Visibly Simple Food Pathogen Testing - Thermo Fisher Scientific PDF

Food Testing Visibly simple food pathogen testing. Thermo Scientific™ SureTect™ PCR System– simple, rapid workflows designed to get results  Innovating your Pathogen Detection System In your pursuit of food safety, every test matters. There’s no time to start again or wonder if the...

Food Testing Visibly simple food pathogen testing. Thermo Scientific™ SureTect™ PCR System– simple, rapid workflows designed to get results  Innovating your Pathogen Detection System In your pursuit of food safety, every test matters. There’s no time to start again or wonder if the products you use will set you back or propel you forward. With our comprehensive portfolio of assays combined with world-class instrumentation, you can perform food safety tests confidently knowing exactly what you are getting– quality combined with simplicity. We are committed to enabling you to experience true confidence in your results. The innovative Thermo Scientific™ SureTect™ Food Pathogen Detection PCR System has evolved to even better support your laboratory and your testing needs. Take advantage of simple, streamlined, automatable workflows that utilize a single same-day or overnight enrichment step, common direct lysis protocol for DNA release, and universal cycling parameters. Learn more at thermofisher.com/suretect 2  Contents Introduction 2 Thermo Scientific SureTect PCR System 4 Thermo Scientific SureTect PCR Assays 6 Thermo Scientific SureTect PCR Assays – Order information 9 Easy-to-use tools to simplify your workflow handling 11 SureTect Automation Workflow 13 Applied Biosystems SimpliAmp Thermal Cycler 15 Applied Biosystems QuantStudio 5 Food Safety PCR System 17 Thermo Scientific RapidFinder Analysis Software 20 3  Thermo Scientific SureTect PCR System It’s better to be sure Experience complete confidence, with the tools to help you attain food pathogen detection results that are right first-time, every time. Transform your complete food safety testing workflow with the SureTect PCR System, enabling you to work efficiently and release products quickly with a simple, rapid pathogen detection system validated for a broad range of matrices. With the SureTect PCR System, you will move forward confidently knowing you are helping protect consumers, your brand, and your bottom-line with a food pathogen testing system that delivers speed, accuracy, and reliability of results. Streamlined, automatable and rapid workflows The simplicity of the SureTect PCR System sample preparation has now been enhanced so that up to 96-well runs can be prepared with just a few simple steps, enabling time savings compared to other manual and automated sample preparation systems. Single, versus dual enrichment protocols for faster time-to-result and streamlined workflow Test for multiple targets from a single enrichment for maximum productivity Universal PCR conditions for detecting multiple targets in the same run ‘Plug and play’ ready-to-use instruments out of the box Fully automated amplification, detection, data collection and data analysis using Thermo Scientific™ RapidFinder™ Analysis Software v3.0 or later 4 thermofisher.com/suretect  SureTect PCR Workflow 8-24 hours Enrichment Single enrichment step of 8-24 hours (depending on target and matrix). 20-40 minutes Sample preparation and lysis Manual preparation with direct lysis in the Applied Biosystems™ SimpliAmp™ Thermal Cycler, or fully automated lysis and PCR preparation using the CyBio™ FeliX instrument as part of the SureTect Automation Workflow. ~80 minutes Run & read Perform PCR with the Applied Biosystems™ QuantStudio™ 5 Instrument using the RapidFinder Analysis Software. Results are automatically interpreted. Report/confirm Report PCR-negative results immediately and confirm PCR-positive results after overnight incubation. 5  Thermo Scientific SureTect PCR Assays Validated for a broad range of targets and matrices according to the certification requirements of AOAC and ISO 16140-2:2016 (by AFNOR or MicroVal). The SureTect PCR Assays provide the ultimate solution for all your pathogen detection requirements. Pre-dispensed lysis and PCR reagents, reducing handling steps and risk of operational error Clearly oriented lysis and assay plates reducing human error Color indicator in Proteinase K Reagent enabling tracking of pipetted wells Pierceable Seals for Lysis Tubes to reduce handling steps and cross-contamination Assay Strip Plates color-coded to target pathogens Thin-walled polypropylene wells ensure superior thermal cycling performance for consistent results run after run Internal positive control (IPC) in every well