Cobas e 411 Leaflet En

5/20/2018 Cobas e 411 Leaflet En

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cobas e 411 analyzerPeace of mind in immunology


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i l I li

Bayer Centaur Abbott Architect Roche Elecsys DPC Ilite 2000

MethodprecisionC

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cobas e 411 analyzerPeace of mind in immunology

Convenience

cobas epacks for convenient handling

cobas ereagent packs are liquid, ready-to-

use and simplify handling

All-in-one cassette packaging for each

parameter combined with calibrators stream-

lines logistics

Automatic pack opening/closing ensures

longer onboard stability

Programming-by-loading concept ensuresseamless, precise data handling

Data review screen provides quick result

traceability

Enhanced data review screen

Elecsys assay performance in external ring-trials

Electrochemiluminescence (ECL) reaction principle

Performance

9 min applications for speed and quality

Over 75 assays offer comprehensive cover-

age of 7 indication areas

High onboard stability and shelf-life allow

continuous availability of both routine and

esoteric parameters

Disposable tips and assay cups for reaction

eliminate risk of carryover

Integrated safety features ensure result

integrity

Confidence

ECL technology: The gold standard

High analytical sensitivity enables large mea-

suring ranges and low sample volume

Measuring ranges: Estradiol 4-4,300 pg/mL;Progesterone 0-6 ng/mL;

Total PSA 0-100 ng/mL;Sample Volume: b-hCG requires 10 L; 3rd Gen

TSH requires 50L Activation with voltage for a controlled reac-

tion allows high precision to avoid unneces-

sary repeats and reruns

Short incubation time enables the timely

availability of innovative applications

Magnet

Ru2base state

TPA

PPP Photon

Platinum Electrode

PTH Precision Monitoring

Reaction Phase - Measuring Cell


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Full workstation consolidation

The cobas e411 analyzer is designed

to deliver accurate results on account

of proven ECL technology

It consolidates routine endocrinologywith cardiac, cancer, bone and infec-

tious disease markers

Serum work area integration

Combined with the cobas c311 ana-

lyzer, the system processes up to 95%

of your serum work area workload

Work area management solutions inte-grate sample and data management

across systems

Seamless laboratory networking

As part of the cobas modular plat-

form, the cobas e411 analyzer offers

consistent results with other cobas e

systems

Universal reagent carriers and ana-

lytical components enable flexible

network solutions

1 CD-ROM, USB & printer ports enableefficient data management

4 cobastouchscreen user interface is

standardized to other cobas systems

7 Disposable tips and cups eliminatecarryover

8 Measuring cell provides unmatched

detection using ECL technology

9 Consumables and liquid waste are easily

accessible

2 Also available rack version with 75sample positions

5 18 channels enable use of up to 18parameters simultaneously

3 30 continuous random access sample

positions with STAT priority

6 Easy removal of disposables via solid

waste container

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COBAS, COBAS C, COBAS E, LIFE NEEDS ANSWERSand ELECSYS are trademarks of Roche.

Other brand or product names are trademarks

of their respective holders.

2010 Roche

Roche Diagnostics Ltd.

CH-6343 RotkreuzSwitzerland

www.roche.com

cobas e 411 analyzerTechnical specifications

System

Fully automated, continuous loading and random access system for immunoassay analysisbased on ECL technology. Available as a disk and rack system.

System components: Analytical module including touchscreen PC

Test Throughput Up to 86 tests/hr

Reagent concept cobas e reagent pack: Ready-to-use reagentsOnboard reagent capacity: 18 channels/reagent slots for up to 18 different assays

Evaporation protection: Automatic closure of reagent lids

Programmable parameters Max 60 assays denable via 2D-barcode including all necessary information (programming by loading)

Sample types Serum, Plasma, Urine and others

Onboard sample capacity Load/unload capacity: Disk: 30 samples Rack: 75 samples on 15 RD standard 5 position rack

Rack types: Routine, STAT, Control, Calibrator

STAT handling: Disk: Any unoccupied position on the sample disk Rack: Dedicated STAT port on rack feeder

Sample container types Primary tubes: 510 mL; 16x100, 16x75, 13x100, 13x75 mm

Sample cup: 2.5 mLCups on tube

Sample volume 10 to 50 L per test, depending on assay protocol

Sample probe Disposable tips for individual sample to avoid carry over; Sample clot detection; Liquid level detection

