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THE POWER TO DO MORE BAX ® System Q7

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Page 1: THE POWER TO DO MORE - Global Headquarters · sacrificing the industry-leading accuracy that is synon ymous with the BAX ... and require no additional specialized skills. 20 21 Pre-measured,

T H E P O W E R T O D O M O R E™

BAX® System Q7

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Food companies around the world already rely on the

BAX® detection system from DuPont Qualicon for fast and accurate

pathogen testing.

With the new BAX® System Q7, DuPont Qualicon provides the food

industry with advanced testing technology–giving them the power

to do more.

The BAX® System Q7 provides the food industry with the precision,

flexibility and control it needs in a platform that most everyone can

operate with clear, definitive results.

Positive or negative.

Pass or fail.

With the power to do more, the answer is clear.

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The answer has never been clearer.

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We do more than test food.We test the limits of what isThe BAX® System Q7 is the result of that pursuit—

equipment, assays and software with breakthrough power

capable of revolutionizing the entire food industry.

possible.

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BAX® System PCRassays aredesigned to usethe chemistry thatbest meets specifictesting demands.

PCR amplifications aremeasured as theyoccur, cycle-by-cycle,allowing quantitativemeasurements to bemade. This saves timeand provides precisequantitation over alarge dynamic range.

The BAX® System pinpointsthe actual genetic structureof bacteria by detecting aunique DNA fragment foundonly in the target organism.

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The real benefit of real-time PCR.

The BAX® System is an automated DNA-based detection system

for pathogen and food quality testing, giving you precise

and accurate results with minimal hands-on time. It breaks down

samples at the genetic level, using the power of real-time PCR

to detect bacteria and other organisms. The unique genetic

signatures of pathogens can be detected rapidly with a high

level of certainty.

The next-generation BAX® System Q7, developed in alliance

with Applied Biosystems, now features real-time PCR capabilities,

which enable testing for multiple targets in a single sample,

shorter processing times, five-dye detection and faster results.

With real-time PCR technology, amplification is measured as

it occurs, allowing for the detection of sequence-specific PCR

products as they accumulate in "real time." As the fragments are

produced, the system determines both the presence and quantity

of a target. This has great value in food quality testing, where

product release decisions are often based on the concentration

level of the target.

Some BAX® System PCR assays use intercalating dye chemistry to

detect specific DNA fragments. The BAX® System Q7 expands that

use to include real-time PCR assays with probe-based chemistry.

Probes allow the system to distinguish separate species in a single

sample. Both of these methods provide comprehensive analysis

of samples, outstanding reliability and precise results.

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BAX® System Q7 probe-based chemistry.

PCR reaction tubes contain tablets that arehydrated with prepared test samples. Thesetablets contain highly specific probes,along with all the reagents, enzymes andprimers needed for the PCR reaction. Theprimers and probes match a unique geneticregion of the target's DNA. Their selectiondetermines the specificity of the assay.

The PCR process begins with heatingthe sample solution to denature (separate)double-stranded DNA.

A cooling cycle then triggers the highlyspecific primers to anneal (bind) to a geneticsequence on the single-stranded DNA.At the same time, a third primer (probe)also anneals to a region of the sequence.Probes contain a fluorescent reporter dye atone end, whose signal is absorbed by thequencher dye at the other end.

As the DNA enzyme extends the primer,it breaks the probe apart. This separatesthe reporter dye from the quencher, whichincreases the reporter signal.

Successive heating and cooling cycles allowthe DNA fragments to replicate (amplify)exponentially. The PCR amplificationprocess completes in about 90 minutes.A separate detection phase is not necessarybecause signal is measured and analyzed atthe end of each cycle during amplification.

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BAX® System Q7 intercalating dye chemistry.

A cooling cycle then triggers the highlyspecific primers to anneal (bind) to agenetic sequence on the single-strandedDNA. As the replicating enzyme begins itscopying process, free-floating intercalatingdye binds to the newly synthesizeddouble-stranded DNA.

