MagNA Pure 96 System. Nucleic Acid Purification with Real High Throughput

MagNA Pure 96 System Nucleic Acid Purification with Real High Throughput

The MagNA Pure 96 System purifies DNA, RNA, and viral nucleic acids from a wide range of starting materials using magnetic glass particle technology. Preprogrammed software protocols are tailored to a diversity of sample requirements. Resulting nucleic acids are suitable for a broad range of downstream applications. The MagNA Pure 96 System effortlessly processes up to 96 samples in less than one hour using barcoded, prefilled trays with ready-to-use reagents. Experience seamless data management using intuitive features, such as the link to a laboratory information management system (LIMS). System Features 3 System Features System Benefits 4 System Benefits Reagents and Disposables 6 Reagents and Disposables MagNA Pure 96 Software 7 MagNA Pure 96 Software Specifications 8 Specifications Kits and Protocols 9 Kits and Protocols Performance Data 10/13 Performance Data Ordering Information 11 Ordering Information 2

MagNA Pure 96 System Discover effortless nucleic acid isolation Magnetism is used for automated nucleic acid isolation performed by the MagNA Pure 96 System from Roche Applied Science. The high throughput MagNA Pure 96 Instrument performs automated nucleic acid purification from samples up to 1000 µl, pipetted into a 96-well processing cartridge. Magnetic glass particles (MGPs) are used to isolate RNA, DNA and total nucleic acids (tna) from a variety of different sample materials. The MagNA Pure 96 System permits automated nucleic acid purification that matches the high speed, accuracy, and reliability of LightCycler Real-Time PCR Systems. System Features Key features of the MagNA Pure 96 System are: Sample number Sample volumes Max. number of sample types within one run Run time for 96 reactions Reagent type LIMS connectivity 21CFR part 11 (subsection B) compatibility IVD compliance 1 to 96 reactions per run 50 to 500 µl with 96 reactions per run 1000 µl with 48 reactions per run 10 (whole blood, plasma, serum, urine, swabs, stool, sputum, BAL, CSF, bacterial cultures) Approx. 50 60 minutes for 200 µl sample volumes Approx. 80 90 minutes for 500 µl sample volumes Prefilled, ready-to-use Instrument complies with the requirements of IVD directive 98/79/EC 3

MagNA Pure 96 System Discover real high throughput The MagNA Pure 96 System performs fast high throughput processing of a multitude of sample materials. Robust engineering produces consistent results, minimizing maintenance and downtime. System Benefits Feature Speed and throughput Approx. 1 hour for processing a 96 sample run Multiple sample types can be processed in one run Benefit Quick time-to-result for clinicians and patients Convenience Only two kits needed to cover various diagnostic applications Few reagents and consumables needed Connectivity (LIMS and bidirectional file sharing) Robustness Insusceptible against tested substance interferences Very stable against cross contamination Performance Broad range of sample materials Excellent precision, purification efficiency and linear range Minimal lot-to-lot variation Minimized error risk Low training effort & hands-on time Confidence & trust in your results One solution for various needs Service and support Globally, approx. 3500 employees at Roche Diagnostics are dedicated to service and support Roche is a leading supplier of IVD products. No other company has more experience in molecular diagnostics Minimum downtime Cost effectiveness 4

MagNA Pure 96 System All samples are urgent samples Process 1 to 96 standard-volume samples in less than one hour, including the handling time that is needed for the setup of a run. Larger volumes typically require 80 to 90 minutes for a run. Two robotic pipetting arms are used to process the up to 96 samples absolutely standardized at the same time. The reagent head pipetting arm uses four individually controlled fluid channels to transfer reagents during purification. The 96-nozzle process head pipetting arm uses CO-RE tip technology to purify nucleic acids in processing cartridges. System Benefits G Figure 1: Process head G Figure 2: Reagent head Using two robotic heads ensures high level process parallelization for high speed nucleic acid isolation. 5

MagNA Pure 96 System Convenient setup with reliable reagent and consumables verification The few consumables used are barcoded. Prefilled ready-to-use reagent trays and consumables are easily loaded into racks, ensuring user safety. The second set of racks permits straightforward reagent tray exchange, when, for example, purifying cellular RNA from samples, after isolating DNA from a previous batch. In addition, the onboard magnetic glass particle shaker eliminates the need to manually vortex MGPs before loading them into the instrument. Barcode reading is integrated throughout the purification procedure. This feature minimizes the risk of user errors during loading and enables full process documentation. Reagents and Disposables G Figure 3: A reagent rack in the process of being loaded with reagent trays G Figure 4: Example of a reagent tray containing a unique barcode identifier 6

