DRI METHADONE METABOLITE ASSAY APPLICATION BECKMAN COULTER AU400, AU480, AU640, AU680, AU2700, AU5400, AU5800

Transcription

1 Microgenics Corporation Part of Thermo Fisher Scientific DRI METHADONE METABOLITE ASSAY APPLICATION BECKMAN COULTER AU400, AU480, AU640, AU680, AU2700, AU5400, AU5800 Catalog Nos and Intended for the Qualitative and Semi-quantitative Determination of Methadone Metabolite in Human Urine For In Vitro Diagnostic Use Only 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 Catalog Number DRI Methadone Metabolite Assay Reagents 100 ml 500 ml DRI Negative Urine Calibrator 10 ml 25 ml DRI Methadone Metabolite 150 ng/ml Calibrator 10 ml DRI Methadone Metabolite 300 ng/ml Calibrator 10 ml DRI Methadone Metabolite 1000 ng/ml Calibrator 10 ml DRI Methadone Metabolite 2000 ng/ml Calibrator 10 ml MGC Primary DAU Control Set 3 X 5 ml To place an order or for technical service, contact: USA In Europe Tel: (800) Fax: (510) 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. Procedure for Analyzer Refer to the operator s manuals for information on analyzer operation. Results and Data Interpretation Refer to the package insert for information on results and data interpretation. Page 2 of APPS, Rev 4

3 DRI Methadone Metabolite Qualitative Beckman Coulter System, AU400/AU640/AU2700/AU5400 General LIH ISE Range Test Name: # < > Type: Urine Operation: Yes Sample: Volume 13.0 µl Dilution 0 µl Pre-Dilution Rate: 1 Reagents: R1 Volume 87 µl Dilution 0 µl Min OD Max OD R2 Volume 87 µl Dilution 0 µl L H 2.50 Reagent OD limit: Wavelength: Pri. 340 Sec. 410 First L First H 2.50 Method: RATE* Last L Last H 2.50 Reaction slope: + Dynamic Range: Measuring Point 1: First 11 Last 14 L # H # Measuring Point 2: First Last Correlation Factor: Linearity % A 1 B * 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 # # 8. Out of Range L H # # Panic Value: # # Unit: % Decimal places: # # User defined * Can also be run as FIXED * Option 1: Enter 0.0 Option 2: Enter 0.0 Option 3: Enter -100 Option 1: Enter Option 2: Enter 100 Option 3: Enter 0.0 Option 1: Run a reagent blank (blue rack). Run the cutoff calibrator in a white rack. Compare the sample response to the cutoff calibrator response to determine if the sample is positive or negative. Positive samples will not be flagged. Option 2: Run a reagent blank (blue rack). Calibrate by placing the appropriate cutoff calibrator in the assigned position in the calibration rack (yellow rack). Positive samples will be flagged (P) and will be greater than or equal to 100. Option 3: Run a reagent blank (blue rack). Calibrate by placing the appropriate cutoff calibrator in the assigned position in the calibration rack (yellow rack). Positive samples will be flagged (P) and will be greater than or equal to zero. Page 3 of APPS, Rev 4

4 DRI Methadone Metabolite Qualitative, continued Beckman Coulter System, AU400/AU640/AU2700/AU5400 (Option 1) General ISE Test Name: # < > Type Urine Calibration Type: MB 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 7: 1-Point Cal. Point: With CONC-0 Slope Check Advanced Calibration: MB Type Factor: 1000 Calibration Stability Period: (Option 2 or 3) General ISE Test Name: # < > Type Urine Calibration Type: AB 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 7: 1-Point Cal. Point: With CONC-0 Slope Check Advanced Calibration: MB Type Factor: Calibration Stability Period: # # User defined Page 4 of APPS, Rev 4

5 DRI Methadone Metabolite Semiquantitative Beckman Coulter System, AU400/AU640/AU2700/AU5400 General LIH ISE Range Test Name: # < > Type: Urine Operation: Yes Sample: Volume 13.0 µl Dilution 0 µl Pre-Dilution Rate: 1 Reagents: R1 Volume 87 µl Dilution 0 µl Min OD Max OD R2 Volume 87 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 11 Last 14 L # H # 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 # # 8. Out of Range L H # # Panic Value: # # Unit: ng/ml Decimal places: # General ISE Test Name: # < > Type Urine Calibration Type: 5AB Formula: POLYGONAL 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 7: 1-Point Cal. Point: With CONC-0 Slope Check + Advanced Calibration: MB Type Factor: Calibration Stability Period: # # User defined * Can also be run as FIXED1 Page 5 of APPS, Rev 4

