Fully Automated Immunoassay System - Adaltisproduct development program makes Eclectica TiCA able to...
Transcript of Fully Automated Immunoassay System - Adaltisproduct development program makes Eclectica TiCA able to...
Fully Automated Immunoassay System
Eclectica TiCA, an immunoassay analyser addressing your needs for a compact and reliable fully automated platform.
Eclectica TiCA is a newly designed state of the of the art, compact immunoassay analyser. The use of the newest parts and a totally redesigned sample/liquid station will give you a fast, versatile and confident system for your daily laboratory routine.
The reliable, compact & versatile immunoassayanalyser
Fully Automated Immunoassay System
Calibration
Extensive calibration runs performed at Adaltis and other research laboratories. Validated master curve data is stored on the included smart card for each assay, and will save you valuable time and costly calibration testing.
SoftwareUsing Open-Lab with the new friendly user interface, enable simplifying the operation immensely. Work list is easily defined, immediate graphs and monitor analyser functions are provided in real time.
Easy installationNo hydraulic or wall connections are required, Eclectica TiCA has no peripheral cooling, or liquid/buffer containers – all is included in the instrument, just connect it to a pc and you can start working.
Eclectica TiCA, a bench top analyser consisting of two
carousels, one to process samples and the other processing
reagents with barcode reader for positive identification.
Fully controllable process via LIS/LIMS systems.
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Automated Immunoassay System
Arm
A double arm with two non-magnetic needles, one for samples and calibrators, the other for specific reagents avoid cross contamination.
Smart card reader
A smart card reader reads the smart card included in the reagent packaging and loads data related to specific reagents, calibrators, common reagents.
Samples carousel
The sample carousel has sixty positions reserved for primary test tubes. They range in size from 12/13 mm by 50/100 mm. Test tubes can be loaded directly on board for immunoassays.
Disposable, self-emptying reaction cuvette segments reduce the risk of contamination and time spent in «ready mode». There are four segments and each segment has 24 positions for an overall total of 96 positions. In the middle of the carousel are diluents for immunoassay tests as well as a container with the magnetic solid phase.
The unit is compact without outside containers. The Substrate, Stop solution, Wash solution and liquid waste tanks are all located on the right side of the unit.
Reagent carousel
Reagent position on the analyser is transmitted by a self-turning, barcode reader. The instrument uses levels and an automatic counter for double verification. The time for work list preparation is short and risk of reagent misclassification is avoided.
Ready-to-use reagent vials can be randomly allocated. Defined are 20 positions for specific reagents and 28 positions for calibrators. Due to the cooled reagent carousel, reagents can remain on board for several days. The analyser is always ready to use, saving space and energy in the laboratory refrigerator and simplifying the daily routine.
Fully Automated Immunoassay System
Technical Specifications
Reaction area
96 microcuvettes (24x4 disposable units) Controlled temperature incubation (±0,25°C )
Sample plate
Tube carousel up to 60 positions, with positive sample identification and automatic pre-dilution
Tubes sizes
12-13mm x 50-100 mm
User Interface
n Barcodes - 2 of 5, 3 of 9, 128, Codabar, UPC/EAN and ISBT-128
Operator Console
n Standard PC with Windows XP or higher, PC-monitor (both not included, but are optional)
n Dedicated Eclectica TiCA operational software
Instrumentation Dimensions
Size Width 63.8 cm, Depth 63.4 cm, Height 53 cm
Weight 60 kg
Electrical requirements
Voltage 115-230 VAC
Frequency 50-60 Hz
Environmental requirements
Temperature 15-35°C
Humidity 20-80%
Throughput
n Immunoassay: up to 48 tests/hour
Methodologies
n Immunoassay: Magnetic separation (Sandwich and Competitive); Alkaline Phosphatase conjugates
Access
Batch mode
Calibration
Master Curve on Board for IA, (from 1 to 8 standards), calibrator.
n N° of test on-board - max 20, for single-reagent methods
n N° of test tubes - 60
Sample and Reagents identification
Positive identification via bar code reader
Reagents identification
Positive reagents identification barcode reader
Printout option
n Multiple Report Format
n Graphics and print out of results per patient, run and test
Software
Multitasking operation entire work-list with report operation during execution
Compliance
n CE - IVD - Directive 98/79/EC
n Quality: ISO 9001, ISO 13485
Sample dilution
Dilution (on request or automatic)
Patient Database
Patient data record exportable to host computer
Reagent plate
Refrigerated; up to 20 specific reagent positions and up to 28 positions for controls and calibrators on board:positive identification of reagents, calibrators and controls.
Arms and needles
n Double arm with two non-magnetic needles for samples and specific reagents
n 2 needles for common reagents
n 8 + 4 (Aspiration + Dispensing) needles for washing step and 2 for readings
Dilution module
n 1000 ul syringe with 0.3 ul resolution
n Internal and external probe washing
n Level sensor for the reagents and samples
n Carry over less than 10 ppm
Optical group
n 6V/10W long life halogen lamp double reading channel
n 1 group of filters ±2 nm from 340 to 700 nm
n Self zero setting for all wave lengths.
n Accuracy ± 1% from 0 to 2.5 O.D.
n Linearity better than 0.5%
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Automated Immunoassay System
Eclectica TiCA executes a simple, proven, immuno-reaction scheme (IEMA - EIA) based on magnetic particle immunoassay. The separation method is versatile and can be applied to many molecule types, from small molecules to larger molecules, using the same separation reagents in different assay.
