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Page 1: MagNA Pure 96 System - Roche · The MagNA Pure 96 System is a high-throughput instrument for automated nucleic acid purification. Typical run duration is less than one hour for 96

MagNA Pure 96 System Start here. Go anywhere.

Page 2: MagNA Pure 96 System - Roche · The MagNA Pure 96 System is a high-throughput instrument for automated nucleic acid purification. Typical run duration is less than one hour for 96

The MagNA Pure 96 System is a high-throughput instrument for automated nucleic acid purification. Typical run duration is less than one hour for 96 standard volume samples. Experience high throughput automation combined with high performance while increasing your laboratory productivity to meet your changing needs.

• Isolate DNA, RNA, and viral nucleic acids from a wide range of starting materials.

• Simplify your workflow with pre-programmed protocols tailored to different sample requirements.

• Utilize proven magnetic glass particle technologies.

• Rely on eluates suitable for a broad range of genomic applications.

• Magnify your lab’s efficiency with seamless data management.

• Expand capacity for diverse day to day throughput needs.

Start here.

Go anywhere with confidence.

“The MagNA Pure 96 helps us to maximize staff productivity, decrease our turnaround times, and accommodate fluctuations in testing demands at the peak of respiratory virus season without making significant changes to staffing and workflows. Overall, we are very happy with the MagNA Pure 96 system and with our Roche partnership.”

Page 3: MagNA Pure 96 System - Roche · The MagNA Pure 96 System is a high-throughput instrument for automated nucleic acid purification. Typical run duration is less than one hour for 96

MagNA Pure 96 Reagent Kits Prefilled, barcoded, and ready-to use MagNA Pure 96 Kits are prefilled and ready-to-use reagent trays that can be easily loaded into racks, ensuring user ease and safety. These kits, as well as the consumables, are barcoded and read by the MagNA Pure onboard scanner for inventory check, loading errors, and process documentation.

Three kits that cover a large range of starting materials and targets

Reagents Target

Starting Material

Who

le b

lood

Plas

ma

Cell

Cultu

re

Seru

m

Body

flui

ds

Fres

h fro

zen

tissu

e

FFPE

tiss

ue

Swab

Stoo

l

Sput

um

MagNA Pure 96 DNA and Viral Nucleic Acid Small Volume Kit

Genomic DNA ● ● ● ●

Bacterial DNA ● ● ● ● ● ● ● ●

Viral DNA/RNA ● ● ● ● ● ● ● ●

MagNA Pure 96 DNA and Viral Nucleic Acid Large Volume Kit

Genomic DNA ● ● ●

Bacterial DNA ● ● ● ● ● ● ● ●

Viral DNA/RNA ● ● ● ● ● ● ● ●

Cell free NA ●

MagNA Pure 96 Cellular RNA Large Volume Kit* Total RNA ● ● ● ●

MagNA Pure 96 Software Intuitive user interfaceThe intuitive graphical user interface provides all instructions to operate the system, such as sample loading to run start. The software detects loading errors and provides information to the user for the appropriate corrective action.

* For life science research only. Not for use in diagnostic procedures.

C. Renee Webb, MT(ASCP)Manager, Molecular Laboratories

Texas Children’s Hospital

Page 4: MagNA Pure 96 System - Roche · The MagNA Pure 96 System is a high-throughput instrument for automated nucleic acid purification. Typical run duration is less than one hour for 96

Anatomy of a MagNA Pure 96 System Effortless purification, confidence from automation

Proven performance

� Over 20 years of successful magnetic bead technology

� High quality extract with reproducible and consistent yields

� GMP-manufactured and IVD registered

� Dedicated, experienced support and service teams

Simplified Workflow

� Ready-to-use prefilled reagents

� Minimal consumables

� On-board barcode scanning for inventory

� Streamlined kit offering that purify a variety of nucleic acids

� Intuitive graphical interface

Contamination Prevention

� UV lamp

� Drop catcher

� CO-RE Tip technology with stable lock-and-key fit which eliminates the risk of cross-contamination

Page 5: MagNA Pure 96 System - Roche · The MagNA Pure 96 System is a high-throughput instrument for automated nucleic acid purification. Typical run duration is less than one hour for 96

