Adaltis S.r.l. YOUR LABORATORY ON A FINGERTIP April 2011 April 2011.

Adaltis S.r.l. Adaltis S.r.l. YOUR LABORATORY ON A FINGERTIPYOUR LABORATORY ON A FINGERTIP

April 2011April 2011

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System DescriptionSystem Description

Eclectica™ is a fully automated bench top analyzer able to perform, in an unique instrument, ImmunoAssay (IA) &Clinical Chemistry (CC) tests by using dedicated reagents.

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Instrument DescriptionInstrument Description

EclecticaTM is:very small-sized: 82 cm wide, 66 cm deep, 54 cm highhighly compact: all in 0.54 m2

no hydraulic or wall connections are required

EclecticaTM is suitable for laboratories of different dimensions and can be easily placed on every lab bench

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Instrument DescriptionInstrument Description

Thermal printer (real time results)

Keyboard with trackball

Protected working area:Reagent carrouselIA controls and Stds carrouselSample Plate Reaction plateDispensing & washing devicesReading chamber

Waste tank Common Reagents Drawer

Touch screen

Smart card readerUSB port

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Immunoassay: method descriptionImmunoassay: method description

ECLECTICA™ uses a well-tested immunoreaction

scheme based on immunoassays with magnetic

particles. The separation method is so versatile that it

allows to perform different assay schemes with the

same separation reagent:

Direct Immunoenzymatic Assay (IEMA)

Competitive Immunoenzymatic Assay (EIA)

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Immunoassay: method descriptionImmunoassay: method description

Immunocomplex formation (first incubation @ 37 °C with

shaking)

Immunocomplex separation through magnetic particles (second

incubation @ 37 °C with shaking)

Washing

Substrate adding (third incubation @ 37 °C with shaking)

Colour development (with shaking)

Magnetic particles separation and colour reading (in flow cells)

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Data Management

Reading : 546 (main) / 492 (over range) nm

Over range OD is converted through an

instrument dependant factor

Conversion factor is determined during QC

procedures for each machine

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Data Management

Wavelength (nm)

Abs

Phenolphtalein absorption spectrum

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Immunoassay Calibration

Master curve is stored into the smart card of each

specific reagents and it is verified by a two points

calibration procedure

Frequency of two point verification: every 2 - 4

weeks (test dependant)

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Immunoassay CalibrationImmunoassay Calibration

CASE#1:CASE#1: C1 & C2 within calculation threshold → the master curve is left as it is

CASE#2:CASE#2: C1 & C2 within the acceptance threshold → the master curve is accepted and adjusted

Checking the Curve

CASE#3CASE#3:: C1 & C2 are outside the acceptance threshold → Invalid curve → troubleshoot and repeat controls OR perform 6 points standardization

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Immunoassay CalibrationImmunoassay Calibration

CALIBRATION. WHEN?

New kit lot (specific or common reagents)

Calibration expired

The quality control sera outside acceptability ranges

It is required by regulatory

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Immunoassay and Clinical ChemistryImmunoassay and Clinical Chemistry

Immunoassay

Validated and closed system

Immediate availability of kits and consumables

Clinical chemistry

Validated and closed system

Immediate availability of kits and consumables

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Clinical Chemistry: Method DescriptionClinical Chemistry: Method Description

Clinical chemistry reactions can be classified in three

main groups:

End-point calculations

Kinetic

Fixed time

The principle on which the photometry is based on is

“If a monochromatic radiation passes through a solution the absorption takes place. The amount of radiation absorbed (ABSORBANCE) is directly proportional to the thickness and to the concentration of the solution”

A = ε b c

ε = wavelength-dependent molar coefficient with units of L mol-1cm-1

b = is the path lengthc = concentration

Lambert and Beer lawLambert and Beer law

The absorption of the solution is called:

ABSORBANCE=OPTICAL DENSITY=EXTINCTION

Measuring at the same λ the absorbance of a solution with known concentration A cal (Calibrator) and that one of a solution with an unknown concentration A* it is that:

Lambert and Beer lawLambert and Beer law

C*= A* x C cal

A cal

Calibration CurveCalibration Curve

0

0,2

0,4

0,6

0,8

1

1,2

1,4

0 5 10 15

Concentrazione [ ]

Ass

orb

anza

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ConsumablesConsumables

Reaction Segments: reaction Cells for running all

the allowed assays. Each pack contains 100

segments.

