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BSOSR6X0907

This document provides information for testing aspartate aminotransferase (AST) using a serum or plasma sample. It lists the reagents, sample volume, wavelengths, measurement points, calibration type, and normal ranges. The test uses two reagents, measured at 340nm and 660nm primary and secondary wavelengths. Calibration is a multi-point method using a formula of Y=AX+B. Normal ranges are provided for different age groups.

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xuanhungyte
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0% found this document useful (0 votes)
75 views

BSOSR6X0907

This document provides information for testing aspartate aminotransferase (AST) using a serum or plasma sample. It lists the reagents, sample volume, wavelengths, measurement points, calibration type, and normal ranges. The test uses two reagents, measured at 340nm and 660nm primary and secondary wavelengths. Calibration is a multi-point method using a formula of Y=AX+B. Normal ranges are provided for different age groups.

Uploaded by

xuanhungyte
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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AST (IFCC, without Pyridoxal phosphate activation), AU400/AU640

Serum/Plasma Application
System Reagent: OSR6009, OSR6109, OSR6209 Reagent ID: 009

Specific Test Parameters


General LIH ISE Range

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

Sample: Volume 10 L Dilution 0 L Pre-Dilution Rate: 1


Reagents: R1 Volume 50 L Dilution 50 L Min OD Max OD
R2 Volume 50 L Dilution 100 L L 0.60 H 2.5
Reagent OD limit:
Wavelength: Pri. 340  Sec. 660  First L 1.1 First H 2.5
Method: RATE  Last L 1.1 Last H 2.5
Reaction slope: -  Dynamic Range:
Measuring Point 1: First 14 Last 27 L 3* H 1000*
Measuring Point 2: First Last Correlation Factor:

SERUM/PLASMA APPLICATION
Linearity : 15 % A 1 B 0
No Lag Time: YES  On-board stability period: 30

Specific Test Parameters


General LIH ISE Range

Test Name: AST    Type: Serum 

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: U/L* Decimal places: #

Calibration Specific
General ISE

Test Name: AST    Type Serum 

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

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


Point 1: § § §3650* §5470*
Point 2:
Point 3:
Point 4:
Point 5:
Point 6:
Point 7:
1-Point Cal. Point:  With CONC-0 Slope Check: None  Advanced Calibration: # 
MB Type Factor: # Calibration Stability Period:

# User defined
* 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 leaflet for further instruction.
Enzyme BSOSR6x09.07
2018-05
AST (IFCC, without Pyridoxal phosphate activation), AU2700/AU5400 AST (IFCC, without Pyridoxal phosphate activation), AU680/AU480
Serum/Plasma Application
Serum/Plasma Application System Reagent: OSR6009, OSR6109, OSR6209, Reagent ID: 009
System Reagent: OSR6009, OSR6109, OSR6209, OSR6609 Reagent ID: 009 Parameters Specific Test Parameters
General LIH ISE HbA1c Calculated Test Range
Specific Test Parameters
General LIH ISE Range Test Name: AST    Type: Serum  Operation Yes 

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


Sample Volume 5 L Dilution 0 L OD Limit
Sample: Volume 5 L Dilution 0 L Pre-Dilution Rate: 1 Pre-Dilution Rate 1  Min.OD 0.60 Max.OD 2.5
Reagents: R1 Volume 25 L Dilution 25 L Min OD Max OD Rgt. Volume R1(R1-1) 25 L Dilution 25 L Reagent OD Limit
R2 Volume 25 L Dilution 50 L L 0.60 H 2.5 First Low 1.1 High 2.5
Reagent OD limit: Last Low 1.1 High 2.5
Wavelength: Pri. 340  Sec. 660  First L 1.1 First H 2.5 R2(R2-1) 25 L Dilution 50 L
Method: RATE  Last L 1.1 Last H 2.5 Dynamic Range Low 3* High 1000*
Reaction slope: -  Dynamic Range: Common Rgt. Type Noneф Name ф Correlation Factor A 1 B 0
Measuring Point 1: First 14 Last 27 L 3* H 1000* Wavelength Pri 340 nm Sec. 660 nm Factor for Maker A 1 B 0
Measuring Point 2: First Last Correlation Factor: Method RATE 
Linearity : 15 % A 1 B 0 Reaction Slope -  Onboard Stability Period 30 Day 0 Hour

SERUM/PLASMA APPLICATION
No Lag Time: YES  On-board stability period: 30 Measuring Point1 First 14 Last 27 LIH Influence Check # 
Measuring Point2 First Last Lipemia +++++ 
Linearity Limit 15 % Icterus +++++ 
Lag Time Check YES  Hemolysis + 
Specific Test Parameters
General LIH ISE Range Parameters Specific Test Parameters
General LIH ISE HbA1c Calculated Test Range
Test Name: AST    Type: Serum 
Test Name: AST    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
 2. #  # # # # # # Sex Year Month Year Month Low High # #
 3. #  # # # # # #  1. #  # # # # # #
 4. #  # # # # # #  2. #  # # # # # #
 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: AST    Type Serum  Test Name: AST    Type Serum   Use Serum Cal.