Accelerated Results

� 96 samples in less than one hour

� Parallel handling of all samples with 2 robotic arms

� Set-up in less than 5 minutes

Data Management

� Software with audit trail and user management

� LIMS host connectivity

Optimized Productivity

� Broad range of supported samples

� Pre-programmed protocols, including “Pathogen Universal” that extracts DNA and RNA from 10 common samples

� Eluate used for a variety of downstream applications

Minimized Handling Error

� Fully automated workflow

� Error detection with corrective action guidance

� Deck and volume surveillance

� Barcoding of kits and consumables

Page 6: MagNA Pure 96 System - Roche · The MagNA Pure 96 System is a high-throughput instrument for automated nucleic acid purification. Typical run duration is less than one hour for 96

Flexibility for optimized productivityEfficient Purification

Experiment detailsKit: MagNA Pure 96 DNA and Viral NA SV Kit

Protocol: SV Blood protocol

Sample: Whole blood with various white blood cell counts ( 3700, 5800, 10600 K/µL)

DNA was measured with the UV-spectrophotometer. The alignment of the duplicate curves for the varying cell count indicates reproducibility and scalability of the MagNA Pure 96 Instrument.

Flexibility along with convenience

A variety of targets from a wide range of sample types can be extracted efficiently on the MagNA Pure 96 System using one protocol, one kit, and within the same run as indicated by the crossing points detected on the Roche LightCycler® 480 Real-Time PCR Instrument.

Experiment detailsKit: MagNA Pure 96 DNA and Viral NA LV KitPretreatment: As described in Instructions for Use

Protocol: Pathogen Universal 1000

Sample: EDTA plasma, throat wash, swab, cerebrospinal fluid, bronchoalveolar lavage

Pathogen Spike-in: Hepatitis A virus (RNA virus), Parvo B19 virus (DNA virus), Staphylococcus aureus and Enterococcus faecalis (gram positive bacteria) , β-globin (control)

40.00

35.00

30.00

25.00

20.00

15.00

10.00

5.00

0.00Plasma Throat Swab CSF BAL

Cro

ssin

g Po

int

Hep A Parvo B19 S. aureus E. faecalis βGlobin

“My lab techs have been so happy with the transition to the MagNA Pure 96. Setup takes less than 5 minutes and is very easy. We have moved almost all of our extractions to this instrument, and – across our sample types – it gives us highly consistent eluates.”

2.0

1.8

1.6

1.4

1.2

1

0.8

0.6

0.4

0.2

0220 230 240 250 260 270 280 290 300 310 320

Abs

orba

nce

(AU

)

Wavelength (nm)

10600 K/µl 5800 K/µl 3700 K/µl

β-globin

Page 7: MagNA Pure 96 System - Roche · The MagNA Pure 96 System is a high-throughput instrument for automated nucleic acid purification. Typical run duration is less than one hour for 96

Increase efficiency in pathogen detection The Roche workflow makes pathogen detection reliable and consistent. The high throughput MagNA Pure 96 System dramatically speeds up extraction by allowing different sample types to be supported by the same kit and protocols which enables faster downstream analysis. Increase efficiency even further with multiplex qPCR and assay panels offered by TIB MolBiol which can be run the LightCycler® 480 instrument.

Experiment detailsKit: MagNA Pure 96 DNA and Viral NA SV Kit Pretreatment: As described in IFU

Protocol: Pathogen Universal

Sample: Serum (Parasite panel), Stool (Gastro panel), and Swab (Influenza panel)

Parasite Panel Channel Cp Std HitsE. Histrolytica 440-488 29.6 0.1 2/2Giardia 465-510 30.0 0.0 2/2Dientamoeba 533-580 29.7 0.1 2/2Cryptosporidium 533-610 29.6 0.1 2/2Blastocystis 533-640 30.1 0.1 2/2

Gastro Panel Channel Cp Std HitsNorovirus GG2 465-510 35.1 0.2 2/2Rotavirus A 533-580 33.0 0.0 2/2Adenovirus V 533-610 29.2 0.0 2/2

Flu Panel Channel Cp Std HitsInfluenza A 465-510 33.6 0.2 2/2Influenza B 533-580 33.7 0.5 2/2

Safedin Sajo Beqaj, Ph.D., HCLD, CC (ABB) Scientific Director

Pathology, Inc.