ECL cleaning kit: each pack contains 2 bottles of

rinse solution and 10 bottles of de-protein-sing

solution

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Hardware descriptionHardware description

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Hardware description

1133

22Reagent area contains:

1. Reagents (clinical chemistry, immunoassay and specific proteins)2. Calibrator set and C1 & C23. Clinical Chemistry Diluent

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Hardware descriptionHardware description

SAMPLING SYSTEM

It is composed by:

2 sampling needles; Syringe; Peristaltic pump; Needle washing well

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Hardware description

Barcode Reader

Barcode reader allows to identify samples, standards, controls,

reagents and diluents

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Hardware descriptionHardware description

Reaction area: 4 reaction segments – 24 wells each Cells 1 to 4 (segment 1) used for service purposesTotal available cells for analysis: 92

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Hardware descriptionHardware description

Washing station: Flow cells aspiration arm (2 needles) Washing arm (4 dispensing + 8 aspirating needles) Stand for stop and substrate needles

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Hardware descriptionHardware description

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Common reagents drawer:1. Stop solution (white bottle)2. Substrate (brown bottle)3. Needles Washing solution (white external bottle)4. IA washing buffer (white internal bottle)

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Software descriptionSoftware description

Easy User Interface

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Software descriptionSoftware description

Work List Management

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Software descriptionSoftware description

Work List

Execution

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Software description

Data Reduction

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Software description

Maintenance

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Software descriptionSoftware description

Reagent Inventory Management

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Immunoassay ReagentsImmunoassay Reagents

EclecticaTM uses dedicated reagents, allowing a simple reagent management of tests on board

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Immunoassay ReagentsImmunoassay Reagents

Specific Reagent

Calibration Set (Calibrators)

Common Reagents

Diluents

Wash Solution

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Immunoassay ReagentsImmunoassay Reagents

Eclectica Smart card

lot number,

expiry date,

test number available and

Master curve & C1/C2 targets

Specific Reagents: a pack containing the Specific Reagents and a smart card. The number of test is different for each method.

Parametric Multi-calibrator: it is used for calibrating Clinical Chemistry assay. A pack contains the calibrators for 25 analytes and a smart card. Each pack contains 4 bottles to be reconstituted.

Specific Calibrators for HDL and LDL.

Common Reagents: a package of Wash Solution.

Diluent: Each Clinical Chemistry pack contains 3 bottles (3x50 ml).

Clinical Chemistry ReagentsClinical Chemistry Reagents

MULTICALIBRATORMULTICALIBRATOR

Lyophilized, store at 2-8°C

Format: 4 vials x 3 ml

Stability after reconstitution: 2 days at 2-8°C; 8 h a RT; 4 weeks at -20°C

Stability exceptions:

Total Bilirubin: 6 h at RT; 1 day at 2-8°C; 2 weeks at -20°C

Direct Bilirubin: 3 h at RT; 8 h at 2-8°C; 2 weeks at -20°C

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Clinical Chemistry ReagentsClinical Chemistry Reagents

Eclectica Smart card

lot number,

expiry date,

test number available,

values of the specific analytes included in multi-calibrator or in the other calibrators/calibration set

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Immunoassay PanelsImmunoassay Panels

Fertility / Pregnancy

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Immunoassay PanelsImmunoassay Panels

Thyroid

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Immunoassay Panels

Tumor Markers

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Immunoassay PanelsImmunoassay Panels

Other Tests

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Immunoassay PanelsImmunoassay Panels

Calibration Sets

Clinical Chemistry Test MenuClinical Chemistry Test Menu

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Immunoassay PanelsImmunoassay Panels

THE FUTURE

Within the next year: New assays

U-PSA

Thyroglobulin

ToRCH

Thymidine Kinase

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Operational/ProductivityOperational/Productivity

