DRI ETHYL ALCOHOL ASSAY APPLICATION Beckman Coulter AU400, AU480, AU640, AU680, AU2700, AU5400, AU5800

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1 DRI ETHYL ALCOHOL ASSAY APPLICATION Beckman Coulter AU400, AU480, AU640, AU680, AU2700, AU5400, AU5800 Catalog No. 0037, 0038 Intended for the quantitative determination of alcohol in human urine, serum or plasma For In Vitro Diagnostic Use Only Microgenics Corporation Part of Thermo Fisher Scientific Intended Use The information provided in this application sheet is intended as a supplement to the package insert. Refer to the package insert for information on intended use, reagent storage, reagent preparation, specimen collection, specimen preparation, specimen storage, quality control, and additional performance data. Ordering Information Materials available from Microgenics, a part of Thermo Fisher Scientific Item Size Thermo Fisher Scientific Catalog No. DRI Ethyl Alcohol Assay 1 x 100 ml 1 x 500 ml DRI Negative Alcohol Calibrator DRI Ethyl Alcohol Assay 100 mg/dl Calibrator DRI Ethyl Alcohol Assay 50 mg/dl Alcohol Control DRI Ethyl Alcohol Assay 300 mg/dl Alcohol Control To place an order or for technical service contact: USA Tel: (800) Fax: x 5 ml 1 x 25 ml 1 x 5 ml 1 x 25 ml In Europe x 5 ml x 5 ml 0243 Tel: +49 (0) Fax: +49 (0) Microgenics Corporation, part of Thermo Fisher Scientific Kato Rd, Fremont, CA USA U.S. Toll free: (800) / Tel: (510) U.S. Toll free fax: (888) / Fax: (510) EC REP Microgenics GmbH, Spitalhofstrasse 94, Passau Germany Tel: +49 (0) / Fax: +49(0) Continued on next page Clinical Diagnostics Kato Rd Fremont, CA USA

2 Reagent Storage Refer to the package insert for information on reagent storage. Analyzer Procedure Refer to the operator s manual for information on analyzer operation. Dispense adequate amounts of Buffer Reagent A (first reagent) and Enzyme Reagent E (second reagent) into appropriate containers. Make sure that the reagents have equilibrated to the temperature of the analyzer reagent compartment before starting analysis. Note: Under /General Tab, Linearity % should be left blank, as reflected in the following pages. Do Not Enter 0. Results and Data Interpretation Results for the samples will be printed in mg/dl. Page 2 of APPS, Rev 4

3 DRI Ethyl Alcohol Assay Beckman Coulter System Parameters, AU400/AU640/AU2700/AU5400 General LIH ISE Range Test Name: # < > Type: Urine Operation: Yes Sample: Volume 9.0 µl Dilution 0 µl Pre-Dilution Rate: 1 Reagents: R1 Volume 75 µl Dilution 0 µl Min OD Max OD R2 Volume 75 µl Dilution 0 µl L H 2.50 Reagent OD limit: Wavelength: Pri. 340 Sec. 410 First L First H 2.50 Method: RATE1* Last L Last H 2.50 Reaction slope: + Dynamic Range: Measuring Point 1: First 13 Last 17 L 10 H 600 Measuring Point 2: First Last Correlation Factor: Linearity: % A 1 B 0 No Lag Time: No On-board stability period: # General LIH ISE Range Test Name: # < > Type: Urine Value/Flag: # Level L: # Level H: # Normal Ranges: Age L Age H Sex Year Month Year Month L H 1. # # # # # # # 2. # # # # # # # 3. # # # # # # # 4. # # # # # # # 5. # # # # # # # 6. # # # # # # # 7. None Selected Out of Range L H # # Panic Value: # # Unit: mg/dl Decimal places: # Calibration Specific General ISE Test Name: # < > Type Urine Calibration Type: AA Formula: Y=AX+B Counts: 2 Process: CONC Cal. No. OD CONC Factor/OD-L Factor/OD-H Point 1: # Point 2: # Point 3: Point 4: Point 5: Point 6: Point 7: 1-Point Cal. Point: With CONC-0 MB Type Factor: Calibration Stability Period: # # User Defined * Can be run as FIXED1 Type: Can be programmed in as serum For conversion to g/l change the calibrator concentration to 1 and the units to g/l Page 3 of APPS, Rev 4

4 DRI Ethyl Alcohol Beckman Coulter System Parameters, AU480/AU680 General LIH ISE Range Test Name: # Type: Urine Operation: Yes Sample Volume 9.0 µl Dilution 0 µl OD Limit Pre-Dilution Rate 1 Min. OD Max.OD 3.00 Reagents Volume R1 (R1-1) 75 µl Dilution 0 µl Reagent OD limit: First Low High 3.00 Last Low High 3.00 R2 Volume 75 µl Dilution 0 µl Dynamic Range Low 10 High 600 Common Reagent Type None Name Correlation Factor A 1 B 0 Wavelength: Pri. 340 Sec. 410 Factor for Maker A 1 B 0 Method: FIXED1* Reaction slope: + Onboard Stability 35 Days 0 Hour Measuring Point 1: First 13 Last 17 Measuring Point 2: First Last Linearity: % Lag Time Check: No General LIH ISE Range Test Name: # Type: Urine Value/Flag: VALUE Level L: # Level H: # Specific Ranges: From To Panic Value Sex Year Month Year Month Low High 1. # # # # # # # Low High 2. # # # # # # # # # 3. # # # # # # # 4. # # # # # # # 5. # # # # # # # 6. # # # # # # # 7. No demographics # # 8. Not within expected values # # Calibration Specific General ISE Unit % Decimal Places # Test Name: ETOH Type: Urine Use Serum Cal. Calibration Type: AA Formula: Y=AX+B Counts: 2 <Calibrator Parameters> Slope Check + Factor Range Calibrator OD Conc Low High Point 1: # Point 2: # Point 3: Point 4: Point 5: Point 6: Point 7: Point 8: Point 9: Point 10: <Point Cal for Master Curve> No. of Correction Points Use Master Curve Lot Calibration Calibrator OD Conc OD Range Stability Low High Reagent Blanks # Day # Hour Point 1: Calibration 30 Day 0 Hour Point 2: MB Type Factor: 1-Point Calibration Point With CONC-0 * Can be run as RATE1 # User Defined Values Type: Can be programmed in as serum Page 4 of APPS, Rev 4