Calibration Type: MB  Formula: Y=AX+B  Counts: # Process:  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: § § §3650* §5470* Point 1: §  § §3650* §5470*
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
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
* Values set for working in U/L. To work in SI units (µkat/L) divide by 60 Point-1  Reagent Blank Day Hour
§ For use in AB mode only. Refer to IFU for further instruction Point-2  Calibration Day Hour
ф AU680
MB Type Factor: # 1-Point Calibration Point   with Conc-0

Enzyme BSOSR6x09.07
2018-05
AST (IFCC, without Pyridoxal phosphate activition) AU5800 Serum/Plasma Application
System Reagent: OSR6009, OSR6109, OSR6209, OSR6609 Reagent ID: 009
Parameters Specific Test Parameters
General LIH ISE HbA1c Calculated Test Range

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

Sample Volume 5 L Dilution 0 L OD Limit


Pre-Dilution Rate 1  Diluent Bottle #  Min.OD 0.60 Max.OD 2.5
Rgt. Volume R1(R1-1) 25 L Dilution 25 L Reagent OD Limit
R1-2 L Dilution L 1st. Low 1.1 High 2.5
Last Low 1.1 High 2.5
R2(R2-1) 25 L Dilution 50 L
Dynamic Range Low 3* High 1000*
Common Rgt. Type None Name None Correlation Factor A 1 B 0
Wavelength Pri 340 nm Sec. 660 nm Factor for Maker A 1 B 0
Method RATE 
Reaction Slope -  Onboard Stability Period 30 Day 0 Hour

SERUM/PLASMA APPLICATION
Measuring Point1 1st 14 Last 27 LIH Influence Check # 
Measuring Point2 1st Last Lipemia +++++ 

SERUM/PLASMA APPLICATION
Linearity Limit 15 % Icterus +++++ 
Lag Time Check YES  Hemolysis + 

Parameters Specific Test Parameters


General LIH ISE HbA1c Calculated Test Range

Test Name: AST    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: AST    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: §  § §3650* §5470*
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 * 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 § For use in AB mode only, refer to IFU for further instruction

Enzyme BSOSR6x09.07
2018-05
AST (IFCC, with OE60106 activation), AU400/AU640 Serum/Plasma
Application
System Reagent: OSR6009, OSR6109, OSR6209 Reagent ID: 009

Specific Test Parameters


General LIH ISE Range

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

Sample: Volume 10 L Dilution 0 L Pre-Dilution Rate: 1


Reagents: R1 Volume 50 L Dilution 50 L Min OD Max OD
R2 Volume 50 L Dilution 100 L L 1.0 H 2.5
Reagent OD limit:
Wavelength: Pri. 340  Sec. 660  First L 1.3 First H 2.5
Method: RATE  Last L 1.3 Last H 2.5
Reaction slope: -  Dynamic Range:
Measuring Point 1: First 14 Last 27 L 3* H 1000*
Measuring Point 2: First Last Correlation Factor:
Linearity : 15 % A 1 B 0

SERUM/PLASMA APPLICATION
No Lag Time: YES  On-board stability period: 7

Specific Test Parameters


General LIH ISE Range

Test Name: AST    Type: Serum 

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: U/L* Decimal places: #

Calibration Specific
General ISE

Test Name: AST    Type Serum 

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

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


Point 1: § § §3650* §5470*
Point 2:
Point 3:
Point 4:
Point 5:
Point 6:
Point 7:
1-Point Cal. Point:  with CONC-0 Slope Check: None  Advanced Calibration: # 
MB Type Factor: # Calibration Stability Period:

# User defined
* 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.

Enzyme BSOSR6x09.07
2018-05
AST (IFCC, with OE60106 activation), AU2700/AU5400 Serum/Plasma AST (IFCC, with OE60106 activition) AU5800 Serum/Plasma Application
System Reagent: OSR6009, OSR6109, OSR6209, OSR6609 Reagent ID: 009
Application Parameters Specific Test Parameters
System Reagent: OSR6009, OSR6109, OSR6209, OSR6609 Reagent ID: 009 General LIH ISE HbA1c Calculated Test Range