Sample barcode types PDF417, Code 128, Codabar (NW 7), Interleaved 2 of 5, Code 39

System interfaces Touchscreen PC, RS 232 serial interface, bi-directionalStandard PC ports (USB, ethernet, serial etc) for other communication devices

Sample database 2,000 result s for routine, STAT and controls

Test methods Pre-dened assay protocols (sandwich, competitive, titration)

Calibration methods 2-point calibration per lot or per cobas e reagent pack

QC methods Individual QC; Cumulative QC; Preventive QC after calibration

Rerun/repeat/reex Rerun, repeat and reex supported

Electrical requirements Power requirements: 100120 VAC 50/60 Hz single phase or 200240 VAC 50/60 Hz single phasePower consumption: 1,000 VA

Water/waste requirements Water supply: 3l container

Water quality: 10S/cm or 0.1 mega Ohm, bacteria-freeLiquid waste: 4l container with overow detection or direct drainWater consumption: Approx. 3l for 250 tests/approx. 12 mL/cycle

Regulatory compliance GS, CE, UL, C-UL, CB-report and cert icate

Operating condit ions Ambient temperature: 8 to 32C (64.4F to 89.6F)

Ambient humidity: 20% to 80%Noise output: 60 dbA (stand-by mode), 63 dbA (avg. during operation)

Physical dimensions Width: 120 to 170 cm (disk/rack)Depth: 73 to 95 cm (disk/rack)

Height: 56 cm (w/o PC unit)Weight: Approx. 170 kg (disk) and 210 kg (rack)


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cobas e 411 analyzerPeace of mind in immunochemistry

Powerful, precise and convenient, the cobas e 411 analyzer is the perfect immunochemistry testing solution for laboratories running

50 to 250 samples per day. At the heart of the analyzer, the highly innovative ElectroChemiLuminescence (ECL) technology delivers an

outstanding combination of high analytical sensitivity and wide measuring ranges at short turnaround times. With over 95 assays covering

more than 7 indication areas, the cobas e 411 analyzer uses the same convenient cobas e pack reagent format as all cobas e immunoassaysystems. This standardizes patient results, which is crucial for integrated laboratory networks. Together with the cobas c 311 clinical

chemistry analyzer, it provides a comprehensive serum work area solution.

Powerful testing capabilities

Flexible system offering to fit the laboratorys workflow

(cobas e 411 analyzer available as disk and rack system)

Broad test menu with over 95 assays including innovative markers,

e.g. HE4 and hGH

9 minute STAT applications including Troponin, CK-MB, Myoglobin,

-hCG and PTH provide unmatched response times

Designed for hospitals, emergency laboratories and clinics with

workloads of up to 250 samples per day with up to 86 tests/hour

Unmatched performance

ECL technology

High sensitivity for patient-friendly low sample volumes and fast results

Broad measuring range for fewer repeats and a streamlined workow

High precision over the entire measuring range for reliable results

Intuitive, convenient and connected

Compact sized benchtop analyzer

Common intuitive user interface

Electronic updates and downloads via cobase-services ensureseamless error-free data handling

Work area management solutions integrate sample and data management

across systems

COBAS, COBAS C, COBAS E and LIFE NEEDS ANSWERS are tr ademarks of Roche.

2012 Roche

Figure 1: cobas e411 analyzer (disk system) Figure 2: cobas e411 analyzer (rack system)


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cobas e 411 analyzerComprehensive cobas diagnostic markers

ECL signal response is linear over more than 6 orders of magnitude

Linear ECL signal generation covering more than six orders of

magnitude

Over 95 assays available covering more than 7 indication areas

9 minute STAT applications for rapid emergency sample response

times including Troponin, CK-MB, Myoglobin, -hCG and PTH

References

1. Elecsyswith ECL technology Still light years ahead. Roche internal brochure from 2011, Mat. Nr. 06528481001.

2. cobas e 411 analyzer vs. cobas e 601 analyzer, external correlation data. Data on le.

