ALP (IFCC), AU400/AU640 Serum/Plasma Application ALP (IFCC), AU600 Serum/Plasma Application

System Reagent: OSR6004, OSR6104, OSR6204 Reagent ID: 004 System Reagent: OSR6004, OSR6104, OSR6204 Reagent ID: 004
Specific Test Parameters Specific test parameters
General LIH ISE Range
Test No # Test name ALP04  Sample type Ser  Page ½
Test Name: ALP04    Type: Serum  Operation: Yes 
Sample vol. 3 Dil. Vol 0 L Min. OD Max. OD
Sample: Volume 3 L Dilution 0 L Pre-Dilution Rate: 1 Reagent 1 vol 60 Dil. Vol 60 L L 0.0 H 2.5
Reagents: R1 Volume 60 L Dilution 60 L Min OD Max OD Reagent 2 vol 60 Dil. Vol 60 L Reagent OD limit
R2 Volume 60 L Dilution 60 L L 0.0 H 2.5 Fst. L 0.0 Fst. H 1.2
Reagent OD limit: Wave Main 410 Sub 480  Lst. L 0.0 Lst. H 1.2
Wavelength: Pri. 410  Sec. 480  First L 0.0 First H 1.2 Method RATE  Dynamic range
Method: RATE  Last L 0.0 Last H 1.2 Reaction +  L 5* H 1500*
Reaction slope: +  Dynamic Range: Point 1 Fst 13 Lst 19 Correlation factor A 1
Measuring Point 1: First 13 Last 19 L 5* H 1500* Point 2 Fst Lst B 0
Measuring Point 2: First Last Correlation Factor: Sample Pre-dil Rate ¤

SERUM/PLASMA APPLICATION
Linearity : 15 % A 1 B 0
No Lag Time: NO  On-board stability period: 14 Linearity Fst 15 % Sec %
No lag time NO  On-board stability period 14
Select using Space key, or select from list displayed by Guide key
Specific Test Parameters
General LIH ISE Range Test No # Test name ALP04  Sample type Ser  Page 2/2
Test Name: ALP04    Type: Serum  Level L Level H
Value/flag #  # #
Value/Flag: #  Level L: # Level H: # Normal range
Normal Ranges: Age L Age H Sex Age L Age H L H
Sex Year Month Year Month L H 1 #  # Y # M # Y # M # #
 1. #  # # # # # # 2 #  # Y # M # Y # M # #
 2. #  # # # # # # 3 #  # Y # M # Y # M # #
 3. #  # # # # # # 4 #  # Y # M # Y # M # #
 4. #  # # # # # # 5 #  # Y # M # Y # M # #
 5. #  # # # # # # 6 #  # Y # M # Y # M # #
 6. #  # # # # # # 7 Non select # #
7. None Selected # # 8 Out of range # #
8. Out of Range L H # # L H
Panic Value: # # Unit: U/L* Decimal places: # Panic value # #
Select the function using the Function key or the Mouse
Calibration specific
Calibration Specific
General ISE Test No # Test name ALP04 
Test Name: ALP04    Type Serum  Cal type 1 MB  Count #
Formula 1 Y=AX+B  Process Conc 
Calibration Type: MB  Formula: Y=AX+B  Counts: # Process: CONC 
Selection calibrator
Cal No OD Conc Factor/OD-L Factor/OD-H
Cal. No. OD CONC Factor/OD-L Factor/OD-H
Point 1 §  § § 4000* § 6500*
Point 1: § § § 4000* § 6500*
Point 2:
Point 2 
Point 3: Point 3 
Point 4: Point 4 
Point 5: Point 5 
Point 6: Point 6 
Point 7: Point 7 
1-Point Cal. Point:  with CONC-0 Slope Check: None  Advanced Calibration #  1-point cal. Point
MB type factor #
MB Type Factor: # Calibration Stability Period: ‡ ‡
Calibrator stability period
Select the function using the Function key or the Mouse
# User defined
# User defined ¤ Analyser default value
§ For use in the AB mode only, refer to IFU for further instruction
§ For use in the AB mode only, refer to IFU for further instruction
* Values set for working in U/L. To work in SI units (µkat/L) divide by 60
* Values set for working in U/L. To work in SI units (µkat/L) divide by 60
‡ Depends on usage pattern in the Laboratory
‡ Depends on usage pattern in the Laboratory

