The MIDI Sherlock® Microbial Identification System Rapid Microbiology for the 21st 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 2006- 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. 800-276-8068 125 Sandy Drive Newark, DE 19713 USA sales@midi-inc.com

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 28o C for 24 hours.

Clinical Aerobes The clinical library contains 430 species. Blood agar is the standard culturing media. The standard incubation is 35o C for 24 hours.

AnaerobesTwo 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 28o 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 Standardmethods, and uses the same calibration standard as Rapidmethods.

CulturingLike 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.

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 liquid-liquid 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 100o 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.

MIDI, Inc. Newark, Delaware

InstrumentationA 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 trees2-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 anoptional 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

www.midi-inc.comThe 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 19713 Phone: 302-737-4297 Fax: 302-737-7781 Email: sales@midi-inc.com

GRAM(+) Cocci Fastidious Gram(-) Rods Micrococcus spp. Actinobacillus spp. Staphylococcus spp. (clinical only) Bartonella spp. Streptococcus spp. Brucella spp. Capnocytophaga spp. GRAM(+) Rods Cardiobacterium spp. Chromobacterium spp. Bacillus spp. Eikenella spp. Gordonia spp. Francisella spp. Nocardia spp. Kingella spp. Rhodococcus spp. Legionella spp. Streptomyces (genus only) Streptobacillus spp. Other Actinomycetes Suttonella spp. Yersinia spp. Nonfermentative Gram(-) Rods Anaerobic Bacteria Achromobacter spp. Acinetobacter spp. Gram(+) and Gram(-) anaerobes Alcaligenes spp. Brevundimonas spp. Biothreat Agents Burkholderia spp. Comamonas spp. Bacillus anthracis (Anthrax) Methylobacterium (genus only) Brucella melitensis (Brucellosis) Moraxella spp. Burkholderia mallei (Glanders) Pseudomonas spp. Burkholderia pseudomallei (Melioidosis) Ralstonia spp. Francisella tularensis (Tularemia) Stenotrophomonas spp. Yersinia pestis (Plague) Other Nonfermentative Gram(-) Rods

Sherlock® Microbial Identification System (MIS) Major Bacterial Species the MIDI System Identifies Environmental and Clinical Markets

Sherlock Rapid Methods The Same Results 3x Faster

Fact Sheet

General Description Rapid methods with corresponding libraries (databases) get the same results three times faster than their standard method counterparts. Rapid methods are 2.5 times more sensitive, reducing the number of cells needed for the analysis.

AdvantagesSame day identification of isolates Samples requiring reanalysis can be processed immediately Fewer cells used for analysis reduces culturing time for slow growing organisms Easier harvesting of cells for analysis reduces labor Reduced injection port maintenance due to less material being injected Improved results for organisms containing mycolic acids

Rapid Chromatography The rapid methods take advantage of the advanced electronic flow control features of the Agilent 6890 and 6850 gas chromatographs to obtain the same results using the same GC column in a fraction of the time.

Figure 1 shows the chromatogram and Sherlock library search results for a Bacillus subtilis analyzed with the standard chromatographic method. Identical results are obtained much faster using the rapid method (figure 2). The two chromatograms are nearly identical except for the different time scales. The peak that elutes at 13.571 minutes using the standard method elutes at 3.433 minutes using the rapid method. The analytical run is 3.9 times faster. The total throughput, which includes the time for the GC to prepare for the next run, is approximately 3 times faster.

System Requirements The rapid methods will not work with the 5890 GC or older versions of Sherlock. The following are required:

Agilent 6890 or 6850 GC Sherlock version 4.5 or higher

m2 4 6 8 10 12 14 16

pA

4

5

6

7

8

FID1 A, (A0132085.D)

1.5

62

2.8

86

4.1

63 6.4

70 6

.976

7.9

16 8

.052

9.1

16 9

.509

9.7

24 1

0.12

1

10.

784

10.

936

11.

196

11.

356

13.

571

Matches:

Library Sim Index Entry Name TSBA50 5.00 0.938 Bacillus-subtilis 0.577 Bacillus-atrophaeus

Figure 1- Standard Method for a B. subtilis sample

m0.5 1 1.5 2 2.5 3 3.5 4

pA

4

6

8

10

12

14

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*FID1 A, (A0042025.D)

0.7

23

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79

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72 2

.180

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.402

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17 2

.686

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34 2

.802

2.9

33 2

.963

3.0

03 3

.034

3.4

33

Matches:

Library Sim Index Entry Name RTSB50 5.00 0.938 Bacillus-subtilis 0.582 Bacillus-atrophaeus

Figure 2- Rapid Method for the Same B. subtilis

Rapid Libraries When the same sample is analyzed with both the Rapid and Standard methods, the match results for the Rapid library are nearly identical to those for the Standard library. The Rapid libraries were generated from the same data as the Standard libraries.