Free-floating intercalating dye binds tothis region as the DNA re-forms doublestrands. This chemistry uses a highlyspecific dye that binds to double-strandedDNA as it accumulates during PCR cycles.When exposed to light, the bound dyeemits a measurable fluorescent signal.

Successive heating and cooling cycles allowthe DNA fragments to replicate (amplify)exponentially within a few hours. The PCRamplification process completes in less thanthree hours at the end of a cooling cycle withdouble-stranded DNA. The detection phasebegins when samples are exposed to light.This excites the intercalating dye intoproducing a baseline signal. The temperatureis then slowly raised to denature the DNAand measure the resulting drop in signal,which is analyzed as a melt curve.

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1 PCR reaction tubes contain tablets that arehydrated with prepared test samples.These tablets contain intercalating dye,along with all the reagents, enzymes andprimers needed for the PCR reaction.The primers match a unique genetic regionof the target's DNA. Their selectiondetermines the specificity of the assay.

The PCR process begins with heatingthe sample solution to denature (separate)double-stranded DNA.

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The BAX® System Q7 has the ability to detect up to five different

dyes used for probe-based detection as well as intercalating

dyes, such as SYBR® Green.

The BAX® System process maximizes consistency and helps reduce

operator variability.

Continuous wavelength detection from500-600 μm allows the use of multiple fluorophores

in a single reaction.

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These fully automatedstages produce clearand accurate resultswhile freeing lab staff tocomplete other tasks.

Prepackaged reagents andPCR tablets simplifythe process for exceptionalease of use.

The BAX® System Q7 iscompletely compatible withcurrently available assays.

enrichment

lysis

hydration

DNAamplification

detection

resultsmanagement

Beyond yes-or-no detection, target differentiationand quantitation make the testing process far more

powerful than ever before.

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Sensitivity and specificity for food safety testing.

Testing labs need fast, accurate methods to detect pathogens

in raw ingredients, environmental samples and finished products

to lessen the risks of costly recalls or damaging headlines.

Many labs rely on the genetics-based BAX® System to detect

Salmonella, E. coli O157:H7, Listeria spp., Listeria monocytogenes,

Enterobacter sakazakii and Campylobacter jejuni/coli.

One reason is the exceptional sensitivity of the BAX® System.

This DNA-based technology can detect cell concentrations as low

as 104cfu/ml after enrichment, about one hundred times more

sensitive than most immunoassays.

Another reason is that the BAX® System delivers superior

specificity. Where phenotypic tests can be fooled by bacteria

with similar behavior or appearance, the BAX® System addresses

the unique genetic structure of the target, resulting in fewer

false positive results.

The BAX® System real-time PCR assay not only determines

the presence or absence of the pathogen, it differentiates the

species that are present in each strain and provides a

quantitative count for each in about 90 minutes.

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Flexible, proven food quality testing.

In food quality testing, the emphasis is on spoilage organisms.

Products containing yeast and mold cells do not usually cause

human illness, but high levels of these organisms can cause

products to look, smell, or taste bad. This not only diminishes the

appeal of the product and brand, but can also result in substantial

economic loss to the producer, processor and consumer.

Traditional tests for yeast and mold use culture plates that require

waiting 3-5 days or more for results. The BAX® System PCR Assay

for Yeast and Mold delivers reliable results within 48 hours,

enrichment included. Food labs that accept a relatively high

level of target (>500 cfu/g) can use a direct testing protocol for

same-day results.

The BAX® System can detect yeast and mold before they can impactthe brand by altering the look, smell or taste of a product.

look smell taste

Flexibility is built into the yeast and mold assay.Food companies can select the threshold they desire according

to the concentration level they accept for the food type.Protocols for detection thresholds that range from 10 cfu/g

to more than 500 cfu/g have been established.

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Incredible accuracy by any measure.

The ideal balance of speed and accuracy is maintained,

never sacrificing one for the other.

False positives have been minimized by the BAX® System Q7.

The rate for false negatives is equally impressive.

This accuracy can be measured either in the percentage or

the amount of reduced waste from uncertain testing results.

Or the more efficient use of labor in a testing facility.