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


Specific Test Parameters
General LIH ISE Range
Sample Volume 5 L Dilution 0 L OD Limit
Test Name: AST    Type: Serum  Operation: Yes  Pre-Dilution Rate 1  Diluent Bottle #  Min.OD 1.0 Max.OD 2.5
Sample: Volume 5 L Dilution 0 L Pre-Dilution Rate: 1 Rgt. Volume R1(R1-1) 25 L Dilution 25 L Reagent OD Limit
Reagents: R1 Volume 25 L Dilution 25 L Min OD Max OD R1-2 L Dilution L 1st. Low 1.3 High 2.5
Last Low 1.3 High 2.5
R2 Volume 25 L Dilution 50 L L 1.0 H 2.5
R2(R2-1) 25 L Dilution 50 L
Reagent OD limit:
Dynamic Range Low 3* High 1000*
Wavelength: Pri. 340  Sec. 660  First L 1.3 First H 2.5
Common Rgt. Type None Name None Correlation Factor A 1 B 0
Method: RATE  Last L 1.3 Last H 2.5
Wavelength Pri 340 nm Sec. 660 nm Factor for Maker A 1 B 0
Reaction slope: -  Dynamic Range:
Method RATE 
Measuring Point 1: First 14 Last 27 L 3* H 1000* Reaction Slope -  Onboard Stability Period 7 Day 0 Hour
Measuring Point 2: First Last Correlation Factor: Measuring Point1 1st 14 Last 27 LIH Influence Check # 
Linearity : 15 % A 1 B 0

SERUM/PLASMA APPLICATION
Measuring Point2 1st Last Lipemia +++++ 
No Lag Time: YES  On-board stability period: 7 Linearity Limit 15 % Icterus +++++ 
Lag Time Check YES  Hemolysis + 

Specific Test Parameters Parameters Specific Test Parameters


General LIH ISE Range General LIH ISE HbA1c Calculated Test Range

Test Name: AST    Type: Serum  Test Name: AST    Type: Serum 

Value/Flag: #  Level L: # Level H: # Value/Flag: # 


Normal Ranges: Age L Age H Level Low # High #
Sex Year Month Year Month L H Specific Ranges: From To
Sex Year Month Year Month Low High
 1. #  # # # # # #
 1. #  # # # # # #
 2. #  # # # # # #
 2. #  # # # # # #
 3. #  # # # # # #  3. #  # # # # # #
 4. #  # # # # # #  4. #  # # # # # #
 5. #  # # # # # #  5. #  # # # # # #
 6. #  # # # # # #  6. #  # # # # # #
7. None Selected # # 7. Standard demographics # #
8. Out of Range L H # # 8. Not within expected values # #
Panic Value: # # Unit: U/L* Decimal places: # Panic Value Low # High # Unit U/L* Decimal Places #
Parameters Calibration Parameters
Calibrators Calibration Specific
General ISE
Calibration Specific
General ISE Test Name: AST    Type Serum  Cuvette . 
□ Use Serum Cal.
Test Name: AST    Type Serum 
Calibration Type: MB  Formula: Y=AX+B  Counts: # 
Calibration Type: MB  Formula: Y=AX+B  Counts: # Process:  <Calibrator Parameters> Range
Calibrator OD Conc Low High Slope Check 
Cal. No. OD CONC Factor/OD-L Factor/OD-H Point 1: §  § §3650* §5470*
Point 1: § § §3650* §5470* 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: 
Point 10:  Interval (RB/ACAL) # 
MB Type Factor: # Calibration Stability Period:
<Point Cal. For No. of Correction Points  Use Master Curve  □ Lot Calibration
Master Curve> OD Range
Calibrator OD Conc Low High Stability
# User defined 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
§ For use in AB mode only. Refer to IFU for further instruction
MB Type Factor: # 1-Point Calibration Point  □ with Conc-0

Enzyme BSOSR6x09.07
2018-05
AST (IFCC, with OE60106 activation ), AU680/AU480 AST (IFCC, with OSR60180 activation), AU680
Serum/Plasma Application Serum/Plasma Application
System Reagent: OSR6009, OSR6109, OSR6209 Reagent ID: 009 System Reagent: OSR6009, OSR6109, OSR6209 Reagent ID: 009
Parameters Specific Test Parameters Parameters Specific Test Parameters
General LIH ISE HbA1c Calculated Test Range General LIH ISE HbA1c Calculated Test Range