The Rapid methods and libraries improve results for organisms, containing mycolic acids. Cleavage of mycolic acid side chains may result in fragments being randomly named as fatty acids by the Standard methods. Chromatography improvements let the Rapid method and library mostly ignore these fragments.

Calibration Standard With the increased sensitivity, the Rapid methods require a new calibration standard. The Rapid Method Calibration Mix (MIDI part no. 1300-A) is packaged in distinctive brown glass ampoules.

Compatibility The Rapid methods use the same analytical column as the standard methods. This allows one instrument to run both Rapid and standard methods.

Standard method samples can be mixed, in the same sequence, with Rapid method samples. The electronic pressure and flow control of the 6890 and 6850 allow Sherlock to establish the correct operating conditions for each method.

ValidationMIDI followed in-house procedures to validate the Rapid methods and libraries. The Rapid methods and libraries ship with a certificate of validation. Validation documents are available for inspection at MIDI’s office in Newark, Delaware.

OperationHarvest only ca. 20mg wet weight of cells (2 to 2.5 times less than the 40 to 50mg for the standard method). Fewer cells should be used to avoid overloading the more sensitive GC analysis.

The remainder of the sample preparation procedure is identical to the standard method. The same reagent volumes, reaction temperatures, and times are used.

Enter the calibration mix and samples into the Sherlock Sequencer’s sample table. Select the appropriate Rapid Method (RTSB50, RCLN50, or RBTR50) rather than one of the standard methods.

Samples using standard methods (e.g. the Moore anaerobe method), with their calibration standards, can be entered in the same sequence.

The analytical speed allows time during the workday for operators to review results and reanalyze samples that require dilution or concentration.

Available Methods Rapid methods are currently available for the following applications:

Environmental AerobesThe environmental library contains 690+ species. The standard culturing media used is TSBA. The standard incubation is 28o C for 24 hours.

Clinical Aerobes The clinical library contains 410+ species. Blood agar is the standard culturing media. The standard incubation is 35o C for 24 hours.

Bioterrorism This library identifies the 6 major bacterial agents of bioterrorism plus another 15 closely related organisms. Combined with the Clinical Aerobe library, the Bioterrorism library is a powerful tool for confirming a biological attack. (Developed with the U.S.Army Medical Research Institute of Infectious Diseases, Fort Detrick, MD, the Bioterrorism library is available free of charge to qualified owners of a MIDI Sherlock system.)

www.midi-inc.comThe information in this publication is subject tochange without notice.

Copyright 2002 MIDI, Inc. All Rights Reserved Date: 31 October 2002

MIDI, Inc. 125 Sandy Drive Newark, Delaware 19713 Phone: 302-737-4297 Fax: 302-737-7781 Email: midi@midi-inc.com

MIDI, Inc. Newark, Delaware

Sherlock® Tracker/ClusterStrain Epidemiology With Real-Time Results

Where and When haveI seen this bacteria before?

Tracker Fact Sheet

Create your own data sets to track against

Track strains quickly and easily-even

unknowns

Scan thousands of samples automatically

for closest matches

No prior knowledge of the sample is required

Track samples automatically after each run or in offline mode

Detect contaminants and identify nosocomial

outbreaks faster

Tracker Example

In Figure 1, Tracker was used “in house” to compare the strain of anthrax found in Connecticut to MIDI’s BIOTER1.0 library anthrax entries. The strain matched with the Ames strain at a Cutoff Factor of 3.000, indicating the same strain.

Figure 1- Tracking Anthrax in the Connecticut Case- Data courtesy of the Connecticut Department of Public Health Laboratory

DescriptionMIDI Inc.’s Sherlock® Microbial Identification System (MIS) has provided strain tracking as a manual capability of Sherlock’s advanced Library Generation Software (See Technical Note #102). Sherlock Tracker is an add-on module for the Sherlock 4.5 and 6.0 versions that enhances Sherlock’s strain-tracking ability.

Tracker automatically compares the cellular fatty acid profile of a sample to a database of previously analyzed samples. A report is generated of the samples that are most similar. Tracker can track samples, whether or not the samples match known bacterial species in MIDI’s extensive libraries. Comparisons can also be made automatically after each sample run, so that you will know immediately if you have seen the sample before.