Enzyme BSOSR6x04.03
2014-04
ALP (IFCC), AU2700/AU5400 Serum/Plasma Application ALP (IFCC), AU680/AU480 Serum/Plasma Application
System Reagent: OSR6004, OSR6104, OSR6204, OSR6604 Reagent ID: 004 System Reagent: OSR6004, OSR6104, OSR6204 Reagent ID: 004
Parameters Specific Test Parameters
Specific Test Parameters General LIH ISE HbA1c Calculated Test Range
General LIH ISE Range
Test Name: ALP04    Type: Serum  Operation Yes 
Test Name: ALP04   Type: Serum  Operation: Yes 

Sample: Volume 1.8 L Dilution 0 L Pre-Dilution Rate: 1 Sample Volume 1.8 L Dilution 0 L OD Limit
Pre-Dilution Rate 1  Min.OD -0.1 Max.OD 2.5
Reagents: R1 Volume 36 L Dilution 36 L Min OD Max OD
Rgt. Volume R1(R1-1) 36 L Dilution 36 L Reagent OD Limit
R2 Volume 36 L Dilution 36 L L -0.1 H 2.5
First Low -0.1 High 1.2
Reagent OD limit: 0.3
Last Low -0.1 High 1.2
Wavelength: Pri. 410  Sec. 480  First L -0.1 First H 1.2
R2(R2-1) 36 L Dilution 36 L
Method: RATE  Last L -0.1 Last H 1.2
Dynamic Range Low 5* High 1500*
Reaction slope: +  Dynamic Range: Common Rgt. Type Noneф Name ф Correlation Factor A 1 B 0
Measuring Point 1: First 16 Last 27 L 5* H 1500* Wavelength Pri 410 nm Sec. 480 nm Factor for Maker A 1 B 0
Measuring Point 2: First Last Correlation Factor: Method RATE 

SERUM/PLASMA
Linearity : 15 % A 1 B 0

SERUM/PLASMA APPLICATION
Reaction Slope +  Onboard Stability Period 14 Day 0 Hour
No Lag Time: NO  On-board stability period: 14 Measuring Point1 First 16 Last 27 LIH Influence Check # 
Measuring Point2 First Last Lipemia +++++ 
Linearity Limit 15 % Icterus ++++ 
Specific Test Parameters Lag Time Check NO  Hemolysis +++++ 
General LIH ISE Range
Parameters Specific Test Parameters
Test Name: ALP04    Type: Serum  General LIH ISE HbA1c Calculated Test Range

Value/Flag: #  Level L: # Level H: # Test Name: ALP04    Type: Serum 

Normal Ranges: Age L Age H
Sex Year Month Year Month L H Value/Flag: #  Low High
 1. #  # # # # # # Level # # Panic Value
Specific Ranges: From To Low High
 2. #  # # # # # #
Sex Year Month Year Month Low High # #
 3. #  # # # # # #
 1. #  # # # # # #
 4. #  # # # # # #  2. #  # # # # # #

