Elecsys® with ECL technologyStill light years ahead

The unique technology behind Elecsys®

immunoassaysECL – ElectroChemiLuminescenceECL technology is Roche’s highly innovative detection technology for heterogeneous immunoassays.Since the launch of the first Elecsys 2010 analyzer for small to mid-range laboratories in 1996, the extraordinary success story of the Elecsys platform and ECL technology has continued to set the standard in immunochemistry. More than 35,000 instruments* testify to the outstanding success of Elecsys systems, assays and the ECL technology. Every second, 60 results are reported in laboratories all over the world, amounting to more than 1.9 billion tests in 2016.

The Elecsys 2010 analyzer and its successor systems, MODULAR E170, cobas e 601, cobas e 602, cobas e 801 modules and cobas e 411 analyzer are designed to reduce the complexity in laboratory operation and provide efficient and compatible solutions for network cooperation. The cobas e modules are part of the cobas® modular platform which includes cobas 4000 and cobas 6000 analyzer series and cobas 8000 modular analyzer series. This concept is based on a common architecture that delivers tailor-made solutions for diverse workload and testing requirements.

Designed for the professional IVD user, Elecsys with ECL technology combines innovative technologies with accurate, precise and reliable patient results which contribute to better patient care.

* Status 2016

Fast, accurate, precise and reliable patientresultsThe power of ECL technology

Elecsys® diagnostic markers with advanced assay design• Robustness against interference (e.g. HAMA) due to a multidi-

mensional approach: blocking proteins, fragmented catcher or tracer antibodies or chimeric antibodies

• Reference-traceable results with high lot-to-lot stability allows for accurate long-term monitoring

• Unique reagent concept with ready-to-use, failsafe and conve-nient e-packs for consistent handling

• Consistently precise results across cobas® immunochemistry platforms based on standardized reagents and low system- immanent variability

ECL is a highly innovative technology with distinct advantages• Extremely stable non-isotopic label for long onboard stability

and economic use of reagents• High sensitivity for patient-friendly low sample volumes and fast

results due to short turnaround times• Broad measuring range for fewer repeats and a streamlined

workflow• High precision over the entire measuring range for reliable

results• Applicable for the detection of all analytes for a broad assay

menu including innovative markers

Broad and innovative assay menuECL immunoassay principle

The strong streptavidin-biotin bond is used to affix the anti-gen/antibody complex to a paramagnetic microbead

Several immunoassay types are feasible, including competitive, sandwich and bridge assays – even nucleic acid applications are possible.

The affinity of streptavidin to biotin is one of the strongest non-covalent interactions known in nature and is resistant to organic solvents, denaturants, detergents, proteolytic enzymes, and extremes of temperature and pH.

Paramagnetic microbeads enable a controlled capture and release of the antigen/antibody complex through the application of magnetic forces.

StreptavidinParamagneticbead

Biotin

Antigen

Antibody

Nucleic acid

The basic principle

Full control inside the measuring cellECL signal generation and detection

Magnetic bound/free separation: • The solution containing sample and reagents is aspirated into

the measuring cell. A magnetic field is applied, and the para-magnetic beads bind to the surface of the measuring cell.

• ProCell solution is introduced in order to separate the bound immunoassay complexes from the free remaining particles and to provide tripropylamine (TPA), which is essential for the ECL-reaction.

Magnet Flow channel

Magnetic microbeads with bound antigen-antibody complex

Unbound antibody(ruthenium-labeled)

Photo-multiplier

Counterelectrode

Working electrode

High on-board stability and economic usageof reagentsControlled reaction with voltage as trigger

The use of voltage eliminates problems associated with reagent adding/mixing and ensures a precisely controlled reaction.

Controlled reaction with voltage as reaction trigger: To start the reaction, voltage is applied between the working and counter electrode, and an electrical field is created, ensuring a precisely controlled and timed reaction.

Highly stable reactants: Two electrochemically active substances, the ruthenium complex and the TPA, are involved in the reaction that leads to the emission of light. Ruthenium and TPA are non-isotopic and highly stable at base state. Only when voltage is applied and the labeled compound is repeatedly excited do the reactants begin emitting photons.

ECL

inte

nsit

y [c

ount

s]

Ap

plie

d vo

ltag

e [V

]

Time

40,000

30,000

20,000

10,000

50,000

60,000

0.4

0.8

1.2

1.6

00

ECL

inte

nsit

y [c

ount

s]

Ap

plie

d vo

ltag

e [V

]

Time

40,000

30,000

20,000

10,000

50,000

60,000

0.4

0.8

1.2

1.6

00

ECL

inte

nsit

y [c

ount

s]

Ap

plie

d vo

ltag

e [V

]

Time [sec]

40,00030,00020,00010,000

50,00060,00070,000

0.4

0.8

1.2

1.6

80,000

000 0.2 0.4 0.6 0.8 1.0 1.2

ECL

inte

nsit

y [c

ount

s]

Ap

plie

d vo

ltag

e [V

]

