Bench-top system for Immunoassay & Clinical Chemistry

Bench-top system for Immunoassay & Clinical Chemistry Eclectica is a hybrid analyzer addressing the growing need for consolidation of automation platforms in clinical labs. Eclectica. which derives from the Greek word Eklektikos meaning assorted, combines the best of different methods into a compact, single workstation with the ability to perform Immunoassay and Clinical Chemistry tests.. Simplified routine by combining Immunoassay & Clinical Chemistry in a single workstation. 2 Immunoassay & Clinical Chemistry Bench-Top System

. Eclectica is a bench top analyzer consisting of two carousels, one to process samples and the other to process reagents, each with its own barcode reader. Technical Characteristics. Small-in size (85 cm. wide, 66 cm. deep, and 54 cm height).. Eclectica fits easily on any lab bench.. No hydraulic or wall connections are required.. The touch screen, color-integrated monitor, together with the separate, alphanumeric keyboard, provides the user with a friendly and fast interface.. An embedded PC controls all steps from primary tube allocation to the printing results.. Download and upload data through a direct connection between Eclectica and a Laboratory Information System (LIS). With its user-friendly software Open-Lab and immediate graphs, Eclectica, designed for simplicity, checks analytical and technical performance in real time. Eclectica software features: aload work list and perform active updating by touch screen, keyboard, or LIS acreate test profile amonitori analyzer functions in real time Extensive calibration runs performed at Adaltis and other research laboratories validated master curve data which stored on the smart card. Size 85 cm (33 in.) width, 66 cm (26 in.) depth, 54.4 cm (21 in.) height; 60 kg (132,28 lb) weight. Electrical features 115-230 VAC; 50-60 Hertz Environmental Temperature 15-35 C, Humidity 20-80% Reaction area 96 microcuvettes (24x4 disposable units) at controlled temperature incubation (+/- 1,0 C) Sample plate Tube carousel up to 60 positions, with positive sample identification and automatic pre-dilution Tubes sizes 12-13 x 50-100 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 a-magnetic needles for samples and specific reagents. 2 needles common reagents. 8 + 4 (Aspiration + Dispensing) needles for washing step and 2 for readings Dilution module. 1000 ul syringe with 0.3 ul resolution. Zero automatic setting. 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% User Interface. Keyboard - on board. Monitor - Touch Screen. Printer - Internal (external is optional). Barcodes - 2 of 5, 3 of 9, 128, Codabar, UPC/EAN and ISBT-128. Host computer - through communication software 3

ECLECTICA TEST MENU 1. Arm A double arm with two magnetic needles, one for samples and calibrators, the other for specific reagents, to avoid cross contamination. 2 3 2. Smart card reader A smart card reader, located on the front side of the instrument, reads the smart card included in the reagent packaging and loads data related to specific reagents, calibrators, common reagents. 3. Printer An internal, thermal printer is located on the top right side of the device, prints the results. An external printer can also be connected for customized reports. 1 4 5 4 Immunoassay & Clinical Chemistry Bench-Top System

Technical Features - Operational 4. Reagent carousel Reagent position on the analyzer 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. There are 20 positions defined for specific reagents and 28 positions defined for calibrators. Because the reagent carousel is cooled, reagents can remain on board for several days. The analyzer is always ready, saving space in the laboratory refrigerator and simplifying the daily routine 5. Samples carousel The carousel has sixty positions reserved for primary test tubes, ranging in size from 12/13 mm. by 50/100 mm. Test tubes can be loaded directly on board for Immunoassay and Clinical Chemistry tests. Disposable, self-emptying reaction well 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 magnetic, solid phase container. 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. 6. Monitor A 12-inch, flat, touch screen video accepts input from touch or pen. Access Batch mode Throughput. Immunoassay: up to 48 tests/hour. Clinical Chemistry: up to 90 tests/hour Methodologies. Immuonoassay: Magnetic separation (Sandwich and Competitive); Alkaline Phosphatase conjugates. Clinical Chemistry: Kinetic, Fixed Time, End Point Calibration Master Curve on Board for IA, (from 1 to 8 standards), calibrator or standard for Clinical Chemistry.. N of test on-board - max 20, for single-reagent methods. N of test tubes - 60 Sample identification Positive through barcode reader Reagents identification Positive through barcode reader Sample dilution Dilution (on request or automatic) Patient Database Patient personal data record exportable to host computer 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. Directive 98/79/EC. Quality: ISO 9001, ISO13485 6 5

