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Phone/Fax z +91612 2283287,+ 91612 2283288

Public otice Inviti aims/Obiections rdin Procurement of

COVID Test Kit for ltull tomated DNA/RN Bx n Mach

Roche" M A Pure- BMSIC Patna

Proprietarv Basis.

BMSICL Patna is going to procure covlD Test Kit for Fully Automated DNA/RNA Extraction

Machine (Make- RochelModel- MagNA Pure-96) on Proprietary basis' The proposal subrnitted by

M/s Roche Diagnostics India Pvt. Ltd. and its Propriety Article Certificate have been attached &

uploaded on website of BMSICL.

.l-lre above docurnents are being uploaded for open information to sLrbmit Clairns/Objectiotts, if any

fi"om a.y Manufacturer/Distributoi regarding pioprietary nature_ and pricing of the above mentiottcd

kits/con"sumables within 7 days front the date of publication o1'this notice'

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emaif to md:b-msigl:bih@nic'in or gmproc'bmsicl@Smail'com or

bmsicl.equipmen@gmail.com, failing wlricli it will be presumed that no one is having arry

Clairns/Otiection to-oTfer regarding this and the case will be decided on merits'

Ad't.t\6-1'*'GM (Procurement)

BMSICL. Patna

Page 1 of 1

MagNA Pure 96 System

Start here. Go anywhere.

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.”

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

Wh

ole

blo

od

Pla

sma

Cell

Cu

lture

Seru

m

Bo

dy

fluid

s

Fresh

fro

zen

tis

sue

FFP

E t

issu

e

Sw

ab

Sto

ol

Sp

utu

m

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 interface

The 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

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

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

Flexibility for optimized productivityEfficient Purification

Experiment details

Kit: 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 details

Kit: MagNA Pure 96 DNA and Viral NA LV Kit

Pretreatment: 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 P

oin

t

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

Ab

so

rba

nc

e (

AU

)

Wavelength (nm)

10600 K/µl 5800 K/µl 3700 K/µl

β-globin

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 details

Kit: 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 Hits

E. Histrolytica 440-488 29.6 0.1 2/2

Giardia 465-510 30.0 0.0 2/2

Dientamoeba 533-580 29.7 0.1 2/2

Cryptosporidium 533-610 29.6 0.1 2/2

Blastocystis 533-640 30.1 0.1 2/2

Gastro Panel Channel Cp Std Hits

Norovirus GG2 465-510 35.1 0.2 2/2

Rotavirus A 533-580 33.0 0.0 2/2

Adenovirus V 533-610 29.2 0.0 2/2

Flu Panel Channel Cp Std Hits

Influenza A 465-510 33.6 0.2 2/2

Influenza 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

Flu

ore

sc

en

ce

(4

40

-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

Flu

ore

sc

en

ce

(4

95

-51

0)

Giardia

Amplification Curves

84.465

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

Flu

ore

sc

en

ce

(5

33

-58

0)

Dientamoeba

Amplification Curves

84.465

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

Flu

ore

sc

en

ce

(5

33

-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

Flu

ore

sc

en

ce

(5

33

-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

Flu

ore

sc

en

ce

(5

33

-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

Flu

ore

sc

en

ce

(4

65

-51

0)

5 10 15 20 25 30 35 40 45

GG2

Amplification Curves

13.130

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

Flu

ore

sc

en

ce

(5

33

-58

0)

5 10 15 20 25 30 35 40 45

RotaA

Amplification Curves

16.944

15.944

13.944

12.944

10.944

9.944

7.944

6.944

4.944

3.944

1.944

0.444

Cycles

Flu

ore

sc

en

ce

(5

33

-61

0)

5 10 15 20 25 30 35 40 45

AdV

Amplification Curves

8.908

8.108

7.308

6.508

5.708

4.908

4.108

3.308

2.508

1.708

0.908

0.108

Cycles

Flu

ore

sc

en

ce

(4

65

-51

0)

5 10 15 20 25 30 35 40 45

InfA

Amplification Curves

26.793

24.293

21.793

19.293

16.793

14.293

11.793

9.293

6.793

4.293

1.793

Cycles

Flu

ore

sc

en

ce

(5

33

-58

0)

5 10 15 20 25 30 35 40 45

InfB

Amplification Curves

Parasite Panel (Serum)

Gastro Panel (Stool) Flu Panel (Swab)

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 details

Kit: 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

Flu

ore

sc

en

ce

(4

83

-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 details

Kit: MagNA Pure 96 DNA and Viral NA SV

Kit

Protocol: Viral NA Universal SV

Sample: EDTA Plasma

Intra-assay – single run, 8 replicates

Inter-assay – 3 runs by different operators

on different instruments in different labs

Lot-to lot – 6 different lots32

30

28

26

24

22

20

181x106 1x105 1x104 1x103

CP

Precision - Hepatitis A Virus

Intra-assay

Inter-assay

Lot-to-lot

30

28

26

24

22

20

18

161x106 1x105 1x104 1x103

CP

Precision - Parvo B19 Virus

Intra-assay

Inter-assay

Lot-to-lot

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

Testi

ng

Ca

pa

cit

y (

In S

am

ple

s)

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 details

Kit: 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 replicates

Inter-assay – 3 runs by different operators

on different instruments in different labs

Lot-to lot – 6 different lots

(FU)

120

100

80

60

40

20

0

-20 35 100 200 300 400 600 2000 10380

Flu

ore

sc

en

ce

Un

its

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

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.

MagNA Pure 96 SystemTechnical Specifications

General

Configuration Benchtop standalone instrument with separate control unit

Number of samples 1 to 96 reactions per run

Sample input volume 50 µL to 1 mL

Up to 4 mL for Plasma sample

Elution volume 50 to 200 µL

Run time Approximately 50 to 90 minutes depending on protocol

Setup time Approximately 5 minutes

Regulatory label For in vitro diagnostic use. Compliant with IVD directive 98/79/EC

Software and Connectivity

Traceability 21CFR part 11 (subsection B), Audit trail, Process monitoring, User guidance

Data 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

Hardware

Dimensions W x D x H: 136 x 81.5 x 100 cm

Weight 235 kg

Process 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 Applications

Reagent design Pre-filled, ready-to-use

Unopened kit storage +15 to +25°C

Kit re-use Up to 28 days after first use

Isolation principle Magnetic glass particle technology

Nucleic 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.

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 # Content

1. 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 Buffers

MagNA Pure 96 DNA and Viral NA LV Kit 06 374 891 001 Up to 288 isolations

MagNA Pure 96 DNA and Viral NA SV Kit 06 543 588 001 Up to 596 isolations

MagNA Pure 96 Cellular RNA LV Kit* 05 467 535 001 Up to 288 isolations

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

MagNA Pure cfNA Buffer Set NEW † 07 794 398 001 Up to 96 isolations

3. Consumables

MagNA Pure 96 Processing Cartridge 06 241 603 001 36

MagNA Pure 96 Output Plate 06 241 611 001 60

MagNA Pure Filter Tip 1000µl 06 241 620 001 8x5

MagNA Pure Sealing Foil† 06 241 638 001 100

MagNA 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