310.540

280.540

250.540

230.540

190.540

160.540

130.540

100.54

70.540

40.540

10.5405 10 15 20 25 30 35 40 45

Cycles

Fluo

resc

ence

(44

0-48

8)

E. Histolytica

Amplification Curves

5 10 15 20 25 30 35 40 455 10 15 20 25 30 35 40 45

54.890 49.890 44.890 39.890 34.890 29.890 24.890 19.890 14.890 9.890 4.890

-0.1105 10 15 20 25 30 35 40 45

Cycles

Fluo

resc

ence

(49

5-51

0)

Giardia

Amplification Curves84.465

76.465

68.465

60.465

52.465

44.465

36.465

28.465

20.465

12.465

4.4655 10 15 20 25 30 35 40 45

Cycles

Fluo

resc

ence

(53

3-58

0)

Dientamoeba

Amplification Curves84.465

76.465

68.465

60.465

52.465

44.465

36.465

28.465

20.465

12.465

4.4655 10 15 20 25 30 35 40 45

Cycles

Fluo

resc

ence

(53

3-58

0)

Dientamoeba

Amplification Curves

Dientamoeba62.552

56.552

50.552

44.552

38.552

32.552

26.552

20.552

14.552

8.552

2.5525 10 15 20 25 30 35 40 45

Cycles

Fluo

resc

ence

(53

3-61

0)

Amplification Curves

Cryptosporidium60.314

54.314

48.314

42.314

36.314

30.314

24.314

18.314

12.314

6.314

0.3145 10 15 20 25 30 35 40 45

Cycles

Fluo

resc

ence

(53

3-64

0)

Amplification Curves

Blastocystis

34.438

31.438

28.438

25.438

22.438

19.438

16.438

13.438

10.438

7.438

4.438

1.438

Cycles

Fluo

resc

ence

(46

5-51

0)

5 10 15 20 25 30 35 40 45

GG2

Amplification Curves13.130 12.130 11.130 10.130 9.130 8.130 7.130 6.130 5.130 4.130 3.130 2.130 1.130 0.130

Cycles

Fluo

resc

ence

(53

3-58

0)

5 10 15 20 25 30 35 40 45

RotaA

Amplification Curves16.944

15.944

13.944

12.944

10.944

9.944

7.944

6.944

4.944

3.944

1.944

0.444

Cycles

Fluo

resc

ence

(53

3-61

0)

5 10 15 20 25 30 35 40 45

AdV

Amplification Curves8.908

8.108

7.308

6.508

5.708

4.908

4.108

3.308

2.508

1.708

0.908

0.108

Cycles

Fluo

resc

ence

(46

5-51

0)

5 10 15 20 25 30 35 40 45

InfA

Amplification Curves26.793

24.293

21.793

19.293

16.793

14.293

11.793

9.293

6.793

4.293

1.793

Cycles

Fluo

resc

ence

(53

3-58

0)

5 10 15 20 25 30 35 40 45

InfB

Amplification Curves

Parasite Panel (Serum)

Gastro Panel (Stool) Flu Panel (Swab)

Page 8: MagNA Pure 96 System - Roche · The MagNA Pure 96 System is a high-throughput instrument for automated nucleic acid purification. Typical run duration is less than one hour for 96

High throughput and scalabilityPrevention of contamination Three runs (each with 48 positive spiked plasma samples and 48 negative samples arranged in a checkerboard pattern) were extracted on the MagNA Pure 96 System and then analyzed on the LightCycler® 480 System. No cross-contamination was found.

Highly reproducible results qPCR results from MagNA Pure 96 extracted samples are highly reproducible (CV <2%) for intra-run and inter-run, and show reagents' lot-to-lot consistency.

