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

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Presentation on theme: "Adaltis S.r.l. YOUR LABORATORY ON A FINGERTIP April 2011 April 2011."— Presentation transcript:

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

2 1 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.

3 2 Instrument Description Eclectica TM is: very small-sized: 82 cm wide, 66 cm deep, 54 cm high highly compact: all in 0.54 m 2 no hydraulic or wall connections are required Eclectica TM is suitable for laboratories of different dimensions and can be easily placed on every lab bench

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

5 4 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)

6 5 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)

7 6 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

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

9 8 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)

10 9 Immunoassay 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#3: CASE#3: C1 & C2 are outside the acceptance threshold Invalid curve troubleshoot and repeat controls OR perform 6 points standardization

11 10 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

12 11 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

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

14 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 -1 cm -1 b = is the path length c = concentration Lambert and Beer law

15 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 law C*=A* x C cal A cal

16 Calibration Curve

17 16 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

18 17 Hardware description

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

20 19 Hardware description SAMPLING SYSTEM It is composed by: 2 sampling needles; Syringe; Peristaltic pump; Needle washing well

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

22 21 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

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

24 23 Hardware description 3 4 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)

25 24 Software description Easy User Interface

26 25 Software description Work List Management

27 26 Software description Work List Execution

28 27 Software description Data Reduction

29 28 Software description Maintenance

30 29 Software description Reagent Inventory Management

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

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

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

34 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 Reagents

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 35 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

37 36 Immunoassay Panels Fertility / Pregnancy

38 37 Immunoassay Panels Thyroid

39 38 Immunoassay Panels Tumor Markers

40 39 Immunoassay Panels Other Tests

41 40 Immunoassay Panels Calibration Sets

42 Clinical Chemistry Test Menu

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

44 43 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

45 44 Operational/Productivity 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 IMMUNOASSAY THROUGHPUT

46 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/Productivity

47 46 Compliance All ECLECTICA TM 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 ECLECTICA TM products (instruments and reagents) are designed and produced in compliance with the requirements of ISO 9001:2008 and ISO 13485:2003 international standards.

48 47 Compliance

49 48 Compliance

50 49 Benefits FEATURESBENEFITS Able to perform Immunoassay, Clinical Chemistry and Specific Proteins (the latter to be validated) One platform consolidation Compact instrumentSmall space needed No hydraulic or wall connectionsEasy installation User friendly softwareEasy training Touch screen monitorFast and easy session programming Bar-coded reagents/samplesPositive identification Refrigerated reagents areaReagent can be left on board Use of the same sample tube for IA, CC and SPOne work list Sample dilution on boardRapid and accurate test preparation Liquid level sensor for samples and reagentsAnalytical accuracy Smart-CardRapid and safe automatic reagent data load Calibration with master curve loaded on board through smart card Reduced calibration tests

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