APPLICATION
 5. #  # # # # # #  3. #  # # # # # #
 6. #  # # # # # #  4. #  # # # # # #
7. None Selected # #  5. #  # # # # # #
8. Out of Range L H # #  6. #  # # # # # #
Panic Value: # # Unit: U/L* Decimal places: # 7. No demographics # #
8. Not within expected values # #
Unit U/L* Decimal Places #
Parameters Calibration Parameters
Calibration Specific
Calibrators Calibration Specific STAT Table Calibration
General ISE
General ISE
Test Name: ALP04    Type Serum  Test Name: ALP04    Type Serum   Use Serum Cal.
Calibration Type: MB  Formula: Y=AX+B  Counts: # Process: CONC  Calibration Type: MB  Formula: Y=AX+B  Counts: # 
<Calibrator Parameters> Range
Cal. No. OD CONC Factor/OD-L Factor/OD-H Calibrator OD Conc Low High Slope Check None 
Point 1: § § § 4000* § 6500* Point 1: §  § §4000* §6500*
Point 2: Point 2:  Allowance Range Check
Point 3: Point 3: 
Point 4: Point 4:   Reagent Blank
Point 5: Point 5:   Calibration
Point 6: Point 6: 
Point 7: Point 7  Advanced Calibration
1-Point Cal. Point:  with CONC-0 Slope Check: None  Advanced Calibration: #  Point 8  Operation # 
MB Type Factor: # Calibration Stability Period: ‡ Point 9 
Point 10  Interval (RB/ACAL) # 
<Point Cal. For No. of Correction Points  Use Master Curve   Lot Calibration
# User defined Master Curve> OD Range
§ For use in the AB mode only, refer to IFU for further instruction Calibrator OD Conc Low High Stability
* Values set for working in U/L To work in SI units (µkat/L) divide by 60 Point-1  Reagent Blank ‡ Day ‡ Hour
‡ Depends on usage pattern in the Laboratory Point-2  Calibration Day Hour
ф AU680
MB Type Factor: # 1-Point Calibration Point   with Conc-0

Enzyme BSOSR6x04.03
2014-04
ALP (IFCC), AU5800 Serum/Plasma Application
System Reagent: OSR6004, OSR6104, OSR6204, OSR6604 Reagent ID: 004
Parameters Specific Test Parameters
General LIH ISE HbA1c Calculated Test Range

Test Name: ALP04    Type: Serum  Operation Yes 

Sample Volume 1.4 L Dilution 0 L OD Limit

Pre-Dilution Rate 1  Diluent Bottle #  Min.OD -0.1 Max.OD 2.5
Rgt. Volume R1(R1-1) 28 L Dilution 28 L Reagent OD Limit
st
R1-2 L Dilution L 1 . Low -0.1 High 1.2
Last Low -0.1 High 1.2
R2(R2-1) 28 L Dilution 28 L
Dynamic Range Low 5* High 1500*
Common Rgt. Type None Name None Correlation Factor A 1 B 0
Wavelength Pri 410 nm Sec. 480 nm Factor for Maker A 1 B 0
Method RATE 
Reaction Slope +  Onboard Stability Period 7 Day 0 Hour
Measuring Point1 1st 16 Last 27 LIH Influence Check # 
Measuring Point2 1st Last Lipemia +++++ 

SERUM/PLASMA APPLICATION
Linearity Limit 15 % Icterus ++++ 
Lag Time Check NO  Hemolysis +++++ 

Parameters Specific Test Parameters

General LIH ISE HbA1c Calculated Test Range

Test Name: ALP04    Type: Serum 

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 U/L* Decimal Places #
Parameters Calibration Parameters
Calibrators Calibration Specific
General ISE

Test Name: ALP04    Type Serum  Cuvette . 

□ Use Serum Cal.

Calibration Type: MB  Formula: Y=AX+B  Counts: # 

<Calibrator Parameters> Range
Calibrator OD Conc Low High Slope Check 
Point 1: §  § §4000* §6500*
Point 2:  Allowance Range Check
Point 3: 
Point 4:  □ Reagent Blank
Point 5:  □ Calibration
Point 6: 
Point 7:  Advanced Calibration
Point 8:  Operation # 
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 0 Hour # User defined
Point-2  Calibration ‡ Day 0 Hour * Values set for working in U/L. To work in SI units (µkat/L) divide by 60
§ For use in AB mode only, refer to IFU for further instruction
MB Type Factor: # 1-Point Calibration Point  □ with Conc-0 ‡ Depends on usage pattern in the Laboratory

Enzyme BSOSR6x04.03
2014-04
ALP (IFCC), AU400/AU640 Paediatric Application ALP (IFCC), AU600 Paediatric Application
System Reagent: OSR6004, OSR6104, OSR6204 Reagent ID: 004 System Reagent: OSR6004, OSR6104, OSR6204 Reagent ID: 004