Immunoassay and Clinical Chemistry: Method Principles a General Eclectica employs 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.. Direct Immuno-enzymatic Assay (IEMA). Competitive Immuno-enzymatic Assay (EIA) a Immunoassay: Method Principles The Eclectica reaction scheme for Immunoassay includes reagents for all reaction steps:. Monoclonal/Polyclonal antibodies for immunoreaction.. Separation reagents consisting of magnetic particles linked to an antibody specifically for FITC for magnetic solid phase separation reaction.. Enzyme/Substrate for color development.. All the reagents are ready to use.. Minimum reaction volumes assure rapid testing and reduction of liquid waste. a Direct Immuno-enzymatic Assay (IEMA) In the Immuno-reaction for the direct immunoassay, the sample incubates with two carefully selected antibodies. These antibodies react to the subject analyze by forming a sandwich. The specific reagent is composed of one antibody labeled with an enzyme, alkaline phosphates and another antibody labeled with FITC. Immunoassay & Clinical Chemistry Bench-Top System

www.adaltis.net a Competitive Immuno-enzymatic Assay (EIA) In the immuno-reaction for the competitive EIA, only one alkaline phosphates labeled antibody is used. A FITC conjugate reagent is added that competes with the sample analyte for the limited number of binding sites available on the small amount of added antibody. a Magnetic Particles After the first incubation, magnetic particles («Separation reagent») are added that react with the FITC-labeled antibody to form an immuno-complex. The application of a magnetic field allows for B/F separation. a Colour Development Enzymatic degradation of the substrate by the alkaline phosphatase, through endpoint kinetics, gives an analytical signal. The flexibility of this method makes possible testing of both small (such as Haptens) and large molecules using a universal separation reagent, substrate, stop solution and washing solution. Simultaneous reading at two wavelengths means accurate readings on a wide concentration of ranges. a Clinical Chemistry The Clinical Chemistry assays are according to IFCC recommendation and German standardization (DGKC). There are three main groups of clinical, chemistry reactions:. End-point calculations. Kinetic. Fixed time 7

SOFTWARE CHARACTERISTICS. New user-friendly software and immediate user Interface have been designed for a simplified routine as well as analytical and technical performance checks in real time. 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:. EUI: Easy User Interface (EUI) is modular and simple to configure.. Easy Worklist Programming: Run calibrators and controls together with samples. Simple to use with many queries available.. Compact maintenance module: All of the maintenance steps are contained in one menu. Software prompts you for the correct maintenance procedure 8 Immunoassay & Clinical Chemistry Bench-Top System

In every IA method, a master curve is read directly from the smart card and stored on board. The software uses tcontrols 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 clinical chemistry and immunoassay tests offered by Eclectica. A wide parameter menu as well as our continuous product development program makes Eclectica able to fulfill present and future laboratory needs. The Immunoassay menu includes a broad range of tests for fertility, pregnancy, thyroid, tumor markers, anemia and diabetes. Extensive panels of Clinical Chemistry are provided as well. 9

ECLECTICA TEST MENU CLINICAL CHEMISTRY TEST MENU Code Description Package 1752200 ALP 300 tests 1752100 AST/GOT 300 tests 1752400 ALT/GPT 300 tests 1752300 Amylase 120 tests 1766100 Direct Bilirubin 60 tests 1765900 Total Bilirubin 60 tests 1770200 Calcium 300 tests 1770300 Chloride 100 tests 1766300 Cholesterol 300 tests 1766800 Cholesterol - HDL 90 tests 1767100 Cholesterol-LDL 48 tests 1752600 CK-NAC 150 tests 1752700 CK-MB 150 tests 1766400 Creatinine 300 tests 1752800 γ-gt 300 tests 1766600 Glucose 300 tests 1766900 Iron 150 tests 1753000 LDH 150 tests 1770500 Phosphorous 120 tests 1767200 Total Protein (TP) 300 tests 1767300 Triglycerides 300 tests 1766200 Urea UV 300 tests 1767400 Uric Acid 120 tests Other Reagents 1750102 Eclectica Wash Solution for 1x900mL Clinical Chemistry 1750000 Eclectica Diluent 3x50mL for Clinical Chemistry 1777017 Eclectica Multi-parametric 4x3mL Calibrator kit 1766817 Cholesterol HDL Calibrator 2x3mL 1767117 Cholesterol LDL Calibrator 2x1mL 1750102P4 Systemic Wash Solution 1x1600 ml INSTRUMENT/ACCESSORIES/CONSUMABLES Code Description Package Accessories for Eclectica ECLP4050000008 Waste bottle 1 ECLP4050000020 Distilled water bottle 1 ECLS4050000028 Adapter for Test-Tubes code LT55476 65 units Consumables for Eclectica ECLP4050000007 Reaction Segments 100 1700006 ECL cleaning kit 10x20mL+ 2x100 ml ECLP2030000002 Thermal paper for 1 internal printer LT55476 Test-Tubes 75x12 mm 500 units 2MP00053 HP DeskJet Printer 1 Phase IV Available by the end of 2011 Immunoassay & Clinical Chemistry Bench-Top System 0

