century Overview For over 15 years, clinical and environmental customers have relied on the automated Sherlock Microbial Identification System as a rapid solution for the identification of bacteria and yeast. The Sherlock System represents a rapid, accurate and comprehensive solution for the identification of over 1,500 microbial species, including the 6 major bacterial agents of bioterrorism classified by the U.S. Centers for Disease Control (CDC). What makes the Sherlock System unique is that all microbes are analyzed using the same procedure with no offline tests, gram stains or biochemical cards required. Technology More than 300 fatty acids and related compounds have been found in the microbial cell membrane. The Sherlock System identifies microbes based on gas chromatographic (GC) analysis of extracted microbial fatty acid methyl esters (FAMEs). Microbial fatty acid profiles (fingerprints) are very unique from one species to another, and this fact has enabled MIDI to create large microbial libraries, as well as tools for tracking samples against tens of thousands of previous runs. Sophisticated pattern recognition algorithms are used to match the unknown microbial FAME fingerprints to the Sherlock libraries. Sherlock software automates all analytical operations. New in Sherlock System adds DNA Sequencing Capabilities Beginning in 2006, MIDI has incorporated DNA Sequence analysis into the Sherlock System. As a result, Sherlock users will be able to increase the number of microbial species they can identify from 1,500 (current FAME system) to over 2,500 microbial species by a combination of 16S (bacteria) and 28S (fungi/yeast) rrna sequence analysis, in addition to the standard FAME approach. The addition of DNA Sequencing will allow Sherlock users to create combined phenotypic (FAME) genotypic (DNA Sequencing) reports, the first of any automated microbial identification system on the market. The addition of DNA Sequencing technology to the Sherlock platform represents MIDI s continued pursuit to develop the most accurate and advanced microbial identification system in the industry. Proven Accuracy The Sherlock System is an established microbial identification technology with proven accuracy over a wide range of microbes. The Sherlock System has over 600 peer-reviewed journal articles to its credit and is a CDC Official Method for identification of aerobic bacteria. For confirmation of Bacillus anthracis (the anthrax pathogen), the Sherlock System has 2 distinctions: it is the only system that is cleared by both the U.S. Department of Homeland Security and U.S. FDA for B. anthracis confirmation. Key Benefits of the Sherlock System POLYPHASIC Identification by FAME and DNA technologies. RAPID FAME extract to identification in under 10 minutes. AUTOMATED Easy-to-use with no GC experience required. COMPREHENSIVE FAME and DNA libraries contain over 2,500 microbial species. STANDARDIZED Sample preparation is the same for all microbes. INEXPENSIVE Low-cost consumables with no biochemical cards. PRODUCTIVE Strain tracking, data export and analysis tools. SAFETY Microbe is killed during the first preparation step. COMPLIANCE Timesaving validation package and Support for 21CFR Part 11. MIDI Inc Sandy Drive Newark, DE USA sales@midi-inc.com

6 Sherlock 6.0 Microbial Identification System Specification Sheet General Description The Sherlock Microbial Identification System identifies bacteria and yeast by gas chromatographic (GC) analysis of fatty acid methyl esters (GC-FAME). The Sherlock software, methods and libraries are combined with an Agilent Technologies 6890 or 6850 GC and Agilent ChemStation software for a complete automated microbial identification solution. Sherlock s pattern recognition algorithms, combined with its calibration mixture, standardize each instrument. This virtually eliminates the manual calibration adjustments associated with a GC. No chromatography knowledge or experience is required. Microbe Libraries Sherlock methods and libraries are available for the following applications. Environmental Aerobes The environmental library contains 695 species. The standard culturing media used is TSBA. The standard incubation is 28 o C for 24 hours. Clinical Aerobes The clinical library contains 430 species. Blood agar is the standard culturing media. The standard incubation is 35 o C for 24 hours. Anaerobes Two anaerobe libraries are available. One is for BHIBLA plate-grown anaerobes (135 species). The other is for PYG broth-grown anaerobes (590 species). Yeast The yeast library has entries for 190 species grown at 28 o C on Sabouraud Dextrose Agar for 24 hours. Bioterrorism/Biowarfare This library identifies 6 major bacterial agents of bioterrorism/ biowarfare, plus 30 closely related species. Combined with the Clinical Aerobe library, the Bioterrorism library is a powerful tool for confirming bacterial threat agents (Developed with the U.S. Army Medical Research Institute for Infectious Diseases, USAMRIID, Fort Detrick, MD). Low Costs Per Sample It costs under $3.00 USD per sample for all consumables. This includes reagents, gases, calibration standards, glassware, and culture media. Instrument Throughput Following a short preparation procedure (typically done in batches), the sample vials are loaded into the instrument s autosampler. The automated system takes over and quickly analyzes each sample. No additional incubation is needed at this point. Standard methods process 2 samples per hour on single channel instruments and 4 samples per hour on dual channel instruments. Rapid methods for Environmental Aerobes, Clinical Aerobes and Bioterrorism bacteria process 6 samples per hour on a single channel and 12 samples per hour on a dual channel instrument. This method has 2 times the detection sensitivity of the Standard methods. Sensitive methods for Anaerobes and Yeasts process 2 samples on a single channel and 4 samples on a dual channel instrument per hour. This method has 2 times the detection sensitivity of the Standard methods, and uses the same calibration standard as Rapid methods. Culturing Like all widely used confirmatory techniques, Sherlock requires pure microbial cultures. Using standard laboratory techniques, a primary isolation plate is incubated for 24 hours for a typical sample. If the primary plate appears to be a single organism, a small cross-section of cells is harvested and incubated for 24 hours on a secondary plate. If the primary plate appears to be a mixed culture, a colony or each type may be subcultured. Slow growing organisms will require longer incubation times. MIDI, Inc. Newark, Delaware Sample Preparation Using inexpensive reagents, available from almost any chemical supply house, a technician averages only 5 minutes per sample to prepare a batch of 30 samples. Each sample is prepared for analysis using a liquidliquid extraction in a single test tube. Harvesting a small quantity of cells from the culture plate is the most labor-intensive step. It will typically take 1 hour or less to harvest cells from 30 plates into 30 test tubes. The four-step liquid-liquid extraction process requires about 1½ hours or less for a batch of 30 samples. During the extraction process, approximately 35 minutes of wait time are available for the technician to do paper work and other tasks. The same sample preparation is used on all samples. It is not necessary to do a Gram stain or other offline tests before preparing and analyzing a sample. Bio-Safety Bio-Safety is enhanced because live organisms are not introduced into the instrument. The first step of the extraction procedure treats the cells with a sodium hydroxide solution for 30 minutes in a 100 o C water bath. After the first step, the technician is no longer working with live organisms. Laboratories that handle dangerous pathogens will typically perform the sample extraction in a BSL-3 lab and transfer decontaminated extracts to a non BSL-3 lab for instrument analysis. This allows the instrument to be maintained and serviced by technicians outside the BSL-3 lab.