6 DRI Methadone Metabolite Assay Qualitative Beckman Coulter System, AU480 / AU680 General LIH ISE Range Test Name: EDDPQ < > Type: Urine Operation: Yes Sample Volume 13.9 µl Dilution 0 µl OD Limit Pre-Dilution Rate 1 Min. OD Max. OD 3.00 Reagents Volume: R1(R1-1) 87 µl Dilution 0 µl Reagent OD limit: R2 (R2-1) 87 µl Dilution 0 µl First Low High 3.00 Last Low High 3.00 Dynamic Range Low # High # Correlation Factor A 1 B 0 Wavelength: Pri. 340 nm Sec. 410 nm Factor for Maker A 1 B 0 Method: FIXED* Reaction slope: + Onboard Stability Days Hour Measuring Point 1: First 11 Last 14 LIH Influence Check Measuring Point 2: First Last Lipemia Linearity: % Icterus No Lag Time: No Hemolysis General ISE Range Test Name: EDDPQ < > Type: Urine Value/Flag: # 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 Decimal Places # # User defined. * Can also be run as RATE Option 1: Run a reagent blank (blue rack). Run the cutoff calibrator in a white rack. Compare the sample response to the cutoff calibrator response to determine if the sample is positive or negative. Positive samples will not be flagged. Option 2: Run a reagent blank (blue rack). Calibrate by placing the appropriate cutoff calibrator in the assigned position in the calibration rack (yellow rack). Positive samples will be flagged (P) and will be greater than or equal to 100. Option 3: Run a reagent blank (blue rack). Calibrate by placing the appropriate cutoff calibrator in the assigned position in the calibration rack (yellow rack). Positive samples will be flagged (P) and will be greater than or equal to zero. Page 6 of APPS, Rev 4

7 DRI Methadone Metabolite Assay Qualitative Beckman Coulter System, AU480 / AU680, continued (Option 1) General ISE Test Name: # < > Type Urine Use Serum Cal. Calibration Type: MB Formula: Y=AX+B Counts: 2 <Calibrator > 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 No Point 5: Interval (RB/ACAL) 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: Point Calibration Point With CONC-0 (Option 2 or 3) General ISE Test Name: EDDPQ < > Type Urine Use Serum Cal. Calibration Type: 2AB Formula: Polygonal Counts: 2 <Calibrator > 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 No Point 5: Interval (RB/ACAL) 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. Page 7 of APPS, Rev 4

8 DRI Methadone Metabolite Assay Semiquantitative Beckman Coulter System, AU480 /AU680 General LIH ISE Range Test Name: EDDPSQ < > Type: Urine Operation: Yes Sample Volume 13.9 µl Dilution 0 µl OD Limit Pre-Dilution Rate 1 Min. OD Max. OD 3.00 Reagents Volume: R1(R1-1) 87 µl Dilution 0 µl Reagent OD limit: R2 (R2-1) 87 µl Dilution 0 µl First Low Hig 3.00 Last Low Hig 3.00 Dynamic Range Low # Hig # Correlation Factor A 1 B 0 Wavelength: Pri. 340 nm Sec. 410 nm Factor for Maker A 1 B 0 Method: FIXED1 Reaction slope: + Onboard Stability Days Hour Measuring Point 1: First 11 Last 14 LIH Influence Check # Measuring Point 2: First Last Lipemia Linearity: % Icterus No Lag Time: Hemolysis General ISE Range Test Name: EDDPS < > Type: Urine Value/Flag: VALUE Level L: # Level H: # Specific Ranges: # User defined. 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 ng/ml Decimal Places # Page 8 of APPS, Rev 4

9 DRI Methadone Metabolite Assay Semiquantitative Beckman Coulter System, AU480 /AU680, continued General ISE Test Name: EDDPSQ < > Type Urine Use Serum Cal. Calibration Type: 5AB Formula: Polygonal Counts: 2 <Calibrator > 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 No Point 5: # Interval (RB/ACAL) 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: # User Defined MB Type Factor: 1-Point Calibration Point None With CONC-0 Page 9 of APPS, Rev 4