MagNA Pure 96 Software Easy to learn, easy to use Users find it easy to learn the MagNA Pure 96 System. The intuitive graphical user interface provides all instructions to operate the system. The system guides the user from sample loading to starting the run. This advanced software has been designed to detect loading errors and guide the user to the appropriate corrective action. For example, when a reagent is loaded in the wrong position, the system prevents a run from being started until the reagent is repositioned correctly. MagNA Pure 96 Software G Figure 5: Overview screen of the MagNA Pure 96 Software Sample information can be imported into the MagNA Pure 96 Software via internal or external barcode scanner, LIMS, or entered manually. Data can be exported in several formats, such as *.xml. Perform bidirectional file sharing and LIMS connectivity. Software-based audit trail, user management, and process monitoring functionalities are 21CFR part 11 (subsection B) compatible. 7

MagNA Pure 96 System Specifications General Type Sample number Benchtop standalone instrument with separate control unit 1 to 96 reactions per run Sample volume 50 to 500 μl with 96 reactions per run 1000 μl with 48 reactions per run Elution volume 50 to 200 µl Run time Approx. 50 to 60 minutes for 200 μl sample volumes Approx. 80 to 90 minutes for 500 μl sample volumes Setup time: Approx. 5 minutes (Instrument loading, entering run & sample information into software) Preventive maintenance Annually or after 1000 runs IVD compliance In compliance with requirements of the IVD directive 98/79/EC Hardware Specifications Hardware footprint, dimensions Weight Liquid handling Power supply Power consumption Electrical approvals Emission UV lamp Drop catcher W x D x H: 136 x 81.5 x 100 cm (53.9 x 31.5 x 39.4 in) Approx. 235 kg/518 lbs (instrument) Two robotic arms: 1. Reagent head with four individually controlled fluid channels 2. Process head with a 96-nozzle pipette head (CO-RE tip technology) 100 to 125 V ( 15%, +10%) 200 to 240 V (-15%, +10%) ~450 VA max CE, UL 254 nm Software, Interfaces & Connectivity 21CFR part 11 (subsection B) Compatibility Data storage Data export Audit trail User management LIMS connectivity Bidirectional file sharing In database format *.xml, LightCycler sample input file in csv format (*.txt) (e.g., via HL7 transfer protocol) 8

MagNA Pure 96 Reagent Kits Just the number of reagents and consumables you need The precisely engineered kits are designed profiting from our more than ten year expertise in magnetic glass particle technology. We have streamlined the purification process to a very small number of reagents, consumables and steps. Optimized preprogrammed purification protocols ensure routine sample handling and high quality, reproducible nucleic acid yields. Reagents & Disposables MagNA Pure 96 DNA and Viral NA Small Volume Kit Cat. No. 06 543 588 001 MagNA Pure 96 DNA and Viral NA Large Volume Kit Cat. No. 06 374 891 001 MagNA Pure 96 Cellular RNA Large Volume Kit Cat. No. 05 467 535 001 Reagent type Prefilled, ready-to-use Automated shaking of magnetic glass particles (MGP) Internal control option Instrument monitoring of expiry dates Unopened kit storage temperature +15 to +25 C Dedicated external lysis buffers available Kit Name DNA and Viral NA Small Volume Kit (Catalog No. 06 543 588 001) DNA and Viral NA Large Volume Kit (Catalog No. 06 374 891 001) Cellular RNA Large Volume Kit (Catalog No. 05 467 535 001) Pack Size 3x192 3x96 Target NA Sample Material/Volume Elution Volume Up to 5x10 5 culture cells Genomic DNA Viral DNA and RNA Viral DNA and RNA, bacterial and fungal DNA Viral DNA and RNA 50 or 100 Protocol Name DNA Cells SV 55 100 or 200 µl whole blood 50 or 100 DNA Blood SV 53 Lysed sample from 100 or 200 µl whole blood DNA Blood ext lys SV 49 Up to 5 mg fresh tissue or up to 5 FFPE tissue sections 100 or 200 DNA Tissue SV 60 1 FFPE tissue section (5 20 µm thickness) 50 or 100 DNA Tissue FFPE SV 60 100 or 200 µl plasma, serum or whole blood Viral NA Universal SV OR 55 Viral NA Plasma SV Lysed sample from 100 or 200 µl plasma, serum or whole blood Plasma, serum, whole blood, urine, bronchoalveolar lavage (BAL), sputum, cerebrospinal fluid (CSF), swabs, stool and bacterial cultures. Sample Volume 200 µl 50 or 100 Min. Viral NA Universal ext lys SV 47 OR Viral NA Plasma ext lys SV Pathogen Universal 200 58 Up to 1x10 6 culture cells DNA Cells LV 80 3x96 Genomic 500 µl whole blood DNA Blood LV 500 72 DNA Lysed sample from 500 µl whole blood 100 or 200 DNA Blood ext lys LV 500 75 Up to 25 mg fresh tissue DNA Tissue LV 80 3x48 1000 µl whole blood (containing up to 1x10 7 blood cells) DNA Blood LV 1000 75 500 µl plasma or serum Viral NA Universal LV 500 OR 77 Viral NA Plasma LV 500 3x48 3x96 3x48 3x96 3x48 3x96 Viral DNA and RNA, bacterial and fungal DNA Total RNA Lysed sample from 500 µl plasma or serum Plasma, serum, whole blood, urine, bronchoalveolar lavage (BAL), sputum, cerebrospinal fluid (CSF), swabs, stool and bacterial cultures. Sample Volume 500 µl Plasma, serum, whole blood, urine, bronchoalveolar lavage (BAL), cerebrospinal fluid (CSF), swabs, and bacterial cultures. Sample Volume 1000 µl Viral NA Universal ext lys LV 69 500 OR Viral NA Plasma ext lys LV 500 Pathogen Universal 500 90 Pathogen Universal 1000 96 Up to 1x10 6 culture cells 50, 100, 200 RNA Cells 80 The complete WBC sediment of one Paxgene tube 100 or 200 RNA PaxGene LV 86 (2,5 ml Whole Blood) Half the WBC sediment of one Paxgene tube (2,5 ml Whole Blood) RNA PaxGene Half Tube LV 86 Lysed sample from 400 µl whole blood 50 or 100 RNA Blood 400 90 Lysed sample from 800 µl whole blood RNA Blood 800 92 Up to 25 mg fresh frozen tissue or RNAlater stabilized tissue 50, 100, 200 RNA Tissue FF High LV 91 Up to 20 mg fresh frozen tissue or RNAlater stabilized tissue 50, 100, 200 RNA Tissue FF Standard LV 93 1 FFPE tissue section (5 20 µm thickness) 50 or 100 RNA Tissue FFPE LV 87 Kits and Protocols G Table 1: Applications for the MagNA Pure 96 System. 9