Figure 3: Linearity of the ECL signal response over a broad range ensures for highsensitivity and broad measuring ranges 1

The cobas e411 analyzer uses the universal cobas epacks. As a

consequence, all results are standardized across the entire cobas

platform and can be transferred easily across laboratory networks

Result standardization across the cobas platform

cobase411analyzer[ng/mL]

cobas e 601 module [ng/mL]

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0

0 10 20 30 40 50 60 70 80 90 100

Figure 4: CEA method comparison2

P/B regression

Y = 1.018 * X 0.006md(95) = 0.733N = 96 r = 0.9995t = 0.9439

COBAS, COBAS E, LIFE NEEDS ANSWERS and ELECSYS are t rademarks of Roche.

2012 Roche

log

[ECLintensity(counts)]

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-14 -12 -10 -8 -6 -4

log [(Ru/bpy) )/M]2+3


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cobas e 411 analyzerConvenient, error-free handling

Convenient operation and reliable results

30 sample positions (disk system) and 75 sample positions (rack system)

with continuous random access and exible STAT priority settings

Disposable tips and cups for individual sample pipetting for carry-over

free operation

Electronic updates and downloads via cobase-services ensure seamless,

error-free data handling

Smart reagent concept

Unique, ready-to-use cobasereagent packs deliver maximum

handling convenience and minimize logistical efforts

Flexible disease panel testing with maximum on-board capacity

of 18 parameters

Automatic pack opening and closing prevents evaporation and

ensures long onboard stabilities

COBAS, COBAS E and LIFE NEEDS ANSWERS are trademarks of Roche.

2012 Roche

Figure 5: cobas e411 analyzer (disk system)

Figure 6: Maximum handling convenience


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cobas e 411 analyzerIntelligent design for maximum up-time

COBAS, COBAS C, COBAS E and LIFE NEEDS ANSWERS are tr ademarks of Roche.

2012 Roche

Robust design for reliable performance

Sample clot detection by pressure sensor enables consistent results

without disrupting workflow

Proven Hitachi instrument reliability

Comprehensive serum work area integration

Combined with the cobas c 311 analyzer, the system can process up

to 95% of serum work area workloads with a capacity of up to

250 samples/day

Work area solutions integrate sample and data management across

systems to improve delivery of information and laboratory efciency

Complete SWA

(Serum Work Area)

cobas c 311 analyzercobas e 411 analyzer

Figure 7: Proven Hitachi instrument reliability ensures maximum system up-time


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cobas4000 analyzer seriescobas e411 assay menu

Thyroid function Tumor markers Infectious diseases

Anti-TG AFP Anti-HAV total

Anti-TPO CA 125 II Anti-HAV IgMAnti-TSHR CA 15-3 Anti-HBc

Calcitonin 1 CA 19-9 Anti-HBc IgM

FT3 CA 72-4 Anti-HBe

FT4 CEA Anti-HBs

T3 CYFRA 21-1 Anti-HCV

T4 free PSA HBeAg

T-Uptake NSE HBsAg

Tg total PSA HBsAg confirmatory

Tg hs 1 HBsAg quantification

TSH CMV lgG

Cardiac CMV lgM

CK-MB (mass) CMV IgG Avidity 1

Fertility / hormones CK-MB (mass) STAT HSV-11

ACTH Digoxin HSV-2 1

C peptide Digitoxin HIV Antigen

Cortisol Myoglobin HIV Antigen confirmatory

DHEA-S Myoglobin STAT HIV combi

Estradiol NT-proBNP HIV combi PT 1

FSH Troponin T Rubella IgG

hCG+b Troponin T hs Rubella IgM

hCG STAT Troponin T hs STAT Toxo IgG

Insulin Troponin T STAT Toxo IgM

LH

Progesterone

Prolactin

SHBG

Testosterone


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COBAS, COBAS E and LIFE NEEDS ANSWERS

are trademarks of Roche.

2010 Roche

Roche Diagnostics Ltd.

CH-6343 Rotkreuz

Switzerland

www.roche.com

Maternal care Anemia Bone markers

free bhCG Ferritin b-CrossLaps

PAPP-A Folate Vitamin D3 (25-OH)

PlGF RBC Folate Intact PTH

sFLT-1 Vitamin B12 N-MID Osteocalcin

P1NP

PTH STAT

Rheumatoid Arthritis Critical care

Anti-CCP IL6

BRAHMS PCT Others

S100 IgE

1Assays currently under development

Last Update 02/2010

Cobas e 411 Leaflet En

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