5 DRI Ethyl Alcohol Assay Beckman Coulter System Parameters, AU5800 Parameters General LIH ISE HbA1c Calculated Tests Range Test Name: ETOH < > Type: Urine Operation: Yes Sample Volume Volume 9.0 µl Dilution 0 µl OD Limit Pre-Dilution Rate 1 Min OD Max OD 3.00 Reagent Volume R1(R1-1) 75 µl Dilution 0 µl Reagent OD Limit R1-2 µl Dilution µl First Low High 3.00 R2(R2-1) 75 µl Dilution 0 µl Last Low High 3.00 Common Reagent Type None Name Wavelength: Pri. 340 nm Sec. 410 nm Method: FIXED1* Reaction slope: + Dynamic Range Low 10 High 600 Measuring Point 1 First 13 Last 17 Correlation Factor A 1 B 0 Measuring Point 2 First Last Factor for Maker A 1 B 0 Linearity: % Lag Time Check No On-board Stability Period 35 Day 0 Hour Parameters General LIH ISE HbA1c Calculated Tests Range Test Name: ETOH < > Type: Urine Value/Flag: # Level Low High # # Specific Ranges: From To Sex Year Month Year Month Low High 1. # # # # # # # 2. # # # # # # # 3. # # # # # # # 4. # # # # # # # 5. # # # # # # # 6. # # # # # # # 7. Standard Demographics 8. Not within expected values Panic Value Low # High # Unit mg/dl Decimal Places # *Can be run as RATE1 # User Defined Values Type: Can be programmed in as serum Page 5 of APPS, Rev 4

6 DRI Ethyl Alcohol Assay Beckman Coulter System Parameters, AU5800 (Continued) Parameters Calibration Parameters Calibrators Calibration Specific STAT Table Calibration Test Name ETOH < > Type Urine Use Serum Cal. Calibration Type AA Formula Y=AX+B Counts 2 < Calibrator Parameters> Factor Range Slope Check + Calibrator OD Conc Low High Point-1 # Allowable Range Check Point-2 # Reagent Blank Point-3 Calibration Point-4 Point-5 Advanced Calibration Point-6 Operation No Point-7 Interval (RB/ACAL) Point-8 Point-9 Lot Calibration Point-10 < Point Cal. For Master Curve > No. of Correction Points Use Master Curve OD Range Calibrator OD Conc Low High Stability Point-1 Reagent Blank # Day # Hour Point-2 Calibration 30 Day 0 Hour MB Type Factor 1-Point Calibration Point with Conc-0 R1 is Antibody/Substrate and R2 is Enzyme Conjugate. # User Defined Values Type: Can be programmed in as serum For conversion to g/l change the calibrator concentration to 1 and the units to g/l Page 6 of APPS, Rev 4

7 Precision Tests for within-run and total precision, evaluated with packaged reagents, controls and calibrators, yielded the following results (N=80/level): Controls Control 1 Cutoff Control 3 AU480 Mean (mg/dl) Within-Run SD (mg/dl) Within-Run CV (%) Total SD (mg/dl) Total CV (%) AU680 Mean (mg/dl) Within-Run SD (mg/dl) Within-Run CV (%) Total SD (mg/dl) Total CV (%) AU5800 Mean (mg/dl) Within-Run SD (mg/dl) Within-Run CV (%) Total SD (mg/dl) Total CV (%) * N=60/level Page 7 of APPS, Rev 4

8 Linearity Eleven levels of diluted calibrators were run against a single calibration curve and the linearity calculated. The Ethyl Alcohol assay recovered between 98.8% and 104.6% on the AU480 The Ethyl Alcohol assay recovered between 96.2% and 101.3% on the AU680. The Ethyl Alcohol assay recovered between 97.7% and 103.0% on the AU5800. Accuracy and Correlation Urine Samples were assayed using the DRI Ethyl Alcohol Assay on the Beckman Coulter AU480, AU680, AU5800 and tested against LCMS A Linear regression analysis yielded the following: AU480 = 0.93 (LCMS) , r =0.995, n= 100 AU680 = (LCMS) , r = 0.992, n= 100 Page 8 of APPS, Rev 4

9 AU5800 = 0.95 (LCMS) , r = 0.999, n= Thermo Fisher Scientific, Inc. All rights reserved. AU Series Systems are the registered trademarks of Beckman Coulter. All other trademarks are the property of Thermo Fisher Scientific and its subsidiaries. End Page 9 of APPS, Rev 4