Database CreationWith a few mouse clicks, the user can build a Tracker database. Data from Sherlock samples, even samples run on previous versions of Sherlock, may be quickly combined to create a Tracker database for searching. New samples may be automatically added to the database as Sherlock runs them.

Online Tracker ReportsTracker may be configured to automatically generate reports as each Sherlock sample completes.

Offline Investigation with TrackerUsing the Tracker mode in Sherlock’s CommandCenter, samples may be evaluated against Tracker databases, and new reports generated.

MatchInquiry

MIDI, Inc125 Sandy Drive Newark DE 19713(302) 737-4297sales@midi-inc.com

Introducing ClusterCluster Fact Sheet

DescriptionCluster is a new analytical tool available in Sherlock 6.0 with the Tracker option. Cluster automatically creates groups of similar samples. Two separate clustering algorithms are used allowing the user to easily create clusters and determine the relationship between these clusters.

Uses

Quality Control trending and tracking.In some cases a particular type of bacteria is seen consistently within a pharmaceutical process. Clustering allows identification of samples that fall into the group; Samples that fail to match the group may indicate a change in the pharmaceutical process.

Identification of new bacterial species.A cluster of closely related samples may indicate the existence of a new species. These samples can form the backbone for delineating the new species.

Location of unexpected patterns in data.A cluster may contain a wholly unanticipated connection among samples, such as day of week, time of year, or processing technician. Once the cluster has been defined, the analyst can evaluate the associated samples to identify such patterns.

Figure 2 - Cluster Detail View

Figure 3 - Principle Component Plot of Largest Clusters

Sherlock® Tracker/ClusterStrain Epidemiology With Real-Time Results

MIDI, Inc125 Sandy Drive Newark DE 19713(302) 737-4297sales@midi-inc.com

Export Sherlock data to spreadsheets and

databases with ease

Generate custom reports for your facility

or project

Automatically gather and monitor calibration

performance

Export 2-D plots to spreadsheets for

publication purposes

Automatically monitor injection port liner and column performance to

minimize downtime

DescriptionSherlock Data Export is an optional extension to MIDI Inc.’s Sherlock®

Microbial Identification System (MIS). Data Export can be used to export Sherlock information to a database or a spreadsheet. Once the information is exported to these industry-standard files, an array of analysis, reporting and charting tools may be used.

Data Export creates Microsoft Access® databases and Excel® spreadsheets. Microsoft Office® is not required to use Data Export- many packages accept databases and spreadsheets in these formats- however, to get the full value from Data Export, Microsoft Office is suggested.

Customized ReportsData Export allows the Sherlock user to make customized reports, especially with the use of Excel and Access programs. Examples of customized reports (Figures 1-4) include: Calibration performance, hydroxyl fatty acid recoveries, best match reports and Similarity Index (SI) plots.

Sherlock® Data Export Advanced Sherlock Data Management

Fact Sheet

How do I create a customized report from my Sherlock identification data?

Figure 1- Sherlock Calibration Performance- this report gives a summary of calibration performance for each sequence run. Changes to the query and report could be made to report, for example, weekly calibrations instead of all sequences, or to include more or less information.

Hydroxyl Percentages

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Per

cent 10:0 2OH

16:0 2OHLow Percent

Hydroxyl Percentages

1.9

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cent 10:0 2OH

16:0 2OHLow Percent

Figure 2- Hydroxyl Fatty Acid Recoveries- the following chart shows percentages of 10:0 2OH and 16:0 2OH in calibration runs over time. In this case, the hydroxyl percentages stay above the cutoff of 2%. This type of report can be used to monitor injection port liner and column performance.

www.midi-inc.comThe information in this publication is subject to change without notice.

Copyright 2002 MIDI, Inc. All Rights Reserved Date: 03 November 2002

MIDI, Inc. 125 Sandy Drive Newark, Delaware 19713 Phone: 302-737-4297 Fax: 302-737-7781 Email: midi@midi-inc.com

MIDI, Inc. Newark, Delaware

Date ID_Nbr Samp_Id %Named Sim_Index Name

9/26/2001 10762 UN-MIDI-B-1(4343-01177 100.00 0.853 Bacillus-megaterium-GC subgroup

9/26/2001 10763 UN-MIDI-B-1(4345-01177 100.00 0.703 Micrococcus-luteus-GC subgroup