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

Sample Volume 5 L Dilution 0 L OD Limit Sample Volume 5 L Dilution 0 L OD Limit


Pre-Dilution Rate 1  Min.OD 1.0 Max.OD 2.5 Pre-Dilution Rate 1  Min.OD 1.0 Max.OD 2.5
Rgt. Volume R1(R1-1) 25 L Dilution 25 L Reagent OD Limit Rgt. Volume R1(R1-1) 25 L Dilution 10 L Reagent OD Limit
First Low 1.3 High 2.5 R1-2 5 L Dilution 10 L First Low 1.3 High 2.5
Last Low 1.3 High 2.5 Last Low 1.3 High 2.5
R2(R2-1) 25 L Dilution 50 L R2(R2-1) 25 L Dilution 50 L
Dynamic Range Low 3* High 1000* Dynamic Range Low 3* High 1000*
Common Rgt. Type Noneф Name ф Correlation Factor A 1 B 0 Common Rgt. Type R1-2 Name # Correlation Factor A 1 B 0
Wavelength Pri 340 nm Sec. 660 nm Factor for Maker A 1 B 0 Wavelength Pri 340 nm Sec. 660 nm Factor for Maker A 1 B 0
Method RATE  Method RATE 
Reaction Slope -  Onboard Stability Period 7 Day 0 Hour Reaction Slope -  Onboard Stability Period 30 Day 0 Hour
Measuring Point1 First 14 Last 27 LIH Influence Check #  Measuring Point1 First 14 Last 27 LIH Influence Check # 
Measuring Point2 First Last Lipemia +++++  Measuring Point2 First Last Lipemia +++++ 

SERUM/PLASMA APPLICATION
Linearity Limit 15 % Icterus +++++  Linearity Limit 15 % Icterus +++++ 
Lag Time Check YES  Hemolysis +  Lag Time Check YES  Hemolysis + 

Parameters Specific Test Parameters Parameters Specific Test Parameters


General LIH ISE HbA1c Calculated Test Range General LIH ISE HbA1c Calculated Test Range

Test Name: AST    Type: Serum  Test Name: AST    Type: Serum 

Value/Flag: #  Low High Value/Flag: #  Low High


Level # # Panic Value Level # # Panic Value
Specific Ranges: From To Low High Specific Ranges: From To Low High
Sex Year Month Year Month Low High # # Sex Year Month Year Month Low High # #
 1. #  # # # # # #  1. #  # # # # # #
 2. #  # # # # # #  2. #  # # # # # #
 3. #  # # # # # #  3. #  # # # # # #
 4. #  # # # # # #  4. #  # # # # # #
 5. #  # # # # # #  5. #  # # # # # #
 6. #  # # # # # #  6. #  # # # # # #
7. No demographics # # 7. No demographics # #
8. Not within expected values # # 8. Not within expected values # #
Unit U/L* Decimal Places # Unit U/L* Decimal Places #
Parameters Calibration Parameters Parameters Calibration Parameters
Calibrators Calibration Specific STAT Table Calibration Calibrators Calibration Specific STAT Table Calibration
General ISE General ISE

Test Name: AST    Type Serum   Use Serum Cal. Test Name: AST    Type Serum   Use Serum Cal.

Calibration Type: MB  Formula: Y=AX+B  Counts: #  Calibration Type: MB  Formula: Y=AX+B  Counts: # 
<Calibrator Parameters> Range <Calibrator Parameters> Range
Calibrator OD Conc Low High Slope Check None  Calibrator OD Conc Low High Slope Check None 
Point 1: §  § §3650* §5470* Point 1: §  § §3650* §5470*
Point 2:  Allowance Range Check Point 2:  Allowance Range Check
Point 3:  Point 3: 
Point 4:   Reagent Blank Point 4:   Reagent Blank
Point 5:   Calibration Point 5:   Calibration
Point 6:  Point 6: 
Point 7  Advanced Calibration Point 7  Advanced Calibration
Point 8  Operation #  Point 8  Operation # 
Point 9  Point 9 
Point 10  Interval (RB/ACAL) #  Point 10  Interval (RB/ACAL) # 
<Point Cal. For No. of Correction Points  Use Master Curve   Lot Calibration <Point Cal. For No. of Correction Points  Use Master Curve   Lot Calibration
Master Curve> OD Range Master Curve> OD Range
Calibrator OD Conc Low High Stability Calibrator OD Conc Low High Stability
Point-1  Reagent Blank Day Hour Point-1  Reagent Blank Day Hour
Point-2  Calibration Day Hour Point-2  Calibration Day Hour
MB Type Factor: # 1-Point Calibration Point   with Conc-0 MB Type Factor: # 1-Point Calibration Point   with Conc-0