MagNA Pure 96 System Performance data Representative performance data are shown below. The data show exemplarily the performance of the most common sample materials in order to demonstrate the state of the art performance of the system. As results obtained may differ depending on sample and parameter, appropriate performance characteristics have to be established by the user. For diagnostic purposes the results shall always be assessed in conjunction with the relevant application and other findings. Precision of purification efficiency To determine the precision of the purification efficiency, genomic DNA was purified from whole blood. Yield and purity of the isolated nucleic acids were determined by OD measurement. Experimental setup and the results are described below: Linear range and limit of detection (LoD) The linear range and the limit of detection (LoD), that can be achieved using the MagNA Pure 96 DNA and Viral Nucleic Acid Kits for automated nucleic acid purification in combination with the MagNA Pure 96 Instrument was evaluated, using virus stock material from Parvo B19 virus and from Hepatitis A virus (both available in-house only). Performance Data Experimental setup to perform analysis of yield and purity: Kit type Purification protocol Sample type Sample input volume 200 µl Elution volume 100 µl Replicates per run 24 MagNA Pure 96 DNA and Viral NA SV Kit DNA Blood SV Whole blood (7.6 x 10 6 white blood cells/ml) Results (mean values) for DNA yield and purity of genomic DNA purified from whole blood: Run 1 Run 2 Run 3 Yield (µg) 5.6 5.6 5.5 CV (%) 3.9 5.5 6.5 OD 260/280 1.9 1.9 1.9 CV (%) 2.5 4.4 1.8 Experimental setup to determine the linear range and the limit of detection: Kit type MagNA Pure 96 DNA and Viral NA LV Kit Purification protocol Viral NA Universal LV Sample type EDTA plasma Sample input volume 500 µl Elution volume 50 µl 8 different virus titers: Dilution series 2 x 10 1 to 5 x 10 7 (Parvo B19) and 3 x 10 1 to 1 x 10 9 (Hepatitis A) copies/ml Overall data 172 (Parvo B19 Virus); 176 (Hepatitis A Virus) Results determined for linear range and LoD: Linear range (copies/ml) Limit of detection (LoD 95) Parvo B19 Virus Hepatitis A Virus 2 x 10 2 to 5 x 10 6 3 x 10 3 to 1 x 10 9 68 copies/ml 119 copies/ml 10