9/26/2001 10764 UN-MIDI-B-1(4349-01178 93.64 0.617 Brevibacterium-linens*

9/26/2001 10765 UN-MIDI-B-1(4357-01179 100.00 0.842 Bacillus-cereus-GC subgroup A*

9/26/2001 8627 UN-MIDI-A(2203-15604B 100.00 0.676 Acinetobacter-radioresistens

9/26/2001 8628 UN-MIDI-A(2204-15605 100.00 0.768 Acinetobacter-baumannii

9/26/2001 8629 UN-MIDI-A(2205-15619A 100.00 0.575 Acinetobacter-radioresistens

9/26/2001 8630 UN-MIDI-A(2206-15623A 99.08 0.924 Stenotrophomonas-maltophilia*

9/26/2001 8631 UN-MIDI-A(2207-15624F 99.43 0.756 Stenotrophomonas-maltophilia*

9/26/2001 8633 UN-MIDI-A(2209-15647 100.00 0.443 Paenibacillus-gordonae*

Date ID_Nbr Samp_Id %Named Sim_Index Name

9/26/2001 10762 UN-MIDI-B-1(4343-01177 100.00 0.853 Bacillus-megaterium-GC subgroup

9/26/2001 10763 UN-MIDI-B-1(4345-01177 100.00 0.703 Micrococcus-luteus-GC subgroup

9/26/2001 10764 UN-MIDI-B-1(4349-01178 93.64 0.617 Brevibacterium-linens*

9/26/2001 10765 UN-MIDI-B-1(4357-01179 100.00 0.842 Bacillus-cereus-GC subgroup A*

9/26/2001 8627 UN-MIDI-A(2203-15604B 100.00 0.676 Acinetobacter-radioresistens

9/26/2001 8628 UN-MIDI-A(2204-15605 100.00 0.768 Acinetobacter-baumannii

9/26/2001 8629 UN-MIDI-A(2205-15619A 100.00 0.575 Acinetobacter-radioresistens

9/26/2001 8630 UN-MIDI-A(2206-15623A 99.08 0.924 Stenotrophomonas-maltophilia*

9/26/2001 8631 UN-MIDI-A(2207-15624F 99.43 0.756 Stenotrophomonas-maltophilia*

9/26/2001 8633 UN-MIDI-A(2209-15647 100.00 0.443 Paenibacillus-gordonae*

Figure 3- Result Summaries- with Data Export, a report can be created that has one line per sample with specific information selected for that sample, such as the the “best match.”

Figure 4- Summary Statistics- in this example, a set of QC samples, all identified correctly as Stenotrophomonas maltophilia, is exported to Microsoft Excel using Data Export. The Similarity Index (SI) over time is plotted to look for any unusual trends.

FDA 21 CFR Part 11 compliant software

Data from each batch is stored in a

single, secure file

User authentication is required at key

operational points

Electronically sign each report and attach

comments

Create an audit trail of all entries and actions

on an ERS file

Regenerate original reports and view chromatograms

DescriptionSherlock Electronic Records and Signatures (ERS) is an optional extension to MIDI Inc.’s Sherlock® Microbial Identification System. Sherlock ERS permits controlled data access to authorized personnel. A core component to 21 CFR Part 11 compliance is the ability to link all related transactions to an electronic signature and to track any associated changes made to a secure file. Sherlock ERS preserves the data, methods, libraries and audit trail from a Sherlock sequence in a single, secure file.

The Sequence Audit Log details all of the actions taken while the sequence was run, showing the date, the user name and the activity. Changes after the data have been collected, such as approval or rejection of a sample, are detailed in the Audit Log, which also displays the date, name and associated action. The Audit Log shows the old and new values for each change.

SecurityIn order to comply with the FDA’s requirement that an electronic signature must employ at least two distinct identification components, such as a username and password, Sherlock ERS requires this information at every key operational point in the system. Sherlock ERS is integrated with the Windows® NT and 2000 security models. Authorized ERS users and passwords are determined by the local or network system administrator, depending on the environment that the Sherlock system is employed in.

Sherlock® ERSElectronic Records and Signatures

Fact Sheet

Is your Bacterial IdentificationSystem 21 CFR Part 11 Compliant?

ERS View Sherlock ERS permits review and verification of electronic records through a Windows®-based interface. Authorized users are able to view sample information, reports, chromatograms and audit logs. In addition, select changes can be made to ERS files, depending on the level of authority the user has.

Figure 1- Sherlock ERS View

www.midi-inc.comThe 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 19713 Phone: 302-737-4297 Fax: 302-737-7781 Email: sales@midi-inc.com