Specific Test Parameters Specific test parameters

General LIH ISE Range
Test No # Test name ALP4P  Sample type Ser  Page 1/2
Test Name: ALP4P    Type: Serum  Operation: Yes 
Sample vol. 3 Dil. vol 10 L Min. OD Max. OD
Sample: Volume 3 L Dilution 10 L Pre-Dilution Rate: 1 Reagent 1 vol 60 Dil. vol 60 L L 0.0 H 2.5
Reagents: R1 Volume 60 L Dilution 60 L Min OD Max OD Reagent 2 vol 60 Dil. vol 50 L Reagent OD limit
R2 Volume 60 L Dilution 50 L L 0.0 H 2.5 Fst. L 0.0 Fst. H 1.2
Reagent OD limit: Wave Main 410 Sub 480  Lst. L 0.0 Lst. H 1.2
Wavelength: Pri. 410  Sec. 480  First L 0.0 First H 1.2 Method RATE  Dynamic range
Method: RATE  Last L 0.0 Last H 1.2 Reaction +  L 5* H 1500*
Reaction slope: +  Dynamic Range: Point 1 Fst 13 Lst 19 Correlation factor A 1
Measuring Point 1: First 13 Last 19 L 5* H 1500* Point 2 Fst Lst B 0
Measuring Point 2: First Last Correlation Factor: Sample Pre-dil Rate ¤
Linearity : 15 % A 1 B 0
No Lag Time: NO  On-board stability period: 14 Linearity Fst 15 % Sec %

PAEDIATRIC APPLICATION
No lag time NO  On-board stability period 14
Select using Space key, or select from list displayed by Guide key
Specific Test Parameters
General LIH ISE Range Test No # Test name ALP4P  Sample type Ser  Page 2/2
Test Name: ALP4P    Type: Serum  Level L Level H
Value/flag #  # #
Value/Flag: #  Level L: # Level H: # Normal range
Normal Ranges: Age L Age H Sex Age L Age H L H
Sex Year Month Year Month L H 1 #  # Y # M # Y # M # #
 1. #  # # # # # # 2 #  # Y # M # Y # M # #
 2. #  # # # # # # 3 #  # Y # M # Y # M # #
 3. #  # # # # # # 4 #  # Y # M # Y # M # #
 4. #  # # # # # # 5 #  # Y # M # Y # M # #
 5. #  # # # # # # 6 #  # Y # M # Y # M # #
 6. #  # # # # # # 7 Non select # #
7. None Selected # # 8 Out of range # #
8. Out of Range L H # # L H
Panic Value: # # Unit: U/L* Decimal places: # Panic value # #
Select the function using the Function key or the Mouse
Calibration specific
Calibration Specific
General ISE Test No # Test name ALP4P 
Test Name: ALP4P    Type Serum  Cal type 1 MB  Count #
Formula 1 Y=AX+B  Process Conc 
Calibration Type: MB  Formula: Y=AX+B  Counts: # Process: CONC 
Selection calibrator
Cal No OD Conc Factor/OD-L Factor/OD-H
Cal. No. OD CONC Factor/OD-L Factor/OD-H
Point 1 §  § § 4000* § 6500*
Point 1: § § § 4000* § 6500*
Point 2:
Point 2 
Point 3: Point 3 
Point 4: Point 4 
Point 5: Point 5 
Point 6: Point 6 
Point 7: Point 7 
1-Point Cal. Point:  with CONC-0 Slope Check: None  Advanced Calibration: #  1-point cal. point
MB type factor #
MB Type Factor: # Calibration Stability Period: ‡ ‡
Calibrator stability period
Select the function using the Function key or the Mouse
# User defined
# User defined ¤ Analyser default value
§ For use in the AB mode only, refer to IFU for further instruction
§ For use in the AB mode only, refer to IFU for further instruction
* Values set for working in U/L. To work in SI units (µkat/L) divide by 60
* Values set for working in U/L. To work in SI units (µkat/L) divide by 60
‡ Depends on usage pattern in the Laboratory
‡ Depends on usage pattern in the Laboratory
Enzyme BSOSR6x04.03
2014-04
ALP (IFCC), AU2700/AU5400 Paediatric Application ALP (IFCC), AU680/AU480 Paediatric Application
System Reagent: OSR6004, OSR6104, OSR6204, OSR6604 Reagent ID: 004 System Reagent: OSR6004, OSR6104, OSR6204 Reagent ID: 004
Parameters Specific Test Parameters
General LIH ISE HbA1c Calculated Test Range
Specific Test Parameters
General LIH ISE Range
Test Name: ALP4P    Type: Serum  Operation Yes 