providing confidence in each and every result All assays compatible with manual and automated sample preparation workflows 6 thermofisher.com/suretect  Everything needed to simplify your workflow and help you achieve reliable pathogen test results 7  Flexibility for efficient laboratory working Universal PCR conditions enable multiple target detection in the same run Easily and safely broken into 8-tube strips by hand and easy splitting of strips with the Thermo Scientific™ PCR Strip Cutting Tool for maximum flexibility and convenience Easily and safely divided into 8-tube strips Use only the number of Assay Tubes needed for each PCR run Easy visual organization Target-specific colored Assay Plates and orientation markings No warping, even after thermal cycling Hard shell for mechanical stability and flatness Snug fit to thermal blocks Thin-wall polypropylene for excellent mechanical fit and heat transfer Did you know? Proper plate sealing helps reduce evaporation and well-to-well contamination. 1. Remove the backing of the Thermo Scientific™ 96-well Pierceable Seal 2. Align the adhesive Pierceable Seal film to cover all wells 3. Rub the flat edge of the Thermo Scientific™ MicroAmp™ Adhesive Film Applicator along the long edge (length) of the plate, then along the short edge (width) 8 thermofisher.com/suretect  SureTect PCR Assays Each SureTect PCR Assay contains all of the ready-to-use reagents and consumables for your food SureTect PCR Assay workflows: 96-well Lysis Tube Strip Plate pre-filled with Lysis Reagent 1, Blue-tinted Proteinase K Reagent, Pierceable Lysis Tube plate sealing films, 96-well PCR Tube Strip Plate pre-filled with Lyophilized PCR components and optical PCR cap strips. Ordering information Product Description Cat. No Thermo Scientific™ SureTect™ Rapidly detect Campylobacter jejuni, C. coli and A56835 Campylobacter jejuni, C. coli and C. lari in food and environmental samples with the C. lari PCR Assay SureTect Campylobacter PCR Assay. Reliably detect and differentiate Campylobacter from poultry samples, without using gas jars, within 24 hours. AOAC-RI validated on poultry products, with a range of test portion sizes. Thermo Scientific™ SureTect™ Simply and accurately detect Cronobacter species in low A56845 Cronobacter species PCR assay and high sample sizes of powdered infant formula, with and without probiotics, and ingredients in less than 20 hours. ISO 16140-2:2016 validated on infant formula and cereals with and without probiotics, related ingredients and production environment samples. Thermo Scientific™ SureTect™ Detect E. coli O157:H7 rapidly with the highly-specific, A56844 Escherichia coli O157:H7 PCR real-time SureTect E. coli O157:H7 PCR Assay. Validated Assay on beef meats, fruits and vegetables including large test portion sizes following the AOAC-RI and the ISO 16140- 2:2016* technical rules. Thermo Scientific™ SureTect™ Rapidly detect multiple genetic targets for Shiga-toxin A56838 Escherichia coli O157:H7 and producing Escherichia coli O157:H7 and other STEC in STEC Screening PCR Assay food and environmental samples. Part of a complete workflow for the rapid detection of Escherichia coli O157:H7, stx, eae, and the Escherichia coli STEC serotypes (O26, O45, O103, O111, O121, O145) from Thermo Scientific™ SureTect™ food samples within as little as 10 hours. Samples A56840 Escherichia coli STEC assessed as positive using the SureTect E. coli O157:H7 Identification PCR Assay and STEC Screening PCR Assay are further tested using the SureTect E. coli Identification PCR Assay. AOAC-RI and ISO 16140-2:2016 validated on a range of food matrices including raw meat (excluding poultry), vegetables, fruits, juices, and dairy samples. Thermo Scientific™ SureTect™ Detect Listeria monocytogenes or all Listeria species in A56843 Listeria monocytogenes PCR even the most challenging food types with the SureTect Assay L. mono or SureTect Listeria species PCR Assays which incorporates optimized primer and probe components for highly-specific detection of L. monocytogenes. The Assays are AOAC RI, AOAC-OMA and ISO 16140- Thermo Scientific™ SureTect™ 2:2016* validated for a broad range of foods and A56842 Listeria species PCR Assay environmental samples for additional confidence in your results. *validation according to the ISO 16140-2:2016 standard by AFNOR Certification or MicroVal 9  SureTect PCR Assays Ordering information Product Description Cat. No Thermo Scientific™ SureTect™ Detect Salmonella species in food and environmental A56841 Salmonella species PCR Assay samples with the SureTect Salmonella species PCR Assay which incorporates optimized primer and probe components for