The high surface area of magnetic particles allows for high sensitivity and a wide range of linearity.
n Direct Immuno-enzymatic Assay (IEMA)
n Competitive Immuno-enzymatic Assay (EIA)
Immunoassay: Method Principles
The Eclectica TiCA reaction scheme for immunoassay includes reagents for all reaction steps:
n Monoclonal/Polyclonal antibodies for immuno-reaction.
n Separation reagents consisting of magnetic particles linked to an antibody specifically for FITC for magnetic solid phase separation reaction.
n Enzyme/Substrate for colour development.
n All the reagents are ready to use.
n Minimum reaction volumes assure rapid testing and reduction of liquid waste.
Immunoassay Method Principles
Immunological Reaction
Fully Automated Immunoassay System
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Code Description Package
Fertility/Pregnancy
1700100 Androstenedione 2 x 50 tests
1707600 AFP 2 x 50 tests
1700300 DHEA-S 2 x 50 tests
1702600 Estradiol 2 x 50 tests
1703500 Free Estriol 2 x 50 tests
1701000 FSH 2 x 50 tests
1703000 HCG 2 x 50 tests
1702000 LH 2 x 50 tests
1702700 Progesterone 2 x 50 tests
1708000 Prolactin 2 x 50 tests
1705800 SHBG 2 x 50 tests
1706000 Testosterone 2 x 50 tests
Diabetes
1702800 C-Peptide 2 x 50 tests
1706200 Insulin 2 x 50 tests
Anemia
1709500 Ferritin 2 x 50 tests
Tumour Markers
1706600 CEA 2 x 50 tests
1706400 Total PSA 2 x 50 tests
1706500 Free PSA 2 x 50 tests
1705500 OV-Marker CA 125 2 x 50 tests
1705300 GI-Marker CA 19-9 2 x 50 tests
1705400 BR-Marker CA15-3 2 x 50 tests
Code Description Package
Thyroid
1708600 Free T3 2 x 50 tests
1708500 Free T4 2 x 50 tests
1708400 Total T3 2 x 50 tests
1708200 Total T4 2 x 50 tests
1707300 TSH 2 x 50 tests
1707100 Anti-TPO 2 x 50 tests
1707000 Anti-hTG 2 x 50 tests
Metabolism
1703900 Cortisol 2 x 50 tests
Other Reagents
1700010 Common Reagents Kit 200 tests
1700058 Diluent 1 AFP/PRL/HCG 3x20 mL
1705358 Diluent 2 SHBG/CPT/Ferritin/CA 19-9/CA 15-3/CA 125/Anti-TPO/Anti-hTG
3x20 mL
1702658 Diluent 3 Estradiol 3x20 mL
1706658 Diluent 4 Insulin/CEA/PSA 3x20 mL
1700001P4 Immunoassay Wash Solution 1x900 mL
1750102P4 Systemic Wash Solution 1x1600 mL
Immunoassay Reagents for Eclectica TiCA System
Code Description Package
Eclectica TiCA Instrument
ECL01 Eclectica TiCA base unit
1
Accessories for Eclectica TiCA
ECLP4050000008 Waste bottle 1
ECLP4050000020 Distilled water bottle 1
ECLS4050000028 Adapter for Test-Tubes 65 units
Consumables for Eclectica TiCA
ECLP4050000007 Reaction Segments 100 x 24
1700006 ECL cleaning kit 10x20mL+ 2x100mL
LT55476 Test-Tubes 75x12 mm 500 units
System Options for Eclectica TiCA
2MP00053 DeskJet Printer 1
2SL000018 Analyser Operator Console
1
The Calibration Sets are not mandatory to use during your daily work routine and have to be used only a.o. if two point verification of the assay does not pass its validation criteria.
We will provide the Calibration Sets with a priority response time, after your firm order.
* System Options can be supplied upon request.
Instrument / Accessories / Consumables
© June 2016 Ref. BRO1006 V3.3
ADALTIS S.r.l. All rights reserved. All trademarks are property of their respective owners. Specifications are subject to change without prior notice.
Sales and Marketing Officee-mail: [email protected]
Order handling and Logisticse-mail: [email protected]
Customer Care Center:e-mail: [email protected]
Technical Assistance:e-mail: [email protected]
Adaltis S.r.l. HeadquarterProduction and Development Plant
Via Luigi Einaudi 7Guidonia di Montecelio00012 Rome, Italy
Tel: + 39 0774 5791
Fax. + 39 0774 353085
Legal Registered OfficeVia Durini, 2720122 Milano, Italy
The user-friendly software and user Interface have been designed for
a simplified routine for analytical and technical performance checks in real time.
USER FRIENDLY SOFTWARE FOR COMFORTABLE OPERATOR ROUTINE
For more information
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Easy Worklist Programming: Easy User Interface (EUI) is modular and simple to configure.
Step by step on the Worklist: The software checks what you need. You can choose the specific reagent lot. Loading a smart card is direct and simple.
New Warehouse module: Simple to use with many queries available.
Compact maintenance module:
All of the maintenance steps are included in one menu. Software guides you to the correct maintenance procedure.
In every immunoassay method, a master curve is read directly from the smart card and stored. The software operates controls to check the test validity.
Positive barcode ID of samples and reagents, master curve calibration, refrigerated on-board reagent carousel, internal and external washing needle all combine to guarantee a complete and reliable system.
Complete diagnostic profiles available through combined integration of immunoassay tests offered by Eclectica TiCA. A wide parameter menu as well as our continuous product development program makes Eclectica TiCA able to fulfill present and future laboratory needs.
The immunoassay menu includes a broad range of tests for fertility, pregnancy, thyroid, tumour markers, anemia and diabetes.
ADALTIS is certified in compliance with ISO9001 and ISO 13485. Our products are CE-IVD.