Test Name: ALP4P   Type: Serum  Operation: Yes 

Sample Volume 1.8 L Dilution 10 L OD Limit
Sample: Volume 1.8 L Dilution 10 L Pre-Dilution Rate: 1 Pre-Dilution Rate 1  Min.OD -0.1 Max.OD 2.5
Reagents: R1 Volume 36 L Dilution 36 L Min OD Max OD Rgt. Volume R1(R1-1) 36 L Dilution 36 L Reagent OD Limit
First Low -0.1 High 1.2
R2 Volume 36 L Dilution 26 L L -0.1 H 2.5
Last Low -0.1 High 1.2
Reagent OD limit: 0.3
R2(R2-1) 36 L Dilution 26 L
Wavelength: Pri. 410  Sec. 480  First L -0.1 First H 1.2
Dynamic Range Low 5* High 1500*
Method: RATE  Last L -0.1 Last H 1.2
Common Rgt. Type Noneф Name ф Correlation Factor A 1 B 0
Reaction slope: +  Dynamic Range:
Wavelength Pri 410 nm Sec. 480 nm Factor for Maker A 1 B 0
Measuring Point 1: First 16 Last 27 L 5* H 1500*
Method RATE 
Measuring Point 2: First Last Correlation Factor:
Reaction Slope +  Onboard Stability Period 14 Day 0 Hour
Linearity : 15 % A 1 B 0
Measuring Point1 First 16 Last 27 LIH Influence Check # 
No Lag Time: NO  On-board stability period: 14
Measuring Point2 First Last Lipemia +++++ 

PAEDIATRIC APPLICATION
Linearity Limit 15 % Icterus ++++ 
Lag Time Check NO  Hemolysis +++++ 
Specific Test Parameters
General LIH ISE Range Parameters Specific Test Parameters
General LIH ISE HbA1c Calculated Test Range
Test Name: ALP4P    Type: Serum 
Test Name: ALP4P    Type: Serum 
Value/Flag: #  Level L: # Level H: #
Normal Ranges: Age L Age H Value/Flag: #  Low High
Sex Year Month Year Month L H Level # # Panic Value
 1. #  # # # # # # Specific Ranges: From To Low High
Sex Year Month Year Month Low High # #
 2. #  # # # # # #
 1. #  # # # # # #
 3. #  # # # # # #
 2. #  # # # # # #
 4. #  # # # # # #
 3. #  # # # # # #
 5. #  # # # # # #  4. #  # # # # # #
 6. #  # # # # # #  5. #  # # # # # #
7. None Selected # #  6. #  # # # # # #
8. Out of Range L H # # 7. No demographics # #
Panic Value: # # Unit: U/L* Decimal places: # 8. Not within expected values # #
Unit U/L* Decimal Places #
Parameters Calibration Parameters
Calibration Specific Calibrators Calibration Specific STAT Table Calibration
General ISE
General ISE
Test Name: ALP4P    Type Serum   Use Serum Cal.
Test Name: ALP4P    Type Serum 
Calibration Type: MB  Formula: Y=AX+B  Counts: # 
Calibration Type: MB  Formula: Y=AX+B  Counts: # Process: CONC 
<Calibrator Parameters> Range
Calibrator OD Conc Low High Slope Check None 
Cal. No. OD CONC Factor/OD-L Factor/OD-H
Point 1: §  § §4000* §6500*
Point 1: § § § 4000* § 6500* Point 2:  Allowance Range Check
Point 2: Point 3: 
Point 3: Point 4:   Reagent Blank
Point 4: Point 5:   Calibration
Point 5: Point 6: 
Point 6: Point 7  Advanced Calibration
Point 7: Point 8  Operation # 
1-Point Cal. Point:  with CONC-0 Slope Check: None  Advanced Calibration: #  Point 9 
MB Type Factor: # Calibration Stability Period: ‡ Point 10  Interval (RB/ACAL) # 
<Point Cal. For No. of Correction Points  Use Master Curve   Lot Calibration
Master Curve> OD Range
# User defined Calibrator OD Conc Low High Stability
§ For use in the AB mode only, refer to IFU for further instruction Point-1  Reagent Blank ‡ Day ‡ Hour
* Values set for working in U/L. To work in SI units (µkat/L) divide by 60 Point-2  Calibration Day Hour
‡ Depends on usage pattern in the Laboratory MB Type Factor: # 1-Point Calibration Point   with Conc-0
ф AU680