Ultimately, the value of accuracy and the benefits of the

BAX® System appear on the bottom line, where they matter most.

The unique genetic signatures of pathogens can be rapidly detectedwith a high level of certainty.

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The amazing speed that the food industry demands.

The BAX® System Q7 does more than speed individual tests.

It has the capability of making your whole operation faster.

The system makes the testing process fast and agile without

sacrificing the industry-leading accuracy that is synonymous

with the BAX® System. This is a PCR testing technology truly

designed for the food industry.

Results on prepared samples can be achieved in 90 minutes or

less, providing the ideal balance between speed and accuracy for

the food industry.

Testing for multiple targets in a single well and having 96 wells

per batch accelerates the entire process. Other improvements

also impact the total time to result, including less hands-on time

preparing samples and faster ramp times and cycling. Even the

smaller 30 μL sample size helps shave valuable minutes from

the process.

Preparation steps use simplified molecular biology techniquesand require no additional specialized skills.

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Pre-measured, pre-packaged tablets in capped PCR tubesallow for multiple target detection in a single sample.

If only everyone were this easy to work with.

The BAX® System Q7 combines laboratory accuracy with real

world practicality.

Safety and quality testing are available in a single platform.

PCR reagents are tableted for unmatched convenience.

Mixing is minimized. Multiple liquid transfers are eliminated.

Hands-on time is significantly reduced.

Potential errors caused by operator technique are minimal.

Accuracy is designed into every step. The pre-measured,

pre-packaged reagent tablets reduce pipetting errors and ensure

consistency. A closed-tube system means you don't have to

open the reaction tubes after processing, virtually eliminating

amplicon contamination in the lab.

Automated processing combines PCR with fluorescent detection

to significantly reduce hands-on time, minimize the potential

for cross-contamination and provide reproducible results based

on computerized algorithms for analysis.

Now that’s a lab partner that everyone can live with.

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Unmistakable results.

Results from prepared samples are clearly displayed as color-coded

wells with “yes-or-no” icons that eliminate the need for expert

interpretation. Electronic files allow you to print, share and store

your results for easy archiving and retrieval.

The entire system is run in a familiar Microsoft® Windows®

environment. Powerful and intuitive software, including online

wizards, makes getting expert results quicker and easier for all

operators, even first-time users.

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Beyond yes-or-no.

Powerful data viewing capabilities supply more detailed

information when needed. Examine a processed view of the

melt curve, raw data and simultaneous analysis of a single well

or up to 96 samples at one time.

Display results in rack view, rack details, well view and

well details.

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Testing applications

ListeriaApplications: A variety of surfaces, including ceramic, plastic,wood, iron, concrete and others.

Certified by AOAC Research Institute as a Performance Testedmethod. Combines a single enrichment step with shorterincubation times—24 hours for swabs and 28 hours for sponges.Performs as well at 24-28 hours as the dual-enrichment USDA-FSISculture method at 48 hours.

SalmonellaApplications: A variety of foods, including meat, poultry,dairy products, fruit and vegetable products, chocolate/bakeryproducts, animal feeds and pasta.

Adopted by the USDA-FSIS and approved by government agenciesand certifying bodies around the world, including AOAC andAFNOR. Performs as well as traditional culture methods fordetecting Salmonella in food, but with quicker time to result.Sensitivity/specificity rates at least 98 percent.

Listeria monocytogenesApplications: A variety of foods, including meat, poultry, fruit andvegetable products, dairy products, fruit juices, egg and eggproducts.

Adopted by the USDA-FSIS and certified by AOAC International asan Official Method for detecting L. monocytogenes.

Camplyobacter jejuni/coliApplications: Poultry carcass rinses.

Validation studies have shown that the BAX® System detects thesestrains of C. jejuni and C. coli in concentrations as low as 10 cellsper 30 ml sample, with next-day results.

E. coli O157:H7 MPApplications: Raw ground beef and beef trim.

Adopted by the USDA-FSIS and certified by AOAC ResearchInstitute as a Performance Tested method. After 8-24 hoursenrichment in proprietary E. coli O157:H7 MP media, performssignificantly better than the USDA-FSIS culture method fordetecting low levels of E. coli O157:H7 in raw ground beef.Uses multiple primers for sensitivity/specificity rates greaterthan 99 percent.

