The reliable, compact & versatile immunoassay analyser

Transcription

1 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 immunoassay analyser

2 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. 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. Software Using 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 installation No 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. Fully Automated Immunoassay System

3 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.

4 Technical Specifications Throughput Immunoassay: up to 48 tests/hour Methodologies 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 of test on-board - max 20, for single-reagent methods N of test tubes - 60 Sample and Reagents identification Positive identification via bar code reader Reagents identification Positive reagents identification barcode reader 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 mm 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 Double arm with two non-magnetic needles for samples and specific reagents 2 needles for common reagents (Aspiration + Dispensing) needles for washing step and 2 for readings Dilution module 1000 ul syringe with 0.3 ul resolution Internal and external probe washing Level sensor for the reagents and samples Carry over less than 10 ppm Optical group 6V/10W long life halogen lamp double reading channel 1 group of filters ±2 nm from 340 to 700 nm Self zero setting for all wave lengths. Accuracy ± 1% from 0 to 2.5 O.D. Linearity better than 0.5% Sample dilution Dilution (on request or automatic) Patient Database Patient data record exportable to host computer User Interface Barcodes - 2 of 5, 3 of 9, 128, Codabar, UPC/EAN and ISBT-128 Operator Console Standard PC with Windows XP or higher, PC-monitor (both not included, but are optional) Dedicated Eclectica TiCA operational software Instrumentation Dimensions Size Weight Width 63.8 cm, Depth 63.4 cm, Height 53 cm 60 kg Electrical requirements Voltage Frequency VAC Hz Environmental requirements Temperature C Humidity 20-80% Printout option Multiple Report Format Graphics and print out of results per patient, run and test Software Multitasking operation entire work-list with report operation during execution Compliance CE - IVD - Directive 98/79/EC Quality: ISO 9001, ISO Fully Automated Immunoassay System

5 Automated Immunoassay System

6 Immunoassay Method Principles 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. Immunological Reaction The high surface area of magnetic particles allows for high sensitivity and a wide range of linearity. Direct Immuno-enzymatic Assay (IEMA) Competitive Immuno-enzymatic Assay (EIA) Immunoassay: Method Principles The Eclectica TiCA reaction scheme for immunoassay includes reagents for all reaction steps: Monoclonal/Polyclonal antibodies for immuno-reaction. Separation reagents consisting of magnetic particles linked to an antibody specifically for FITC for magnetic solid phase separation reaction. Enzyme/Substrate for colour development. All the reagents are ready to use. Minimum reaction volumes assure rapid testing and reduction of liquid waste. Fully Automated Immunoassay System

7 Immunoassay Reagents for Eclectica TiCA System Instrument / Accessories / Consumables Code Description Package Fertility/Pregnancy Androstenedione 2 x 50 tests AFP 2 x 50 tests DHEA-S 2 x 50 tests Estradiol 2 x 50 tests Free Estriol 2 x 50 tests FSH 2 x 50 tests HCG 2 x 50 tests LH 2 x 50 tests Progesterone 2 x 50 tests Prolactin 2 x 50 tests SHBG 2 x 50 tests Testosterone 2 x 50 tests Diabetes C-Peptide 2 x 50 tests Insulin 2 x 50 tests Anemia Ferritin 2 x 50 tests Tumour Markers CEA 2 x 50 tests Total PSA 2 x 50 tests Free PSA 2 x 50 tests OV-Marker CA x 50 tests GI-Marker CA x 50 tests BR-Marker CA x 50 tests Code Description Package Thyroid Free T3 2 x 50 tests Free T4 2 x 50 tests Total T3 2 x 50 tests Total T4 2 x 50 tests TSH 2 x 50 tests Anti-TPO 2 x 50 tests Anti-hTG 2 x 50 tests Metabolism Cortisol 2 x 50 tests Other Reagents Common Reagents Kit 200 tests Diluent 1 AFP/PRL/HCG 3x20 ml Diluent 2 SHBG/CPT/Ferritin/ CA 19-9/CA 15-3/CA 125/ Anti-TPO/Anti-hTG 3x20 ml Diluent 3 Estradiol 3x20 ml Diluent 4 Insulin/CEA/PSA 3x20 ml P4 Immunoassay Wash Solution 1x900 ml P4 Systemic Wash Solution 1x1600 ml Code Description Package Eclectica TiCA Instrument ECL01 Eclectica TiCA base unit Accessories for Eclectica TiCA ECLP Waste bottle 1 ECLP Distilled water bottle 1 ECLS Adapter for Test-Tubes 65 units Consumables for Eclectica TiCA ECLP Reaction Segments 100 x ECL cleaning kit 10x20mL + 2x100mL LT55476 Test-Tubes 75x12 mm 500 units System Options for Eclectica TiCA 2MP00053 DeskJet Printer 1 2SL Analyser Operator Console * System Options can be supplied upon request. 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

8 USER FRIENDLY SOFTWARE FOR COMFORTABLE OPERATOR ROUTINE The user-friendly software and user Interface have been designed for a simplified routine for analytical and technical performance checks in real time. 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. Customer Care Center: info@adaltis.net For more information Sales and Marketing Office sales@adaltis.net Technical Assistance: service@adaltis.net Order handling and Logistics order@adaltis.net 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 onboard 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. Legal Registered Office Via Durini, Milano, Italy Tel: Fax Adaltis S.r.l. Headquarter Production and Development Plant Via Luigi Einaudi 7 Guidonia di Montecelio Rome, Italy 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. ADALTIS is certified in compliance with ISO9001 and ISO Our products are CE-IVD.