Experiment detailsKit: MagNA Pure 96 DNA and Viral NA LV Kit

Protocol: Large Volume Protocol (500µL)

Sample: EDTA Plasma

Pathogen: Parvo B19 at 5 x 10^7 copies/mL (=10^6 above detection limit)

0,616 0,566 0,516 0,466 0,416 0,366 0,316 0,266 0,216 0,166 0,116 0,066 0,016

-0,034 10 20 30 40

Fluo

resc

ence

(48

3-64

0)

Cycles

Amplification Curves

Negative Positive

2 3 4 5 6 7 8 9 10 11 12 13

A

B

C

D

E

F

G

H

Experiment detailsKit: MagNA Pure 96 DNA and Viral NA SV Kit

Protocol: Viral NA Universal SV

Sample: EDTA Plasma

Intra-assay – single run, 8 replicatesInter-assay – 3 runs by different operators on different instruments in different labsLot-to lot – 6 different lots32

30

28

26

24

22

20

181x106 1x105 1x104 1x103

CP

Precision - Hepatitis A Virus

Intra-assayInter-assayLot-to-lot

30

28

26

24

22

20

18

161x106 1x105 1x104 1x103

CP

Precision - Parvo B19 Virus

Intra-assayInter-assayLot-to-lot

Page 9: MagNA Pure 96 System - Roche · The MagNA Pure 96 System is a high-throughput instrument for automated nucleic acid purification. Typical run duration is less than one hour for 96

Growing with your needsScale with ease Go anywhere with scalability for your lab’s growth. The MagNA Pure 96 Instrument is significantly faster than two other competitor brands. When considering daily, monthly and yearly capacity needs, the MagNA Pure 96 Instrument provides increased ability to meet growth and testing fluctuations.1,2

Beyond extraction Unlock more of the answers you need with the new 4 mL volume protocol for circulating cell-free nucleic acids (cfNA) on the MagNA Pure 96 System by preferentially isolating smaller size fragments. Adapt to fluctuating demand with the only platform to have the scalability of up to 48 cfNA extractions in one run and rely on pre-optimized cfNA protocols to address specific eluate needs for a broad range of downstream genomic applications, including real-time PCR, arrays, and next-generation sequencing.

Roche

Competitor Q

Competitor B

0 100 200 300 400

Buccal Swab

Minutes

Roche

Competitor Q

Competitor B

0 100 200 300 400

Whole Blood

Minutes

1000

800

600

400

200

100

0

Test

ing

Cap

acity

(In

Sam

ples

)384

96

10k

8k

6k

4k

2k

1k

0

7,680

1,920

100k

80k

60k

40k

20k

10k

0

92,160

23,040

Daily Monthly Yearly

(1) Source: Extraction Instrument Comparison; Clinical Lab Consulting, 2016.(2) Assumes 8 work hour day and whole blood extraction protocol

Experiment detailsKit: MagNA Pure 96 DNA and Viral NA LV Kit Pretreatment: MagNA Pure cfNA Buffer Set

Protocol: cfNA ds 4000

Sample: EDTA Plasma

Spike in: DNA Ladder (0.05, 0.15, 0.3, 0,5, 0.766, 1, 1.5, 2, 3, 5, 10kb)

Intra-assay – single run, 8 replicatesInter-assay – 3 runs by different operators on different instruments in different labsLot-to lot – 6 different lots

(FU)

120

100

80

60

40

20

0

-20 35 100 200 300 400 600 2000 10380

Fluo

resc

ence

Uni

ts

Fragment Size (base pairs)

Plasma only

Plasma with MagNA Pure cfNA Buffer Set

Bioanalyzer data demonstrates a shift in extraction size capture with the MagNA Pure 96 DNA and Viral NA LV Kit (dark blue) and when MagNA Pure cfNA Buffer Set is used to enhance small fragment isolation (light blue). Enhance your studies in the genomic world with new protocols and solutions now offered on the MagNA Pure 96 System.

Roche Competitor Q

Page 10: MagNA Pure 96 System - Roche · The MagNA Pure 96 System is a high-throughput instrument for automated nucleic acid purification. Typical run duration is less than one hour for 96

The MagNA Pure 96 System family ensures purity, reproducibility, and laboratory efficiency obtained only by automated bead-based extraction. Whether your lab extracts just a few samples or thousands in one day, the MagNA Pure family has a fully automated extraction to meet your scalable needs.

From low throughput days • Simplified sample preparation for dramatic reduction

of handling errors

• Preloaded protocols for a broad range of sample types

• Pre-filled and barcoded reagent kits

• Intuitive software and guidance

To high demand times Expand throughput and automation with Roche Liquid Handling which combines primary sample handling and PCR setup in one pipetting instrument.