IMMUNOASSAY TEST MENU 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 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 Diabetes 1702800 C-Peptide 2 x 50 tests 1706200 Insulin 2 x 50 tests Anaemia 1709500 Ferritin 2 x 50 tests Tumor Markers 1707600 AFP 2 x 50 tests 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 Metabolism 1703900 Cortisol 2 x 50 tests Code Description Package Calibration Sets 1700117 Androstenedione 5 curves 1707617 AFP 5 curves 1705417 BR-Marker CA 15-3 5 curves 1706617 CEA 5 curves 1703917 Cortisol 5 curves 1702817 C-Peptide 5 curves 1700317 DHEA-S 5 curves 1702617 Estradiol 5 curves 1709517 Ferritin 5 curves 1703517 Free Estriol 5 curves 1706517 Free PSA 5 curves 1708617 Free T3 5 curves 1708517 Free T4 5 curves 1701017 FSH 5 curves 1705317 GI-Marker CA 19-9 5 curves 1703017 HCG 5 curves 1706217 Insulin 5 curves 1702017 LH 5 curves 1705517 OV-Marker CA 125 5 curves 1702717 Progesterone 5 curves 1708017 Prolactin 5 curves 1706417 PSA 5 curves 1705817 SHBG 5 curves 1708417 Total T3 5 curves 1708217 Total T4 5 curves 1706017 Testosterone 5 curves 1707317 TSH 5 curves 1707117 Anti-TPO 5 curves 1707017 Anti-hTG 5 curves Other Reagents 1700010 Common Reagents Kit 200 tests 1700021 Immunoassay 2x1600 ml Wash Solution Kit 1700058 Diluent 1 AFP/PRL/HCG 3x20 ml 1705358 Diluent 2 SHBG/CPT/Ferritin/ 3x20 ml CA 19-9 /CA 15-3/ CA 125/ Anti-TPO/Anti-hTG 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 Phase IV

Adaltis is an international, IVD company headquartered in Rome, Italy. Adaltis develops, manufactures and markets in-vitro diagnostic systems and reagent products to detect viral infections, diagnose immune system diseases and measure human hormone responses. Adaltis manufactures Plab, Nexgen - Automated plates analyzers and Eclectica - Bench top analyzer for IA and CC. Thousands instruments installed all over the globe. With thousands of instruments installed world-wide, Adaltis manufactures for excellence in performance. All of our products are backed by dedicated application support and 24/7 technical service. Our reagents includes the EIAgen - ELISA microplates kits for Infectious diseases, Hepatitis, Serology, ToRCH markers, as well as Retrovirus, Tumor markers and Autoimmunity, Immunoassays, Clinical Chemistries and Controls. Adaltis produces the ALLERGEN- a line of Allergy tests,, and provides a custom line of Antibodies production services. Adaltis ISO 9001 and ISO 13485 certified. All our products are IVD-CE marked. We are dedicated to customer satisfaction and will do the utmost to respond quickly to your needs. Customer Care Center: e-mail: info@adaltis.net Technical Assistance: e-mail: service@adaltis.net Sales and Marketing Office e-mail: sales@adaltis.net Order handling and Logistics e-mail: order@adaltis.net Adaltis S.r.l. Via Luigi Einaudi 7 Guidonia di Montecelio 00012 Rome, Italy Tel: + 39 0774 579333 Fax. + 39 0774 353085 Legal Site Via Durini, 27 20122 Milano, Italy Production and Development Plant Via Luigi Einaudi, 7 Guidonia Montecelio 00012 Rome, Italy Tel: + 39 0774 579333 Fax: + 39 0774 353085 January. 2011 Ref. BRO1006 V1.1 ADALTIS S.r.l. All rights reserved. All trademarks are property of their respective owners. Specifications are subject to change without notice. For more information Contact us directly or visit our new website at: www.adaltis.net www.adaltis.com 12