Enzyme BSOSR6x04.03
2014-04
ALP (IFCC), AU5800 Paediatric Application
System Reagent: OSR6004, OSR6104, OSR6204, OSR6604 Reagent ID: 004
Parameters Specific Test Parameters
General LIH ISE HbA1c Calculated Test Range

Test Name: ALP4P    Type: Serum  Operation Yes 

Sample Volume 1.4 L Dilution 10 L OD Limit

Pre-Dilution Rate 1  Diluent Bottle #  Min.OD -0.1 Max.OD 2.5
Rgt. Volume R1(R1-1) 28 L Dilution 28 L Reagent OD Limit
st
R1-2 L Dilution L 1 . Low -0.1 High 1.2
Last Low -0.1 High 1.2
R2(R2-1) 28 L Dilution 18 L
Dynamic Range Low 5* High 1500*
Common Rgt. Type None Name None Correlation Factor A 1 B 0
Wavelength Pri 410 nm Sec. 480 nm Factor for Maker A 1 B 0
Method RATE 

SERUM/PLASMA
Reaction Slope +  Onboard Stability Period 7 Day 0 Hour
Measuring Point1 1st 16 Last 27 LIH Influence Check # 
Measuring Point2 1st Last Lipemia +++++ 
Linearity Limit 15 % Icterus ++++ 
Lag Time Check NO  Hemolysis +++++ 

PAEDIATRICAPPLICATION
Parameters Specific Test Parameters
General LIH ISE HbA1c Calculated Test Range

Test Name: ALP4P    Type: Serum 

Value/Flag: #  .
Level Low # High #
Specific Ranges: From To
Sex Year Month Year Month Low High
 1. #  # # # # # #
 2. #  # # # # # #
 3. #  # # # # # #

APPLICATION
 4. #  # # # # # #
 5. #  # # # # # #
 6. #  # # # # # #
7. Standard demographics # #
8. Not within expected values # #
Panic Value Low # High # Unit U/L* Decimal Places #
Parameters Calibration Parameters
Calibrators Calibration Specific
General ISE

Test Name: ALP4P    Type Serum  Cuvette . 

□ Use Serum Cal.

Calibration Type: MB  Formula: Y=AX+B  Counts: # 

<Calibrator Parameters> Range
Calibrator OD Conc Low High Slope Check 
Point 1: §  § §4000* §6500*
Point 2:  Allowance Range Check
Point 3: 
Point 4:  □ Reagent Blank
Point 5:  □ Calibration
Point 6: 
Point 7:  Advanced Calibration
Point 8:  Operation # 
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 # User defined
Point-2  Calibration ‡ Day ‡ Hour § For use in the AB mode only, refer to IFU for further instruction
* Values set for working in U/L. To work in SI units (µkat/L) divide by 60
MB Type Factor: # 1-Point Calibration Point  □ with Conc-0
‡ Depends on usage pattern in the Laboratory

Enzyme BSOSR6x04.03
2014-04