beckman coulter system reagent, au400/ au400 dri oxycodone … bas100248sq.05 09/13 beckman coulter...

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BAS100248SQ.05 09/13 Beckman Coulter System Reagent, AU400/ AU400 e DRI ® Oxycodone Assay, Semi-Quantitative Cat. No.: Microgenics 100248,100249 Reagent ID: Specific Test Parameters General LIH ISE Range Test Name: OXY Type: URINE Operation: Yes Sample: Volume 10.5 L Dilution 0 L Pre-Dilution Rate: 1 Reagents: R1 Volume 87 L Dilution 0 L Min OD Max OD R2 Volume 87 L Dilution 0 L L 0.00 H 2.50 Reagent OD limit: Wavelength: Pri. 340 Sec. 410 First L 0.00 First H 2.50 Method: RATE1* Last L 0.00 Last H 2.50 Reaction slope: + Dynamic Range: Measuring Point 1: First 17 Last 21 L -99999 H 1000 Measuring Point 2: First Last Correlation Factor: Linearity: 100 % A 1 B 0 No Lag Time: NO On-board stability period: 30 Specific Test Parameters General LIH ISE Range Test Name: OXY Type: URINE Value/Flag: VALUE Level L: -99999 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: # Calibration Specific General ISE Test Name: OXY Type URINE Calibration Type: 5AB Formula: POLYGONAL Counts: 2 Process: CONC Cal. No. OD CONCFactor/OD-L Factor/OD-H Point 1: # 0 -2.00 2.500 Point 2: # 100 -2.00 2.500 Point 3: # 300 -2.00 2.500 Point 4: # 500 -2.00 2.500 Point 5: # 1000 -2.00 2.500 Point 6: Point 7: 1-Point Cal. Point: With CONC-0 Slope Check None Advanced Calibration: ## MB Type Factor: Calibration Stability Period: 14 # User Defined ## Lot or Lot + Bottle DRI ® Calibrators (Cat. No.: 1644 NegCal; Cat. No.: 100250-100Cal; Cat. No.: 100251-300Cal; Cat. No.: 100252-500Cal; and Cat. No.: 100253-1000Cal.) * Can also be run as FIXED1

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Page 1: Beckman Coulter System Reagent, AU400/ AU400 DRI Oxycodone … BAS100248SQ.05 09/13 Beckman Coulter System Reagent, AU600 DRI® Oxycodone Assay, Semi-Quantitative Cat. No.: Microgenics

BAS100248SQ.05 09/13

Beckman Coulter System Reagent, AU400/ AU400e

DRI® Oxycodone Assay, Semi-Quantitative

Cat. No.: Microgenics 100248,100249 Reagent ID:

Specific Test Parameters

General LIH ISE Range

Test Name: OXY Type: URINE Operation: Yes

Sample: Volume 10.5 L Dilution 0 L Pre-Dilution Rate: 1

Reagents: R1 Volume 87 L Dilution 0 L Min OD Max OD

R2 Volume 87 L Dilution 0 L L 0.00 H 2.50

Reagent OD limit:

Wavelength: Pri. 340 Sec. 410 First L 0.00 First H 2.50

Method: RATE1* Last L 0.00 Last H 2.50

Reaction slope: + Dynamic Range:

Measuring Point 1: First 17 Last 21 L -99999 H 1000

Measuring Point 2: First Last Correlation Factor:

Linearity: 100 % A 1 B 0

No Lag Time: NO On-board stability period: 30

Specific Test Parameters

General LIH ISE Range

Test Name: OXY Type: URINE

Value/Flag: VALUE Level L: -99999 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: #

Calibration Specific

General ISE

Test Name: OXY Type URINE

Calibration Type: 5AB Formula: POLYGONAL Counts: 2 Process: CONC

Cal. No. OD CONC† Factor/OD-L Factor/OD-H

Point 1: # 0 -2.00 2.500

Point 2: # 100 -2.00 2.500

Point 3: # 300 -2.00 2.500

Point 4: # 500 -2.00 2.500

Point 5: # 1000 -2.00 2.500

Point 6:

Point 7:

1-Point Cal. Point: With CONC-0 Slope Check None Advanced Calibration: ##

MB Type Factor: Calibration Stability Period: 14

# User Defined ## Lot or Lot + Bottle † DRI

® Calibrators (Cat. No.: 1644 – NegCal; Cat. No.: 100250-100Cal; Cat. No.: 100251-300Cal;

Cat. No.: 100252-500Cal; and Cat. No.: 100253-1000Cal.) * Can also be run as FIXED1

Page 2: Beckman Coulter System Reagent, AU400/ AU400 DRI Oxycodone … BAS100248SQ.05 09/13 Beckman Coulter System Reagent, AU600 DRI® Oxycodone Assay, Semi-Quantitative Cat. No.: Microgenics

BAS100248SQ.05 09/13

Beckman Coulter System Reagent, AU640/AU640e

DRI® Oxycodone Assay, Semi-Quantitative

Cat. No.: Microgenics 100248,100249

Reagent ID:

Specific Test Parameters

General LIH ISE Range

Test Name: OXY Type: URINE Operation: Yes

Sample: Volume 10.5 L Dilution 0 L Pre-Dilution Rate: 1

Reagents: R1 Volume 87 L Dilution 0 L Min OD Max OD

R2 Volume 87 L Dilution 0 L L 0.00 H 2.50

Reagent OD limit:

Wavelength: Pri. 340 Sec. 410 First L 0.00 First H 2.50

Method: RATE1* Last L 0.00 Last H 2.50

Reaction slope: + Dynamic Range:

Measuring Point 1: First 17 Last 21 L -99999 H 1000

Measuring Point 2: First Last Correlation Factor:

Linearity: 100 % A 1 B 0

No Lag Time: NO On-board stability period: 30

Specific Test Parameters

General LIH ISE Range

Test Name: OXY Type: URINE

Value/Flag: VALUE Level L: -99999 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: #

Calibration Specific

General ISE

Test Name: OXY Type URINE

Calibration Type: 5AB Formula: POLYGONAL Counts: 2 Process: CONC

Cal. No. OD CONC† Factor/OD-L Factor/OD-H

Point 1: # 0 -2.00 2.500

Point 2: # 100 -2.00 2.500

Point 3: # 300 -2.00 2.500

Point 4: # 500 -2.00 2.500

Point 5: # 1000 -2.00 2.500

Point 6:

Point 7:

1-Point Cal. Point: With CONC-0 Slope Check None Advanced Calibration: ##

MB Type Factor: Calibration Stability Period: 14

# User Defined ## Lot or Lot + Bottle † DRI

® Calibrators (Cat. No.: 1644 – NegCal; Cat. No.: 100250-100Cal; Cat. No.: 100251-300Cal;

Cat. No.: 100252-500Cal; and Cat. No.: 100253-1000Cal.) * Can also be run as FIXED1

Page 3: Beckman Coulter System Reagent, AU400/ AU400 DRI Oxycodone … BAS100248SQ.05 09/13 Beckman Coulter System Reagent, AU600 DRI® Oxycodone Assay, Semi-Quantitative Cat. No.: Microgenics

BAS100248SQ.05 09/13

DRI® OXYCODONE ASSAY, Semi-Quantitative, AU480

Beckman Coulter System Reagent: Microgenics 100248, 100249 Reagent ID: Specific Test Parameters General LIH ISE Range Test Name: OXY Type: URINE Operation: Yes Sample Volume 10.5 L Dilution 0 L OD Limit Pre-Dilution Rate 1 Min. OD 0.00 Max. OD 3.00 Reagents Volume: R1(R1-1) 87 L Dilution 0 L Reagent OD limit: First Low 0.00 High 3.00 Last Low 0.00 High 3.00 R2 (R2-1) 87 L Dilution 0 L Dynamic Range Low -99999 High 99999 Correlation Factor A 1 B 0 Wavelength: Pri. 340 nm Sec. 410 nm Factor for Maker A 1 B 0 Method: RATE* Reaction slope: + Onboard Stability 30 Days 0 Hour Measuring Point 1: First 17 Last 21 Measuring Point 2: First Last Linearity: 100 % No Lag Time: NO

