DRI CREATININE-DETECT APPLICATION BECKMAN COULTER AU640, AU680

Transcription

1 Microgenics Corporation Part of Thermo Fisher Scientific DRI CREATININE-DETECT APPLICATION BECKMAN COULTER AU640, AU680 Catalog No Intended for the quantitative determination of creatinine in human urine for the detection of adulteration by dilution or substitution with non-urine solution. For In Vitro Diagnostic Use Only Intended Use Ordering Information 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. Item Size Catalog No. DRI Creatinine-Detect Assay 500 ml 1797 DRI Creatinine-Detect Calibrator Set 2 x 25 ml ea DRI Creatinine-Detect 1.3 Control 25 ml DRI Creatinine-Detect 7.5 Control 25 ml DRI Creatinine-Detect 23.0 Control 25 ml To place an order or for technical service contact: USA (800) Fax (510) In Europe Tel: +49 (0) Fax: +49 (0) Microgenics Corporation, part of Thermo Fisher Scientific Kato Road, Fremont, CA USA U.S. Toll free: (800) / Tel: (510) U.S. Toll free fax: (888) / Fax: (510) EC REP B R A H M S GmbH, Neuendorfstrasse 25, 16761, Hennigsdorf, Germany Continued on next page APPS, Rev. 1

2 Reagent Storage Refer to the package insert for information on reagent storage. Analyzer Procedure 1. Refer to the operator s manuals for information on analyzer operation. 2. See package insert for specimen preparation. 3. Dispense adequate amounts of Reagent 1 and Reagent 2 into appropriate containers. 4. Place the filled reagent containers on the reagent trays in positions defined by the user. Ensure that reagents have equilibrated to temperature of analyzer reagent compartment before starting analysis. 5. Perform a reagent volume check as instructed in the operator s manual. 6. Select All to calibrate the test. It is not necessary to test the blank rack during calibration. 7. Define a worklist as instructed in the operator s manual. Press START to begin analysis. 8. Results for calibrators will be printed in Optical Density (OD). Results for samples will be printed in mg/dl. Results and Data Interpretation Results for samples will be printed in mg/dl. Page 2 of APPS, Rev. 1

3 DRI Creatinine-Detect Beckman Coulter System Parameters, AU640 Test Name: CREAT Type: Urine Operation: Yes Sample: Volume 2.5 L Dilution 0 L Pre-Dilution Rate: 1 Reagents: R1 Volume 80 L Dilution 0 L Min OD Max OD R2 Volume 80 L Dilution 0 L L H 3.00 Reagent OD limit: Wavelength: Pri. 520 Sec. 600 First L First H 3.00 Method: FIXED1 Last L Last H Reaction slope: + Dynamic Range: Measuring Point 1: First 13 Last 17 L 0.1 H 184 Measuring Point 2: First Last Correlation Factor: Linearity: % A 1 B 0 No Lag Time: No On-board stability period: # Test Name: CREAT Type: Urine Value/Flag: VALUE 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 # # 8. Out of Range L H # # Panic Value: # # Unit: mg/dl Decimal places: # Calibration Specific General ISE Test Name: CREAT 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 Slope Check + Advanced Calibration: MB Type Factor: # User Defined Calibration Stability Period: Page 3 of APPS, Rev. 1

4 DRI Creatinine-Detect Beckman Coulter System Parameters, AU680 Test Name: CREAT Type: Urine Operation: Yes Sample Volume 2.5 L Dilution 0 L OD Limit Pre-Dilution Rate 1 Min. OD Max. OD Reagents Volume: R1(R1-1) L Dilution 0 L Reagent OD limit: First Low High 3.00 Last Low High 3.00 R2 (R2-1) 80 L Dilution 0 L Dynamic Range 0.1 High 184 Correlation Factor Low A 1 B 0 Wavelength: Pri. 520 nm Sec. 600 nm Factor for Maker A 1 B 0 Method: FIXED1 Reaction slope: + Onboard Stability # Days 0 Hour Measuring Point 1: First 13 Last 17 LIH Influence Check # Measuring Point 2: First Last Lipemia Linearity: % Icterus No Lag Time: No Hemolysis General ISE Range Test Name: CREAT Type: Urine Value/Flag VALUE Level L: # Level H: # : Specific Ranges: Panic From To Value Sex Year Mont Year Mont Low High Low High 1. # # h # # h # # # # # 2. # # # # # # # 3. # # # # # # # 4. # # # # # # # 5. # # # # # # # 6. # # # # # # # 7. No demographics # # 8. Not within expected # # values Unit mg/dl Decimal Places # Page 4 of APPS, Rev. 1

5 Beckman Coulter AU680 Parameters DRI Creatinine-Detect, continued Calibration Specific General ISE Test Name: CREAT Type Urine Use Serum Cal. Calibration Type: AA Formula: Y=AX+B Counts: 2 <Calibrator Parameters> Slope Check + Calibrator OD Conc Factor Range Low High Allowable Range Check Point 1: # 2.0 Y Reagent Blank Point 2: # 20.0 = Calibration Point 3: Advanced Calibration Point 4: Operation Point 5: Interval (RB/ACAL) Point 6: Point 7: Point 8: Point 9: Point10: <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 # Day # Hour Point 2: MB Type Factor: 1-Point Calibration Point With CONC-0 Test Name: CREAT Type: Urine Operation: Yes Sample Volume 2.5 L Dilution 0 L OD Limit Pre-Dilution Rate 1 Min. OD Max. OD Reagents Volume: R1(R1-1) L Dilution 0 L Reagent OD limit: First Low High 3.00 Last Low High 3.00 R2 (R2-1) 80 L Dilution 0 L Dynamic Range 0.1 High 184 Correlation Factor Low A 1 B 0 Wavelength: Pri. 520 nm Sec. 600 nm Factor for Maker A 1 B 0 Method: FIXED1 Reaction slope: + Onboard Stability # Days 0 Hour Measuring Point 1: First 13 Last 17 LIH Influence Check # Measuring Point 2: First Last Lipemia Linearity: % Icterus No Lag Time: No Hemolysis General ISE Range Test Name: CREAT Type: Urine Value/Flag VALUE Level L: # Level H: # : Page 5 of APPS, Rev. 1

6 Specific Ranges: Panic From To Sex Year Mont Year Mont Low High Low High 1. # # h # # h # # # # # 2. # # # # # # # 3. # # # # # # # 4. # # # # # # # 5. # # # # # # # 6. # # # # # # # 7. No demographics # # 8. Not within expected # # values Unit mg/dl Decimal Places # Page 6 of APPS, Rev. 1

7 Beckman Coulter AU680 Parameters DRI Creatinine-Detect, continued Calibration Specific General ISE Test Name: CREAT Type Urine Use Serum Cal. Calibration AA Formul Y=AX+B Counts: 2 <Calibrator Slope Check + Calibrator OD Conc Factor Range Low High Allowable Range Point # 2.0 Y Reagent 1: Point # 20.0 = Blank Calibration 2: Point Advanced 3: Point Calibration Operation 4: Point Interval 5: Point (RB/ACAL) 6: Point 7: Point 8: Point 9: Point1 0: <Point Cal. For Master No. of Correction Use Master Lot Calibration Curve> Calibrator OD Points Conc OD Range Curve Stability Low High Reagent Blanks # Da # Hour Point Calibration # y Da # Hour 1: Point y 2: MB Type Factor: 1-Point Calibration Point With CONC Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. AU Series Systems are trademarks of Beckman Coulter. End Page 7 of APPS, Rev. 1