highly-specific detection of Salmonella species. The assay has been AOAC-RI, AOAC-OMA and ISO 16140-2:2016* validated for a broad range of foods and petfood including large test portions. Thermo Scientific™ SureTect™ Rapidly detect Staphylococcus aureus in food and A56839 Staphylococcus aureus PCR environmental samples, including infant formula, in Assay less than 24 hours. AOAC-RI validated covering dairy products including infant formula together with other low moisture products and cheeses. Thermo Scientific™ Rapidly detect Vibrio cholerae, V. parahaemolyticus A56837 SureTect™ Vibrio cholera, and V. vulnificus in food samples in as little as 10 V. parahaemolyticus and V. hours. AOAC-RI validated on fish and seafood vulnificus PCR Assay products, with a range of test portion sizes. Thermo Scientific™ RapidFinder™ A56846 Salmonella species, Typhimurium Simultaneously detect and type Salmonella species, and Enteritidis Multiplex Kit S. Enteritidis and S. Typhimurium with the RapidFinder Salmonella multiplex PCR Kits. AOAC-RI and ISO 16140-2:2016* validated in raw and processed meats, Thermo Scientific™ RapidFinder™ pork and poultry meats, egg products, production A56847 Salmonella species, Typhimurium environmental samples and primary production. and Enteritidis Flex Multiplex Kit Thermo Scientific™ SureTect™ Rapidly confirm Salmonella Infantis in poultry. A56450 Salmonella Infantis PCR Assay Complimentary to the RapidFinder Salmonella Multiplex Kit and designed to run simultaneously, the SureTect Salmonella Infantis Assay requires no additional time or data interpretation steps. Thermo Scientific™ SureCount™ Simultaneously quantify and type Salmonella species A56848 Salmonella species, Typhimurium and serotypes Typhimurium and Enteritidis in around and Enteritidis PCR Kit 8 hours. Currently undergoing AOAC Performance Tested Methods (PTM) validation for poultry, beef, and pork matrices. SureTect™ Brettanomyces spp. Designed for control programs in beverage production, A59289 and Saccharomyces cerevisiae the Thermo Scientific™ SureTect™ Brettanomyces spp. Multiplex PCR Assay and S. cerevisiae Multiplex PCR Assay rapidly detects and differentiates both Brettanomyces and S.cerevisiae in product and environmental samples. Highly specific, the assay covers the 3 main species of Brettanomyces: B. naardenensis, B. anomalus and B. bruxellensis, enabling robust, rapid response to contamination and faster product release. *validation according to the ISO 16140-2:2016 standard by AFNOR Certification or MicroVal 10 thermofisher.com/suretect  Easy-to-use tools to simplify your workflow handling Designed specifically to enhance each step of the SureTect PCR Assay Workflow, the new SureTect PCR Workflow tools enable ease- of-handling, reduced hands-on time and operator error providing a superior user handling experience. Ordering information Product Description Cat. No Thermo Scientific™ PCR Strip Cutting tool for Strip Plates–used to cut both lysis tube A55329 Cutting Tool strips and PCR change to PCR Assay Tube strips tube strips, if fewer than 8 tubes are required for the analysis Thermo Scientific™ Lysis Tube Opening tool for Strip Plates–used to remove the domed A55328 Uncapping Tool lysis caps from the lysis tubes Thermo Scientific™ PCR Capping Capping tool for SureTect Lysis and PCR Assay Strip A55327 Tool Plates Thermo Scientific™ 96-well PCR 96-well base for Strip Plates–hold and stabilize both the A55330 Base Lysis Tubes and Assay Plate Thermo Scientific™ MicroAmp™ Pack of 5 4333183 adhesive film applicator For easy, consistent application of Pierceable Seals 11  Accessories Each SureTect PCR Assay comes with all the reagents and PCR accessories needed to set up your SureTect PCR Assay tests to run on the Applied Biosystems™ QuantStudio™ 5 Food Safety PCR System. Additional SureTect Accessories are available to order separately, including, low-profile PCR Strip Plates for balancing when using the Applied Biosystems™ 7500 Fast Food Safety PCR System and Domed Lysis Tube Caps for use if preferred in place of the Pierceable Lysis Seals. Ordering information Product Description Cat. No Thermo Scientific™ 96-well Pack of 100 seals A55331 Pierceable Seal 2 included with each kit Alternative option to lysis caps Print around each well for positioning and orientation Strip perforations Thermo Scientific™ Lysis Tube Pack of 120 strips A56895 Caps, domed Provide the option for caps in addition to pierceable seals for lysis Thermo Scientific™ Low-Profile For balancing of Applied BioSystems™ 7500 fast plates AB2696SMP PCR Strip Plate, 96 well, clear Thermo Scientific™ Ultra clear Strips of 8, 120 caps PT0615 qPCR caps