Specific Test Parameters

General ISE Range

Test Name: OXY Type: URINE Value/Flag: VALUE Level L: -99999 Level H: # Specific Ranges: Panic Value From To

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 #

Calibration Specific General ISE Test Name: OXY Type URINE Use Serum Cal. Calibration Type: 5AB Formula: POLYGONAL Counts: 2 <Calibrator Parameters> Slope Check None Calibrator † OD Conc † Factor Range Low High Allowable Range Check Point 1: # 0 -2.00 2.50 Reagent Blank

Point 2: # 100 -2.00 2.50 Calibration

Point 3: # 300 -2.00 2.50 Advanced Calibration

Point 4: # 500 -2.00 2.50 Operation NO

Point 5: # 1000 -2.00 2.50 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 14 Day 0 Hour

Point 1: Calibration 14 Day 0 Hour Point 2: MB Type Factor: 1-Point Calibration Point With CONC-0

# User Defined † DRI

® Calibrators (Cat. No. 1644 – NegCal; Cat. No.: 100250-100Cal; Cat. No.: 100251-300Cal;

Cat. No.: 100252-500Cal; and Cat No.: 100253-1000Cal.)) * Can also be run as FIXED

Page 4: Beckman Coulter System Reagent, AU400/ AU400 DRI Oxycodone … BAS100248SQ.05 09/13 Beckman Coulter System Reagent, AU600 DRI® Oxycodone Assay, Semi-Quantitative Cat. No.: Microgenics

BAS100248SQ.05 09/13

DRI® OXYCODONE ASSAY, Semi-Quantitative, AU680

Beckman Coulter System Reagent: Microgenics 100248, 100249 Reagent ID: Specific Test Parameters General LIH ISE Range Test Name: OXY Type: URINE Operation: Yes Sample Volume 10.5 L Dilution 0 L OD Limit Pre-Dilution Rate 1 Min. OD 0.00 Max. OD 3.00 Reagents Volume: R1(R1-1) 87 L Dilution 0 L Reagent OD limit: First Low 0.00 High 3.00 Last Low 0.00 High 3.00 R2 (R2-1) 87 L Dilution 0 L Dynamic Range Low -99999 High 99999 Common Reagent Type None Name Correlation Factor A 1 B 0 Wavelength: Pri. 340 nm Sec. 410 nm Factor for Maker A 1 B 0 Method: RATE* Reaction slope: + Onboard Stability 30 Days 0 Hour Measuring Point 1: First 17 Last 21 Measuring Point 2: First Last Linearity: 100 % No Lag Time: NO

Specific Test Parameters

General ISE Range

Test Name: OXY Type: URINE Value/Flag: VALUE Level L: -99999 Level H: # Specific Ranges: Panic Value From To

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 #

Calibration Specific General ISE Test Name: OXY Type URINE Use Serum Cal. Calibration Type: 5AB Formula: POLYGONAL Counts: 2 <Calibrator Parameters> Slope Check None Calibrator † OD Conc † Factor Range Low High Allowable Range Check Point 1: # 0 -2.00 2.50 Reagent Blank

Point 2: # 100 -2.00 2.50 Calibration

Point 3: # 300 -2.00 2.50 Advanced Calibration

Point 4: # 500 -2.00 2.50 Operation NO

Point 5: # 1000 -2.00 2.50 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 14 Day 0 Hour

Point 1: Calibration 14 Day 0 Hour Point 2: MB Type Factor: 1-Point Calibration Point With CONC-0

# User Defined † DRI

® Calibrators (Cat. No. 1644 – NegCal; Cat. No.: 100250-100Cal; Cat. No.: 100251-300Cal;