E. coli O157:H7Applications: Raw ground beef, apple cider and orange juice.

With specificity rate of greater than 99 percent, the BAX® Systemfor detecting E. coli O157:H7 has been certified by AOAC ResearchInstitute as a Performance Tested method. For beef samples,enrichment time can be as short as 8 hours. Studies have shownthe BAX® System to be more sensitive than culture for detectinglow-level E. coli O157:H7 contamination.

Enterobacter sakazakiiApplications: Selected foods including powdered infant formula,dry dairy and soy ingredients and food production environmentalsamples.

The BAX® System has demonstrated 98 percentsensitivity/specificity rates and performs as well as traditionalculture methods with next-day results.

Yeast and MoldApplications: Prepared food including shredded cheese andflour products.

Thresholds can be customized for different food products.Validation studies show that the BAX® System reliably reportspositive results for samples with yeast and mold at or above thecut-off threshold.

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Leadership is in the genes.

From the beginning, the advanced, genetic-based DuPont Qualicon

technology has had a tremendous impact on the food industry.

For over 200 years, DuPont has been first to develop technological

solutions with powerful business value. DuPont Qualicon is part

of that strong tradition and has grown to become a global leader

in DNA-based diagnostic solutions.

DuPont Qualicon has set new standards for accuracy, the value

of which can be measured in the percentage or the amount of

reduced waste from uncertain testing results. Or the more efficient

use of labor in a testing facility. Ultimately, the value of accuracy

and the benefits of DuPont Qualicon technology appear on the

bottom line, where they matter most.

Many of the leading food companies around the world trust

Qualicon to safeguard their brands and their customers.

Government testing agencies in the United States, Canada, Brazil,

Japan and other parts of the world have adopted or certified

the BAX® System as an approved testing method to help protect

their food supply and their citizens.

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Also delivered with the system:Limited license to perform PCRHeating block assembliesCooling block assembliesCapping/decapping toolsPipettesStart-up suppliesUser documentation

USDA-FSIS

AOAC

AFNOR

Brazilian Ministryof Agriculture

Health Canada

Japanese Ministryof Health

Swedish NationalFood Association

System components:BAX® System Q7 cycler/detectorComputer workstation and printerBAX® System application and Microsoft® Windows® OSInstallation and training

Everything you need in one package.

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You have heard of industry-altering technology

that was always on the horizon.

With the arrival of BAX® System Q7—

the technology is now here for you to utilize.

The food industry can use this precision, flexibility

and control to harness what it needs most.

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The power to do more.™

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Qualicon.com

DuPont QualiconESL Building 400P.O. Box 80400Route 141 and Henry Clay RoadWilmington, DE 19880-0400 USA

1.800.863.6842 phone302.695.5300 phone outside US302.695.5301 fax

DuPont (UK) LimitedWedgwood Way, StevenageHerts SGI 4QN, UK

+44(0)1438 734500 phone+44(0)1438 734974 fax

DuPont Company (Singapore) Pte, Ltd.1 Harbour Front Place #11-01Harbour Front Tower One,Singapore 098633

+65 6586 3635 phone+65 6586 3494 fax

Use as directed in the BAX® System User Guide for research and development, quality assuranceand quality control under supervision of technically qualified persons. Not approved for clinical diagnosis.Please read the limitation of warranty and liability before use.

Copyright © 2006 E.I. DuPont de Nemours and Company. All rights reserved. The DuPont Oval Logo, DuPont™, The miracles of science™

and BAX® are registered trademarks or trademarks of E.I. DuPont de Nemours and Company or its affiliates. BAX® Systems are sold underlicensing arrangement with F. Hoffman-La Roche, Roche Molecular Systems, Inc. and Applied Biosystems. SYBR® is a registered trademarkof Molecular Probes, Inc. Microsoft® and Windows® are registered trademarks of Microsoft Corporation. 2AQ-015-0406