Time [sec]

40,00030,00020,00010,000

50,00060,00070,000

0.4

0.8

1.2

1.6

80,000

000 0.2 0.4 0.6 0.8 1.0 1.2

ECL intensity applied voltage

ECL signal generation

excitedstate

e– e–

e–

Photon

H +

TPA

TPA R

TPA +R

Ruthenium label

Magnet+ Platinum electrode +

Ru 3+

excitedstate

base state

e– e–

e–

Photon

Ru 2+

H +

TPA

TPA R

TPA +R

Ru 2+

Ruthenium label

Magnet

TPA

PPP Photon

+ Platinum electrode +Magnet

+ Platinum electrode +

TPARu 2+

base state

Ru 2+ Ru 3+

Ru 2+

base state

Reaction phase-light generation

Consolidation of routine and esoteric parameters on one system due to high on-board reagent stability.

Enhanced sensitivity and broad measuringrangesCyclic amplification of the signal

The ECL process continuously regenerates the ruthenium label, enabling multiple signal cycles during measurement.

Precise, reproducible signal: Through cyclic amplification of the signal, a peak of light emission can be continuously repro-duced and accurately detected by a photomultiplier.

High sensitivity and broad measuring range: The resulting ECL reaction creates a signal response which is linear over more than six orders of magnitude.

Magnet

TPA

PPP Photon

+ Platinum electrode +

TPARu 2+

Magnet

TPA

PPP Photon

+ Platinum electrode +

TPA

base stateRu 2+

9 min

base state

Reaction phase-signal amplification

ECL intensity (counts)

70,000

50,000

30,000

0.00 0.20 0.40 0.60 0.80 1.00 1.20 0

0

Applied voltage (V)

Time (sec)

0.4

0.8

1.2

1.6

ECL signal generation

log (ECL intensity (counts))

The ECL signal response is linear overmore than 6 orders of magnitude

8

6

4

2

0-14 -12 -10 -8 -6 -4

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

AFP

[ng

/mL]

coba

s e

411

anal

yzer

AFP [ng/mL]cobas e 601 module

0

80

60

40

20

100

120

140

160

180

0 20 40 60 80 100 120 140 160 180

log

[E

CL

inte

nsit

y (c

ount

s)]

4321

5678

0-14 -12 -10 -8 -6 -4

ECL

inte

nsit

y [c

ount

s]

Ap

plie

d vo

ltag

e [V

]

Time [sec]

40,00030,00020,00010,000

50,00060,00070,000

0.4

0.8

1.2

1.6

80,000

000 0.2 0.4 0.6 0.8 1.0 1.2

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

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

Streamlined workflow through excellent low-end sensitivity paired with high precision over the entire measuring range.

Advantages of ECL technologyEnabling fast, precise, accurate and reliable patient results

Rapid response times• Short incubation times: 18 minutes for the

majority of assays• 9-minute STAT applications for

emergency samples

…for faster reporting of patient results

Precision & sensitivity• Superior low-end detection limits

• Excellent precision over the entire measuring range

…for accurate and precise patient resultsLow sample volume• High analytical sensitivity enables low

sample volumes• Patient-friendly 6-50 μl per test

…for fewer samples in the lab and a streamlined workflow

Controlled reaction• High on-board stability and long shelf-life

due to highly stable constituents

…for continuous availability of both, routine and esoteric parameters

Wide measuring range• Linear signal response over six orders of

magnitude

…for fewer dilutions and repetitions

ECL technology

Elecsys diagnostic markers and cobas®

modular platformPower play between reagents and systems

Proven Elecsys® performance• Advanced assay design based on state-of-the-art ECL technology

with low sample volumes, short turn around times, wide measuring ranges and high precision over the entire measuring range

• More than 40 years of assay development expertise• Premium quality of cobas analytical platforms with high safety

and reliability standards • Unique reagent concept with ready-to-use, failsafe & convenient

e-packs for consistent results across all analytical platforms

Precise and reliable results • High sensitivity in combination with a broad measuring range for

safe and reliable results• Robustness against interference (e.g. HAMA) due to a multi-

dimensional approach: blocking proteins, fragmented catcher or tracer antibodies or chimeric antibodies

• High lot-to-lot stability for accurate long-term monitoring• Consistently precise results across the platforms based on common

technologies and low system immanent variability

High workflow efficiency • Comprehensive assay menu including innovative markers• Outstanding serum work area consolidation power with more than

230 parameters • Broad system platform portfolio for every lab size with standardized

reagents across the platforms• Broad system platform offering for every lab size with consistent

patient results

ECL and Elecsys® Setting the standards in immunochemistry

Proven track record 1996 – 2016 20 years of excellence with 35,000 systems

The power of ECL technologyEnabling high-quality immunoassays for reliable patient results

Reagent and system competence > 100 high-quality assays since 1996

ECL and Elecsys

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

©2016 Roche

Roche Diagnostics International LtdCH-6343 RotkreuzSwitzerlandwww.cobas.com