MagNA Pure 24 System 1-24 Samples | Not available for sale

Roche Liquid Handling Sample Handling and PCR Setup

Coming in 2017

Start here.

Page 11: MagNA Pure 96 System - Roche · The MagNA Pure 96 System is a high-throughput instrument for automated nucleic acid purification. Typical run duration is less than one hour for 96

MagNA Pure 96 SystemTechnical Specifications

GeneralConfiguration Benchtop standalone instrument with separate control unitNumber of samples 1 to 96 reactions per runSample input volume 50 µL to 1 mL

Up to 4 mL for Plasma sampleElution volume 50 to 200 µLRun time Approximately 50 to 90 minutes depending on protocolSetup time Approximately 5 minutesRegulatory label For in vitro diagnostic use. Compliant with IVD directive 98/79/EC

Software and ConnectivityTraceability 21CFR part 11 (subsection B), Audit trail, Process monitoring, User guidanceData export *.xml, LightCycler® sample input file in csv format (*.txt)Interfaces USB, LAN 10/100/1000 Base T, LAN 10/100 Base

ConnectivityLIMS (e.g., via HL7 transfer protocol), Bidirectional file sharing, remote Roche Service with Axeda

HardwareDimensions W x D x H: 136 x 81.5 x 100 cmWeight 235 kgProcess parallelization and speed Two robotic heads: (1) Reagent head pipetting arm with four individually

controlled fluid channels to transfer reagents and (2) 96-nozzle process head to transfer and process samples in parallel.

Contamination control Drop catcher, UV Lamp, dual robotic arm engineering

Kits and ApplicationsReagent design Pre-filled, ready-to-useUnopened kit storage +15 to +25°CKit re-use Up to 28 days after first useIsolation principle Magnetic glass particle technologyNucleic acids DNA, tNA, viral NA, total RNA, cell-free NA

Supported sample typesWhole blood, plasma, serum, fresh-frozen tissue, FFPE tissue, cultured cells, urine, swabs, sputum, CSF, BAL, stool

Protocols >30

Go Anywhere.

Page 12: MagNA Pure 96 System - Roche · The MagNA Pure 96 System is a high-throughput instrument for automated nucleic acid purification. Typical run duration is less than one hour for 96

All MagNA Pure 96 Kits, Consumables, and Accessories are for in vitro diagnostic unless otherwise noted.* For life science research only. Not for use in diagnostic procedures.† For general laboratory use.

MAGNA PURE and LIGHTCYCLER are registered trademarks of Roche. All other product names and trademarks are the property of their respective owners.

© 2016 Roche Molecular Systems, Inc. All rights reserved.

Published by Roche Molecular Systems, Inc 4300 Hacienda Drive Pleasanton, CA 94588 USA

Product Name Catalog # Content1. Instrument

MagNA Pure 96 Instrument 06 541 089 001Instrument, control unit, software, accessories

Ordering informationMagNA Pure 96 Instrument, Kits, and Consumables

2. Reagent Kits and Lysis BuffersMagNA Pure 96 DNA and Viral NA LV Kit 06 374 891 001 Up to 288 isolationsMagNA Pure 96 DNA and Viral NA SV Kit 06 543 588 001 Up to 596 isolationsMagNA Pure 96 Cellular RNA LV Kit* 05 467 535 001 Up to 288 isolationsMagNA Pure 96 System Fluid (Internal) 06 430 112 001 2 containersMagNA Pure 96 System Fluid (External) 06 640 729 001 1 containerMagNA Pure 96 External Lysis Buffer 06 374 913 001 100 mLMagNA Pure 96 Bacterial Lysis Buffer 06 374 921 001 20 mLMagNA Pure 96 DNA Tissue Lysis Buffer 06 640 702 001 200 mLMagNA Pure cfNA Buffer Set NEW † 07 794 398 001 Up to 96 isolations

3. ConsumablesMagNA Pure 96 Processing Cartridge 06 241 603 001 36MagNA Pure 96 Output Plate 06 241 611 001 60MagNA Pure Filter Tip 1000µl 06 241 620 001 8x5MagNA Pure Sealing Foil† 06 241 638 001 100MagNA Pure 96 Internal Control Tube 06 374 905 001 150 (15x10)

For more information or general inquiries, or to obtain updated protocols, please contact your local Roche representative or visit magnapure96.com