Additional PCR caps if required 12 thermofisher.com/suretect  SureTect Automation Workflow With the Thermo Scientific SureTect Automation Time Saving Workflow, you can take your food safety testing Fully automated lysis & PCR setup to the next level with automated lysis and PCR Rapid 5-minute setup time for loading preparation. reagents Utilising the CyBio™ FeliX Instrument, the automated workflow and rapid setup allows Accurate & Traceable you to reduce hands-on time whilst increasing Enhanced pipetting accuracy, minimizing risk of human error the accuracy of your testing, enabling your technicians to focus on other tasks. Barcoded sample entry for full traceability With a user-friendly interface and innovative Flexible yet compact dual deck design, the CyBio FeliX Up to 6 different assays/96 samples on instrument enables efficient, accurate lysis and the same run PCR preparation whilst saving valuable bench Choose from full or partial plate processing space. Automate lysis, PCR setup or the Fully validated by AFNOR and AOAC for use with complete workflow all SureTect Assays, the instrument’s flexible programs and precise pipetting accuracy ensure Intuitive Software maximum efficiency and reproducibility. User-friendly interface Pre-programmed runs for quick setup Key benefits of the CyBio™ FeliX Instrument Ready-to-use, specific SureTect protocols Integrated heating and cooling block Choose between the CHOICE head for simultaneous 8-sample pipetting or the Head R 96 for 96-sample pipetting Unique 2-level deck Comprehensive service packages Fully validated system - AFNOR and AOAC Compact design: - Dimensions: 650 x 450 x 700 mm - Weight: 58 kg 13  SureTect Automation Workflow CyBio Felix Instrument Specifications Compatible with all SureTect Assays Open platform capabilities Features Integrated heating and cooling block Up to 96 samples/6 assays per run Model number 30-5015-100-24/0L5015-100-24 1-384 channels (depending on version and pipetting head) Pipetting channels The 384 channel is not available through Thermo Fisher Scientific Dimensions 650 x 450 x 700 mm Weight Approx. 58 kg (Device ready for operation) Microplate specifications 96-, 384- shallow well MP (Formats -SBS Standard) 96-, 384- deep well MP Deck positions Name/number: 1-12 positions Lower level - max. height (accessory) 110 mm Upper level - max. height (labware) 65 mm Tubes 0.2-2 mL Technical and Operating Data Application class Bench-top device, closed room facilities in clean condition Protection class I Mains voltage and frequency 100 – 240 V AC ±10%, 50/60 Hz Degree of contamination 2 Permissible ambient temperature +15 °C to +35 °C Permissible relative humidity ≤ 75 % at +35 °C non-condensing Ordering Information Item Description Order code Automation Platform CHOICE Head A59017 Automation Platform, one of Automation Platform Head R 96 A66295 the following: Automation CHOICE Head package A66296 Automation Head R 96 package A66297 SureTect Automation ™ Downloadable at thermofisher.com/molecular-microbiology-software A66373 Software Laptop 3551 W10IOT19 RC Or equivalent performing A49006 SureTect™ Automation Starter Pack: A59905 Automation Lysis Tray A59019 Automation PCR Adapter A59018 SureTect™ Automation Starter Pack Thermo Scientific 96-Well PCR Base A55330 QuantStudio 5 Strip Plate Tray ™ A55332 Thermo Scientific™ PCR Strip Cutting Tool A55329 Thermo Scientific PCR Capping Tool ™ A55327 Filter Tips for SureTect Automation 96 (12 boxes) A66298 Filter Tips Filter Tips for SureTect Automation 8/96 (10 boxes) A59033 Sample Enrichment Tubes A59902 Enrichment Tubes Caps A59903 Waste Bags​ Waste bags for SureTect Automation A59034​ Protective Plate Protective Plate for SureTect Automation A66299 14 thermofisher.com/suretect  SimpliAmp Thermal Cycler Utilize the Applied Biosystem™ SimpliAmp™ Key benefits Thermal Cycler in the SureTect PCR Assay workflow to prepare lysates from enriched Intuitive interface samples ready for PCR. Large, easy-to-use color touchscreen for By automating the incubation steps for cell easy programming and quick status checks lysis, samples are ready for PCR in around 20 minutes with minimal hands-on steps required. VeriFlex Block The SimpliAmp Thermal Cycler will hold samples Three independent temperature zones for ready for use at 4°C once the lysis steps are PCR optimization completed. With a responsive color touchscreen and Applied Cloud-enabled Biosystems™ VeriFlex™ temperature control Conveniently access your instrument anytime, technology, the SimpliAmp Thermal Cycler anywhere with the Connect Platform enables simple, accurate optimization in addition to cloud enablement, giving you the freedom Compact