7 Instrumentation A Sherlock system is composed of a Windows XP or 2000 based computer loaded with the MIDI Sherlock software and an Agilent ChemStation. The computer is interfaced to one of the following instruments: Agilent 6850 GC with single column and a 27-vial autosampler. Agilent 6890 GC with a single column and a 100-vial autosampler. Agilent 6890 GC with dual columns and a 100-vial autosampler. Analysis Relationships between samples can be explored using: Dendrogram plots Neighbor-joining trees Principal component analysis (PCA) with 2-D plots and histograms The graphics can be exported to Microsoft Office and other packages for further analysis and for research publications. Custom Libraries Using the optional Library Generation System (LGS), custom libraries can be created from your samples. Uses for custom libraries: Quality control of proprietary strains used in production processes Quickly recognize contaminants that reoccur in a facility or process Assign an identity to organisms that do not have a published taxonomy Catalog culture collections Research Data Export Data Export software exports sample data, fatty acid profiles, library match results, and other information to Excel spreadsheets and Access databases. There are many applications for custom reports and calculations created using Excel, Access, and other data analysis tools: Trend analysis Custom reports Summary reports for sample sets Microbe population studies Research and publications Data mining Strain Tracking Tracker/Cluster is an optional strain tracking package. It is a powerful tool that helps locate the source of a contamination. Tracker locates other samples that are likely to be the same strain as a sample of interest. Tracker searches for strain matches between the current sample and all previous samples. Uses include: Trend analysis Summary reports for sample sets Microbe population studies Research and publications Data mining Cluster, is a new module that automatically finds groups (clusters) of highly related samples. Relationships between clusters and samples can be explored using: Dendrogram plots Neighbor-joining trees 2-D Color-coded PCA plots Tracker and Cluster operate independently of sample identification, allowing unknown samples to be compared. 21 CFR Part 11 The optional Electronic Records and Signatures (ERS) package can be added to support compliance with FDA regulation 21 CFR Part 11. Provides access control based on Windows XP or Windows 2000 user passwords and group settings to authenticate users and determine their privileges. When configured with a Windows XP or Windows 2000 domain, users can be authenticated using their domain credentials. Sherlock requires the user to logon before granting access to controls and data. Packages all associated data, audit trails, logs and results in a secure electronic vault for storage on the local disk or on a remote file server. Supports two levels of electronic signature authority with notes added by the signer. Automatic inactivity logoffs. Supports security policies defined for the Windows XP/2000 system or domain, including lockout of accounts after a predetermined number of login failures. Sherlock DNA Sherlock DNA is an optional package, which allows for identification and analysis of microbial DNA sequences. Sherlock DNA comes with 16S rrna gene sequence libraries for bacterial identification and an optional 28S rrna add-on for fungi/yeast identification. The system is not limited to a specific DNA product. Custom libraries can be created from your samples. In addition Sherlock DNA makes it possible to have a combined fatty acid- DNA sequence report for a polyphasic approach to identification. Markets Using Sherlock Animal Science Bioremediation Biodefense / Bioterrorism Clinical Diagnosis Dental Research Entomology Epidemiology Food Microbiology Marine Science Medical Research Pharmaceutical QC Plant Pathology Soil Science Water Quality Taxonomy Studies The information in this publication is subject to change without notice. MIDI & MIDI Authorized distributors are the sole source for the Sherlock Microbial Identification System. Copyright 2005 MIDI, Inc. All Rights Reserved Date: 20 December 2005 MIDI, Inc. 125 Sandy Drive Newark, Delaware Phone: Fax: sales@midi-inc.com

8 RENT Your Sherlock System Today! 12 month minimum rental includes: System software Installation Training Tech support Start-up kit Libraries of choice Any additional MIDI software requested LEASE Spread out payments 100% financing 12 to 60 month terms BUY Entire system can be purchased directly with a single purchase order. Tel: MIDI Inc. 125 Sandy Drive Newark, DE USA sales@midi-inc.com