Cat. No.: 100252-500Cal; and Cat No.: 100253-1000Cal.) * Can also be run as FIXED

Page 5: Beckman Coulter System Reagent, AU400/ AU400 DRI Oxycodone … BAS100248SQ.05 09/13 Beckman Coulter System Reagent, AU600 DRI® Oxycodone Assay, Semi-Quantitative Cat. No.: Microgenics

BAS100248SQ.05 09/13

Beckman Coulter System Reagent, AU600

DRI® Oxycodone Assay, Semi-Quantitative

Cat. No.: Microgenics 100248, 100249

Reagent ID:

Specific test parameters

Test No # Test name OXY Sample type URINE Page 1/2

Sample vol. 10.5 Dil. vol 0 l Min. OD Max. OD

Reagent 1 vol 87 Dil. vol 0 l L 0.00 H 2.500

Reagent 2 vol 87 Dil. vol 0 l Reagent OD limit

Fst. L 0.00 Fst. H 2.500

Wave Main 340 Sub 410 Lst. L 0.00 Lst. H 2.500

Method RATE1* Dynamic range

Reaction + L -99999 H 1000

Point 1 Fst 17 Lst 21 Correlation factor A 1.00

Point 2 Fst Lst B 0.00

Linearity Fst 100 % Sec %

No lag time NO On-board stability period 30

Select using Space key, or select from list displayed by Guide key

Test No # Test name OXY Sample type URINE Page 2/2

Level L Level H

Value/flag VALUE # #

Normal range Sex Age L Age H L H

1 # # Y # M # Y # M # #

2 # # Y # M # Y # M # #

3 # # Y # M # Y # M # #

4 # # Y # M # Y # M # #

5 # # Y # M # Y # M # #

6 # # Y # M # Y # M # #

7 Non select # #

8 Out of range # #

L H

Panic value # #

Select the function using the Function key or the Mouse

Calibration specific

Test No # Name OXY

Cal type 13 5AB Count 2

Formula 3 POLYGONAL Process Conc

Selection calibrator Cal No OD Conc † Factor/OD-L Factor/OD-H

Point 1 # 0 -2.00 2.500

Point 2 # 100 -2.00 2.500

Point 3 # 300 -2.00 2.500

Point 4 # 500 -2.00 2.500

Point 5 # 1000 -2.00 2.500

Point 6

Point 7

1-point cal. point

MB type factor

Calibrator stability period 14

Select the function using the Function key or the Mouse

# User Defined † DRI

® Calibrators (Cat. No.: 1644 – NegCal; Cat. No.: 100250-100Cal; Cat. No.: 100251-300Cal;

Cat. No.: 100252-500Cal; and Cat. No.: 100253-1000Cal.) * Can also be run as FIXED1

Page 6: Beckman Coulter System Reagent, AU400/ AU400 DRI Oxycodone … BAS100248SQ.05 09/13 Beckman Coulter System Reagent, AU600 DRI® Oxycodone Assay, Semi-Quantitative Cat. No.: Microgenics

BAS100248SQ.05 09/13

Beckman Coulter System Reagent, AU2700/AU5400

DRI® Oxycodone Assay, Semi-Quantitative

Cat. No.: Microgenics 100248,100249

Reagent ID:

Specific Test Parameters

General LIH ISE Range

Test Name: OXY Type: URINE Operation: Yes

Sample: Volume 10.5 L Dilution 0 L Pre-Dilution Rate: 1

Reagents: R1 Volume 87 L Dilution 0 L Min OD Max OD

R2 Volume 87 L Dilution 0 L L 0.00 H 2.50

Reagent OD limit:

Wavelength: Pri. 340 Sec. 410 First L 0.00 First H 2.50

Method: RATE1* Last L 0.00 Last H 2.50

Reaction slope: + Dynamic Range:

Measuring Point 1: First 17 Last 21 L -99999 H 1000

Measuring Point 2: First Last Correlation Factor:

Linearity: 100 % A 1 B 0

No Lag Time: NO On-board stability period: 30

Specific Test Parameters

General LIH ISE Range

Test Name: OXY Type: URINE

Value/Flag: VALUE Level L: -99999 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: #

Calibration Specific

General ISE

Test Name: OXY Type URINE

Calibration Type: 5AB Formula: POLYGONAL Counts: 2 Process: CONC

Cal. No. OD CONC† Factor/OD-L Factor/OD-H

Point 1: # 0 -2.00 2.500

Point 2: # 100 -2.00 2.500

Point 3: # 300 -2.00 2.500

Point 4: # 500 -2.00 2.500

Point 5: # 1000 -2.00 2.500

Point 6:

Point 7:

1-Point Cal. Point: With CONC-0 Slope Check None Advanced Calibration: ##

MB Type Factor: Calibration Stability Period: 14

# User Defined ## Lot or Lot + Bottle † DRI

® Calibrators (Cat. No.: 1644 – NegCal; Cat. No.: 100250-100Cal; Cat. No.: 100251-300Cal;

Cat. No.: 100252-500Cal; and Cat. No.: 100253-1000Cal.) * Can also be run as FIXED1

Page 7: Beckman Coulter System Reagent, AU400/ AU400 DRI Oxycodone … BAS100248SQ.05 09/13 Beckman Coulter System Reagent, AU600 DRI® Oxycodone Assay, Semi-Quantitative Cat. No.: Microgenics

BAS100248SQ.05 09/13

DRI® OXYCODONE ASSAY, Semi-Quantitative, AU5800

Beckman Coulter System Reagent: Microgenics 100248, 100249 Reagent ID: Parameters Specific Test Parameters

General LIH ISE Calculated Test Range Test Name: OXY Type: Urine Operation: Yes Sample Volume 10.5 L Dilution 0 L OD Limit Pre-Dilution Rate 1 Diluent Bottle # Min. OD 0.00 Max. OD 3.00 Reagents Volume: R1(R1-1) 87 L Dilution 0 L Reagent OD limit: R1-2 L Dilution L First Low 0.00 High 3.00 Last Low 0.00 High 3.00 R2 (R2-1) 87 L Dilution 0 L Dynamic Range Low -99999 High 99999 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: RATE* Reaction slope: + Onboard Stability 30 Day 0 Hour Measuring Point 1: First 17 Last 21 Measuring Point 2: First Last Linearity Limit: 100 % Lag Time Check: NO

Parameters Specific Test Parameters

General LIH ISE Calculated Tests Range

Test Name: OXY Type: Urine Value/Flag: VALUE Level Low -99999 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 #

Parameters Calibration Parameters

Calibrators Calibration Specific General ISE

Test Name: OXY Type Urine Cuvette Use Serum Cal. Calibration Type: 5AB Formula: POLYGONAL Counts: 2 <Calibrator Parameters> Slope Check None Calibrator † OD Conc † Factor Range Low High Point 1: # 0.0 -2.000 2.500

Point 2: # 100.0 -2.000 2.500 Allowable Range Check

Point 3: # 300.0 -2.000 2.500 Reagent Blank

Point 4: # 500.0 -2.000 2.500 Calibration

Point 5: # 1000.0 -2.000 2.500

Point 6: Advanced Calibration

Point 7: Operation No

Point 8: Interval (RB/ACAL)

Point 9:

Point10: Lot Calibration

<Point Cal. For Master Curve> No. of Correction Points Use Master Curve

Calibrator OD Conc OD Range Stability

Low High Reagent Blank 14 Day 0 Hour

Point 1: Calibration 14 Day 0 Hour Point 2: MB Type Factor: 1-Point Calibration Point With Conc-0

# User Defined † DRI

® Calibrators (Cat. No. 1644 – NegCal; Cat. No.: 100250-100Cal; Cat. No.: 100251-300Cal;

Cat. No.: 100252-500Cal; and Cat No.: 100253-1000Cal.) * Can also be run as FIXED