design to design and securely upload your methods, Helps save valuable bench space monitor runs, and check instrument availability from any mobile device or desktop computer with the Connect Platform. Key benefits Elegantly simple and precise SimpliAmp Thermal Cycler 96 reactions 4.0°C/sec 96-well, 0.2 mL (3–zone Veriflex Block) Select your saved SureTect Sample Preparation program The status dial displays the current block temperature and elapsed run time Create a new run method using default templates or existing methods Use the instrument as a precise incubator for non-PCR workflows 15  SimpliAmp Thermal Cycler Specifications Block format 96-well, 0.2 mL, 3-zone VeriFlex Block Features Enabled to run Fast chemistry Auto restart (after power outages Controllable ramp rate Edit program during experiment Program overwrite protection One-touch incubation Max. block ramp rate* 4°C/sec Max. sample ramp rate* 3°C/sec Temperature accuracy ±0.25°C (35–99.9°C) Temperature uniformity 1,000 protocols); USB port for additional external storage Display interface 8 inch color TFT LCD Power 100–240 V, 50–60 Hz, max. 600 W VeriFlex Block 3 temperature zones, 20°C range (10°C zone-to-zone) Data connectivity** Cloud or mobile via Ethernet or Wi-Fi * At reaction volume of 1 μL. ** The Instrument Connect app, available at Apple and Google app stores, can be used to monitor your instrument. The Connect Platform can be used to create and share protocols, schedule an instrument, and start and monitor runs remotely Ordering information Product Cat. No SimpliAmp Thermal Cycler A24811 Recommended Accessories SimpliAmp Strip Plate Tray A55333 SimpliAmp Strip Plate Tray cover A55971 Did you know? SimpliAmp Thermal Cyclers have thermal simulation modes that make the transition from other thermal cyclers simple, accurate, and efficient. A library of modes that mimic the ramp rates of other instruments is available on each instrument. 16 thermofisher.com/suretect  QuantStudio 5 PCR System The SureTect PCR Assays are validated to run on the Applied Biosystems™ QuantStudio™ 5 Food Safety Real-Time PCR System. The QuantStudio 5 Food Safety PCR System is a high-performance benchtop platform, combining ease-of-use and system connectivity with powerful options that enable maximum data utility and control. Benefit from the flexibility of a 6-channel, 96-well, cloud-enabled open platform suitable for running our full range of PCR solutions for food safety, authenticity, and quality testing. Intuitive and simple Easy to use for all levels of experience. Touchscreen usability, allowing you to stay connected to your data easily Multiplex with ease Up to six excitation and six emission filters offer 21 different color combinations, allowing a broad range of detection chemistries and maximum multiplexing Get up and running quickly Factory-calibrated for accuracy, quick installation, and immediate use; preoptimized protocol templates help minimize training for new users Maximize benchtop space Compact instrument can be configured as a stand-alone or with a computer Open instrument Suitable for all our food safety, authenticity, and quality PCR tests. Intuitive, user-friendly software, avoiding subjective interpretation. Cloud-enabled, offering the potential for data sharing, analysis and trending. Capacity for processing several hundred samples a day 17  QuantStudio 5 Food Safety PCR System Specifications For when you need: Total control QuantStudio 5 Food Safety PCR System Colors 5 or 6 colors (21 filter combinations) Available formats 96-well (0.1 mL block) Dimensions (H x W x D) 40 x 27 x 50 cm Block change Fixed VeriFlex temperature control Yes, 6 zones (96-well blocks only) Throughput Medium –High 21 CFR Part 11–enabled Security, auditing, e-signature package Touchscreen Yes, interactive Cloud-enabled Yes Automation compatible Yes Key Food Applications Food pathogen detection GMO testing Meat and Fish species Identification Legionella detection and quantification 18 thermofisher.com/suretect  QuantStudio 5 Food Safety PCR System Specifications continued QuantStudio 5 Food Safety PCR System Sample capacity (wells) 96 Reaction volume 96-well, 0.1 mL block: 10–30 μL Footprint (H x W x D) 40 x 27 x 50 cm Excitation source Bright white LED Optical detection 96-well: 6 decoupled filters Excitation/detection range 96-well: 450–680 nm/500–730 nm Multiplexing 96-well: up to 6 targets 2D barcode reading Optional Heating/cooling method Peltier Temperature zone function 96-well: 6 VeriFlex zones Max. block ramp rate 0.1 mL block: 9.0°C/sec Average sample ramp rate 3.66°C/sec Temperature uniformity 0.4°C Temperature accuracy 0.25°C Run time 96-well block: