DRI ph-detect APPLICATION BECKMAN COULTER AU640, AU680

Transcription

1 Microgenics Corporation Part of Thermo Fisher Scientific DRI ph-detect APPLICATION BECKMAN COULTER AU640, AU680 Catalog No Intended for the determination of urine ph. 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 ph-detect Assay 500 ml DRI ph-detect Calibrator Set 2 x 25 ml each DRI ph-detect ph 3.6 Control 25 ml DRI ph-detect ph 7.0 Control 25 ml DRI ph-detect ph 10.0 Control 25 ml DRI ph-detect ph 11.5 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

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 into appropriate container. 4. Place the filled reagent container on the reagent trays in positions defined by the user. Ensure that reagent has 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 units of ph. Results and Data Interpretation Results for samples will be printed in units of ph. Page 2 of APPS, Rev. 2

3 Beckman Coulter System Parameters, AU640 Test Name: ph Type: Urine Operation: Yes Sample: Volume 13 L Dilution 0 L Pre-Dilution Rate: 1 Reagents: R1 Volume 160 L Dilution 0 L Min OD Max OD R2 Volume 0 L Dilution 0 L L H Reagent OD limit: Wavelength: Pri. 600 Sec. None First L First H 3.00 Method: End1 Last L Last H 3.00 Reaction slope: + Dynamic Range: Measuring Point 1: First 0 Last 13 L # H # Measuring Point 2: First Last Correlation Factor: Linearity: % A 1 B 0 No Lag Time: No On-board stability period: # Test Name: ph 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: ph Decimal places: # Calibration Specific General ISE Test Name: ph 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: Calibration Stability Period: # # User Defined Page 3 of APPS, Rev. 2

4 Beckman Coulter System Parameters, AU680 Test Name: ph Type: Urine Operation: Yes Sample Volume 13 L Dilution 0 L OD Limit Pre-Dilution Rate 1 Min. OD Max. OD Reagents Volume: R1(R1-1) 160 L Dilution 0 L Reagent OD limit: R2 (R2-1) 0 L Dilution 0 L First Low High 3.00 Last Low High 3.00 Dynamic Range Low # High # Correlation Factor A 1 B 0 Wavelength: Pri. 600 nm Sec. None nm Factor for Maker A 1 B 0 Method: END1 Reaction slope: + Onboard Stability # Days 0 Hour Measuring Point 1: First 0 Last 13 LIH Influence Check # Measuring Point 2: First Last Lipemia Linearity: % Icterus No Lag Time: No Hemolysis General ISE Range Test Name: ph Type: Urine Value/Flag: VALUE Level L: # Level H: # Specific Ranges: From To Panic Value Sex Year Month Year Month Low High Low High 1. # # # # # # # # # 2. # # # # # # # 3. # # # # # # # 4. # # # # # # # 5. # # # # # # # 6. # # # # # # # 7. No demographics # # 8. Not within expected values # # Unit ph Decimal Places # Page 4 of APPS, Rev. 2

5 Beckman Coulter System Parameters, AU680, continued Calibration Specific General ISE Test Name: ph 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: # Reagent Blank Point 2: # 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 # User Defined 2017 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 5 of APPS, Rev. 2