10 DRI Methadone Metabolite Assay Qualitative Beckman Coulter System, AU5800 General LIH ISE HbA1c Calculated Test Range Test Name: EDDPQ < > Type: Urine Operation Yes Sample Volume 13.9 µl Dilution 0 µl OD Limit Pre-Dilution Rate 1 Diluent Bottle Outside Min.OD Max.OD 3.00 Rgt. Volume R1(R1-1) 87 µl Dilution 0 µl Reagent OD Limit R1-2 µl Dilution µl 1 st. Low High 3.00 Last Low High 3.00 R2(R2-1) 87 µl Dilution 0 µl Dynamic Range Low # High # Common Rgt. Type None Name None Correlation Factor A 1 B 0 Wavelength Pri 340 nm Sec. 410 nm Factor for Maker A 1 B 0 Method FIXED* Reaction Slope + Onboard Stability Period Day Hour Measuring Point1 1 st 11 Last 14 LIH Influence Check No Measuring Point2 1 st Last Lipemia + Linearity Limit % Icterus + Lag Time Check No Hemolysis + General LIH ISE HbA1c Calculated Test Range Test Name: EDDQ < > 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 % Decimal Places # # User defined. * Can also be run as RATE Option 1: Run a reagent blank (blue rack). Run the cutoff calibrator in a white rack. Compare the sample response to the cutoff calibrator response to determine if the sample is positive or negative. Positive samples will not be flagged. Option 2: Run a reagent blank (blue rack). Calibrate by placing the appropriate cutoff calibrator in the assigned position in the calibration rack (yellow rack). Positive samples will be flagged (P) and will be greater than or equal to 100. Option 3: Run a reagent blank (blue rack). Calibrate by placing the appropriate cutoff calibrator in the assigned position in the calibration rack (yellow rack). Positive samples will be flagged (P) and will be greater than or equal to zero. Page 10 of APPS, Rev 4

11 DRI Methadone Metabolite Assay Qualitative Beckman Coulter System, AU5800, continued (Option 1) Calibrators General ISE Calibration Test Name: # < > Type Urine Cuvette. Use Serum Cal. Calibration Type: MB Formula: Y=AX+B Counts: 2 <Calibrator > Range Calibrator OD Conc Low High Slope Check Point 1: # Point 2: Allowance Range Check Point 3: Point 4: Reagent Blank Point 5: Calibration Point 7: Advanced Calibration Point 8: Operation No Point 9: Point 10: Interval (RB/ACAL) <Point Cal. For No. of Correction Points Use Master Curve Lot Calibration Master Curve> OD Range Calibrator OD Conc Low High Stability Point-1 Reagent Blank # Day # Hour Point-2 Calibration Day Hour MB Type Factor: Point Calibration Point None with Conc-0 (Option 2 or 3) Calibrators General ISE Calibration Test Name: EDDPQ < > Type Urine Cuvette. Use Serum Cal. Calibration Type: 2AB Formula: Polygonal Counts: 2 <Calibrator > Range Calibrator OD Conc Low High Slope Check + Point 1: # Point 2: # Allowance Range Check Point 3: Point 4: Reagent Blank Point 5: Calibration Point 7: Advanced Calibration Point 8: Operation No Point 9: Point 10: Interval (RB/ACAL) <Point Cal. For No. of Correction Points Use Master Curve Lot Calibration Master Curve> OD Range Calibrator OD Conc Low High Stability Point-1 Reagent Blank Day Hour Point-2 Calibration Day Hour MB Type Factor: 1-Point Calibration Point None with Conc-0 # User defined. Page 11 of APPS, Rev 4

12 DRI Methadone Metabolite Assay Semiquantitative Beckman Coulter System, AU5800 General LIH ISE HbA1c Calculated Test Range Test Name: EDDPSQ < > Type: Urine Operation Yes Sample Volume 13.9 µl Dilution 0 µl OD Limit Pre-Dilution Rate 1 Diluent Bottle Outside Min.OD Max.OD Rgt. Volume R1(R1-1) 87 µl Dilution 0 µl Reagent OD Limit R1-2 µl Dilution µl 1 st. Low High 3.00 Last Low High 3.00 R2(R2-1) 87 µl Dilution 0 µl Dynamic Range Low # High # Common Rgt. Type None Name None Correlation Factor A 1 B 0 Wavelength Pri 340 nm Sec. 410 nm Factor for Maker A 1 B 0 Method FIXED1* Reaction Slope + Onboard Stability Period Day Hour Measuring Point1 1 st 11 Last 14 LIH Influence Check No Measuring Point2 1 st Last Lipemia + Linearity Limit % Icterus + Lag Time Check No Hemolysis + General LIH ISE HbA1c Calculated Test Range Test Name: # < > 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 ng/ml Decimal Places # Calibrators General ISE Calibration Test Name: EDDPSQ < > Type Urine Cuvette. Use Serum Cal. Calibration Type: 5AB Formula: Polygonal Counts: 2 <Calibrator > Range Calibrator OD Conc Low High Slope Check + Point 1: # Point 2: # Allowance Range Check Point 3: # Point 4: # Reagent Blank Point 5: # Calibration Point 7: Advanced Calibration Point 8: Operation No Point 9: Point 10: Interval (RB/ACAL) <Point Cal. For No. of Correction Points Use Master Curve Lot Calibration Master Curve> OD Range Calibrator OD Conc Low High Stability Point-1 Reagent Blank Day Hour Point-2 Calibration Day Hour MB Type Factor: 1-Point Calibration Point None with Conc-0 # User defined. Page 12 of APPS, Rev 4

13 2017 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 13 of APPS, Rev 4