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Adaltis S.r.l. YOUR LABORATORY ON A FINGERTIP April 2011. System 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. 1. Instrument Description.

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

  2. System 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. 1

  3. Instrument Description EclecticaTM is: very small-sized: 82 cm wide, 66 cm deep, 54 cm high highly 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 2

  4. Instrument Description • Thermal printer • (real time results) • Touch screen Waste tank Common Reagents Drawer Protected working area: Reagent carrousel IA controls and Stds carrousel Sample Plate Reaction plate Dispensing & washing devices Reading chamber Smart card reader USB port • Keyboard with trackball 3

  5. Immunoassay: 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) 4

  6. Immunoassay: 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) 5

  7. 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 6

  8. Data Management Abs Wavelength (nm) Phenolphtalein absorption spectrum 7

  9. 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) 8

  10. Immunoassay Calibration Checking the Curve CASE#1:C1 & C2 within calculation threshold → the master curve is left as it is CASE#2:C1 & C2 within the acceptance threshold → the master curve is accepted and adjusted CASE#3:C1 & C2 are outside the acceptance threshold → Invalid curve → troubleshoot and repeat controls OR perform 6 points standardization 9

  11. Immunoassay Calibration CALIBRATION. WHEN? • New kit lot (specific or common reagents) • Calibration expired • The quality control sera outside acceptability ranges • It is required by regulatory 10

  12. Immunoassay 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 11

  13. Clinical Chemistry: Method Description Clinical chemistry reactions can be classified in three main groups: • End-point calculations • Kinetic • Fixed time 12

  14. Lambert and Beer law 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 length c = concentration

  15. Lambert 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:

  16. Calibration Curve

  17. Consumables • 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 16

  18. Hardware description 17

  19. Hardware description 1 3 2 • Reagent area contains: • Reagents (clinical chemistry, immunoassay and specific proteins) • Calibrator set and C1 & C2 • Clinical Chemistry Diluent 18

  20. Hardware description SAMPLINGSYSTEM • It is composed by: • 2 sampling needles; • Syringe; • Peristaltic pump; • Needle washing well 19

  21. Hardware description Barcode Reader Barcode reader allows to identify samples, standards, controls, reagents and diluents 20

  22. Hardware description • Reaction area: • 4 reaction segments – 24 wells each • Cells 1 to 4 (segment 1) used for service purposes • Total available cells for analysis: 92 21

  23. Hardware description • Washing station: • Flow cells aspiration arm (2 needles) • Washing arm (4 dispensing + 8 aspirating needles) • Stand for stop and substrate needles 22

  24. Hardware description 4 3 • Common reagents drawer: • Stop solution (white bottle) • Substrate (brown bottle) • Needles Washing solution (white external bottle) • IA washing buffer (white internal bottle) 23

  25. Software description Easy User Interface 24

  26. Software description Work List Management 25

  27. Software description Work List Execution 26

  28. Software description Data Reduction 27

  29. Software description Maintenance 28

  30. Software description Reagent Inventory Management 29

  31. Immunoassay Reagents EclecticaTM uses dedicated reagents, allowing a simple reagent management of tests on board 30

  32. Immunoassay Reagents • Specific Reagent • Calibration Set (Calibrators) • Common Reagents • Diluents • Wash Solution 31

  33. Immunoassay Reagents Eclectica Smart card • lot number, • expiry date, • test number available and • Master curve & C1/C2 targets 32

  34. Clinical Chemistry Reagents • 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 Calibratorsfor HDL and LDL. • Common Reagents:a package of Wash Solution. • Diluent: Each Clinical Chemistry pack contains 3 bottles (3x50 ml).

  35. MULTICALIBRATOR • 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

  36. Clinical 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 35

  37. Immunoassay Panels Fertility / Pregnancy 36

  38. Immunoassay Panels Thyroid 37

  39. Immunoassay Panels Tumor Markers 38

  40. Immunoassay Panels Other Tests 39

  41. Immunoassay Panels Calibration Sets 40

  42. Clinical Chemistry Test Menu

  43. Immunoassay Panels THE FUTURE Within the next year: New assays • U-PSA • Thyroglobulin • ToRCH • Thymidine Kinase 42

  44. Operational/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 43

  45. Operational/Productivity IMMUNOASSAY THROUGHPUT 1st Profile: Thyroid 15 test TSH 15 test Free T3 15 test Free T4 Total Time = 2h, 13 ‘ 35 test/h 2nd Profile: Fertility 5 test FSH 5 test Progesteron 5 test Estradiol 5 test LH 5 test PRL Total Time = 2h, 18 ‘ 17 test/h 3rd Profile: Steroids 9 test Estradiol 9 test Progesterone 7 test Testosterone Total Time = 2’ 18’ 09’’ 17 test/h 44

  46. CLINICAL CHEMISTRY THROUGHPUT Operational/Productivity Sequence of results 1)ALT-GPT 2) AST-GOT 3) Creatinine 4) Cholesterol 5) Glucose 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

  47. Compliance 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. 46

  48. Compliance 47

  49. Compliance 48

  50. Benefits 49

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