Adaltis S.r.l. Adaltis S.r.l. YOUR LABORATORY ON A FINGERTIP YOUR LABORATORY ON A FINGERTIP April 2011 April 2011
Mar 29, 2015
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
Fie
ld S
ervi
ce
Eng
inee
r A
ccou
ntab
le
Ada
ltis
QC
In
stru
men
t A
ccou
ntab
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Ada
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QC
Sys
tem
A
ccou
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MS
A
ccou
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le
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