Throughput

Immunoassay: up to 48 tests/hour

Clinical Chemistry: up to 102 tests/hour

n° of methods on-board

max 20, for single-reagent methods

n° of samples

60

Sample dilution

Dilution on board

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Operational/ProductivityOperational/Productivity

1st Profile: Thyroid15 test TSH15 test Free T315 test Free T4Total Time = 2h, 13 ‘35 test/h

2nd Profile: Fertility5 test FSH5 test Progesteron5 test Estradiol5 test LH5 test PRLTotal Time = 2h, 18 ‘17 test/h

3rd Profile: Steroids9 test Estradiol9 test Progesterone 7 test TestosteroneTotal Time = 2’ 18’ 09’’ 17 test/h

IMMUNOASSAY THROUGHPUT

CLINICAL CHEMISTRY THROUGHPUT

Work list

20 test Creatinine,

20 test Cholesterol,

20 test AST-GOT,

20 test ALT-GTP,

20 test Glucose

5 DIFFERENT METHODS

TOTAL: 100 test per 2 run

Time for the first result in the first run: 3’ 30’’ (ALT)

Total time from the first result: 1 h 17’ 20’’

Test/hour after first result: 81 test/h

Sequence of results

1) ALT-GPT

2) AST-GOT

3) Creatinine

4) Cholesterol

5) Glucose

Operational/ProductivityOperational/Productivity

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ComplianceCompliance

All ECLECTICATM products (instrument and reagents) are CE marked in compliance with the IVD DIRECTIVE 98/79/EC OF

THE EUROPEAN PARLIAMENT AND OF THE COUNCIL (27/10/1998) on in vitro diagnostic medical devices .

All ECLECTICATM products (instruments and reagents) are

designed and produced in compliance with the requirements of

ISO 9001:2008 and ISO 13485:2003 international standards.

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ComplianceCompliance

Eclectica Instrument/System Quality Control Process

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QC

In

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QC

Sys

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Instrument Assembly

QC Procedure IOQCI01 Check of

Eclectica InstrumentIs the QC passed? QC Procedure

IOQCI01

Form Mod01–IOQCI01 Form Mod02–IOQCI01

No

YesInstrument transfer to

Adaltis’ plant

Yes

QC Procedure IOQCD08

Check of Eclectica System

Is the QC passed?

Technical intervention (OMS, Adaltis)

No

Form Mod01–IOQCD08

Is the QC passed?

Instrument releasedPGQCI01

General Control of Eclectica System

Yes

Installation Service Manual

procedures

Surveillance post Sales

Installation Check List

OMS facilities

Adaltis facilities

On the field

No

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ComplianceCompliance

Eclectica Reagents Production/Quality Control Process

Rea

gent

s U

nit

Acc

onta

ble

Incoming raw materials

QC process Is the QC passed ?

Lot of raw material reject

No

Bulk production and Activity assignment

QC procedure post-filling

Reagents (IOQCD05) Calibrators (CQ069)

Is the QC passed ?

Yes

Reagent filling(Production SOPs)

Yes

Bulk re-working/correction No

QC procedure post-filling

Reagents (IOQCD05) Calibrators (CQ069)

Stabilizing time if necessary

Is the QC passed ?

QC procedure for generation of

Smart-Card Data (IOQCD05)

Yes

No

Production process

(Production SOPs)

Product rejection(if a re-woring is not

possible)

Specific Reagents and Calibrator released

Final kit packaging and final check

IOMD04IOQCD18/IOQCD19

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BenefitsBenefits

FEATURES BENEFITS

Able to perform Immunoassay, Clinical Chemistry and Specific Proteins (the latter to be validated)

One platform consolidation

Compact instrument Small space needed

No hydraulic or wall connections Easy installation

User friendly software Easy training

Touch screen monitor Fast and easy session programming

Bar-coded reagents/samples Positive identification

Refrigerated reagents area Reagent can be left on board

Use of the same sample tube for IA, CC and SP One work list

Sample dilution on board Rapid and accurate test preparation

Liquid level sensor for samples and reagents Analytical accuracy

Smart-Card Rapid and safe automatic reagent data load

Calibration with master curve loaded on board through smart card

Reduced calibration tests