Intra-assay, inter-assay, and lot-to-lot precision Standard deviations (SD) and coefficients of variations (CVs) were determined for dilution series within the linear range using Parvo B19 virus and Hepatitis A virus. To determine the intraassay precision, all data were produced in a single run. To determine the inter-assay precision three runs were performed by different operators, on different instruments, in different labs. Lot-to-lot precision was determined using six different lots. The experimental setup to perform precision analysis is shown below: Kit type MagNA Pure 96 DNA and Viral NA SV Kit Purification protocol Viral NA Universal SV Sample type EDTA plasma Sample input volume 200 µl Elution volume 50 µl Dilution series Replicates 8 Data points on LightCycler 480 Instrument 1 x 10 3 to 1 x 10 6 copies/ml for both Parvo B19 and Hepatitis A virus Intra-run: 32 Inter-run: 96 Lot-to-lot: 160 Results for intra-assay, inter-assay, and lot-to-lot precision: CP CP 30 28 26 24 22 20 18 16 32 30 28 26 24 22 20 18 Precision Parvo B19 Virus Intra-assay Inter-assay Lot-to-lot 1 x 10 6 1 x 10 5 1 x 10 4 1 x 10 3 Precision Hepatitis A Virus Intra-assay Inter-assay Lot-to-lot 1 x 10 6 1 x 10 5 1 x 10 4 1 x 10 3 G Figure 6: The qpcr results are highly reproducible (CV <2%) for intra-run, inter-run, and lot-to-lot precision. Performance Data 13 11

Ordering Information MagNA Pure 96 Instrument, Kits, Consumables and Accessories 1. Instrument Product Name Cat. No. Contents MagNA Pure 96 Instrument 06 541 089 001 instrument, control unit, software, accessories 2. Reagent Kits Product Name Cat. No. Kit Contents MagNA Pure 96 DNA and Viral NA Small Volume Kit MagNA Pure 96 DNA and Viral NA Large Volume Kit MagNA Pure 96 Cellular RNA Large Volume Kit (The intended use of this kit is For life science research only. Not for use in diagnostic procedures. ) 06 543 588 001 3 x 192 purifications 06 374 891 001 3 x 96 purifications 05 467 535 001 3 x 96 purifications MagNA Pure 96 System Fluid (Internal) 06 430 112 001 2 containers MagNA Pure 96 System Fluid (External) 06 640 729 001 1 container MagNA Pure 96 External Lysis Buffer 06 374 913 001 100 ml MagNA Pure 96 Bacterial Lysis Buffer 06 374 921 001 20 ml MagNA Pure 96 DNA Tissue Lysis Buffer 06 640 702 001 200 ml 3. Consumables Product Name Cat. No. Kit Contents MagNA Pure 96 Filter Tips (1000 µl) 06 241 620 001 8 blisters with 5 trays à 96 tips MagNA Pure 96 Processing Cartridge 06 241 603 001 36 MagNA Pure 96 Output Plate 06 241 611 001 60 MagNA Pure 96 Sealing Foil 06 241 638 001 100 MagNA Pure 96 Internal Control Tube 06 374 905 001 150 (15 x 10) 11 12

4. Accessories Product Name Cat. No. Contents MagNA Pure 96 Drop Catcher 06 541 119 001 10 MagNA Pure 96 Reagent Loop Unit 06 541 127 001 1 MagNA Pure 96 Barcode Scanner 06 541 143 001 1 MagNA Pure 96 Tip Rack 06 541 151 001 1 MagNA Pure 96 Bottle Rack 06 541 178 001 1 MagNA Pure 96 Needle Set of 4 06 541 194 001 4 Needles MagNA Pure 96 Purification Rack 06 541 208 001 1 MagNA Pure 96 Reagent Rack 06 541 224 001 1 MagNA Pure 96 Waste Rack 06 541 259 001 1 MagNA Pure 96 Internal Waste Container 06 541 267 001 1 MagNA Pure 96 External Waste Container on request 1 MagNA Pure 96 Waste Cover 06 541 275 001 10 MagNA Pure 96 Plate Holder 06 541 283 001 1 MagNA Pure 96 LightCycler 480 Adapter 06 638 996 001 1 MagNA Pure 96 Archive Plate Adapter 4S 06 639 003 001 1 Roche Applied Science Service and Support Roche Applied Science is committed to providing innovative, high-quality instruments and reagents combined with excellent customer service. We provide powerful tools meeting the needs of life science researchers worldwide. To explore our products and services or to find a local representative, please visit www.roche-applied-science.com. Whether you need expert technical support, online access to comprehensive product information, convenient on-site product supply service and online ordering, or outstanding customer service to ensure accurate and timely product delivery, we provide a wealth of resources to help you achieve your research goals. Trademarks and disclaimers: Products are for in vitro diagnostic use, unless otherwise indicated. MAGNA PURE and LIGHTCYCLER are trademarks of Roche. All other product names and trademarks are the property of their respective owners. This information folder is not intended for use in the USA. Ordering Information 12 13