Enzyme BSOSR6x09.07
2018-05
AST (IFCC, with OSR60180 activition) AU5800 Serum/Plasma Application
System Reagent: OSR6009, OSR6109, OSR6209, OSR6609 Reagent ID: 009
Parameters Specific Test Parameters
General LIH ISE HbA1c Calculated Test Range

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

Sample Volume 5 L Dilution 0 L OD Limit


Pre-Dilution Rate 1  Diluent Bottle #  Min.OD 1.0 Max.OD 2.5
Rgt. Volume R1(R1-1) 25 L Dilution 10 L Reagent OD Limit
R1-2 5 L Dilution 10 L 1st. Low 1.3 High 2.5
Last Low 1.3 High 2.5
R2(R2-1) 25 L Dilution 50 L
Dynamic Range Low 3* High 1000*
Common Rgt. Type R1-2 Name # Correlation Factor A 1 B 0
Wavelength Pri 340 nm Sec. 660 nm Factor for Maker A 1 B 0
Method RATE 

SERUM/PLASMA APPLICATION
Reaction Slope -  Onboard Stability Period 30 Day 0 Hour
Measuring Point1 1st 14 Last 27 LIH Influence Check # 
Measuring Point2 1st Last Lipemia +++++ 
Linearity Limit 15 % Icterus +++++ 
Lag Time Check YES  Hemolysis + 

Parameters Specific Test Parameters


General LIH ISE HbA1c Calculated Test Range

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


□ Use Serum Cal.

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


<Calibrator Parameters> Range
Calibrator OD Conc Low High Slope Check None 
Point 1: §  § §3650* §5470*
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
Point-2  Calibration Day Hour
# User defined
MB Type Factor: # 1-Point Calibration Point  □ with Conc-0
* 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

Enzyme BSOSR6x09.07
2018-05
AST (IFCC, without Pyridoxal phosphate activation), AU400/AU640
Paediatric Application
System Reagent: OSR6009, OSR6109, OSR6209 Reagent ID: 009
Specific Test Parameters
General LIH ISE Range

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

Sample: Volume 10 L Dilution 10 L Pre-Dilution Rate: 1


Reagents: R1 Volume 50 L Dilution 50 L Min OD Max OD
R2 Volume 50 L Dilution 90 L L 0.60 H 2.5
Reagent OD limit:
Wavelength: Pri. 340  Sec. 660  First L 1.1 First H 2.5
Method: RATE  Last L 1.1 Last H 2.5
Reaction slope: -  Dynamic Range:
Measuring Point 1: First 14 Last 27 L 3* H 1000*
Measuring Point 2: First Last Correlation Factor:
Linearity : 15 % A 1 B 0
No Lag Time: YES  On-board stability period: 30

PAEDIATRIC APPLICATION
Specific Test Parameters
General LIH ISE Range

Test Name: ASTP    Type: Serum 

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: U/L* Decimal places: #

Calibration Specific
General ISE

Test Name: ASTP    Type Serum 

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

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


Point 1: § § §3650* §5470*
Point 2:
Point 3:
Point 4:
Point 5:
Point 6:
Point 7:
1-Point Cal. Point:  with CONC-0 Slope Check: None  Advanced Calibration: # 
MB Type Factor: # Calibration Stability Period:

# User defined
* 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.

Enzyme BSOSR6x09.07
2018-05
AST (IFCC, without Pyridoxal phosphate activation), AU2700/AU5400 AST (IFCC, without Pyridoxal phosphate activation), AU680/AU480
Paediatric Application
Paediatric Application System Reagent: OSR6009, OSR6109, OSR6209 Reagent ID: 009
System Reagent: OSR6009, OSR6109, OSR6209, OSR6609 Reagent ID: 009 Parameters Specific Test Parameters
Specific Test Parameters General LIH ISE HbA1c Calculated Test Range
General LIH ISE Range Test Name: ASTP    Type: Serum  Operation Yes 
Test Name: ASTP    Type: Serum  Operation: Yes 
Sample Volume 5 L Dilution 10 L OD Limit
Sample: Volume 5 L Dilution 10 L Pre-Dilution Rate: 1
Pre-Dilution Rate 1  Min.OD 0.60 Max.OD 2.5
Reagents: R1 Volume 25 L Dilution 25 L Min OD Max OD
Rgt. Volume R1(R1-1) 25 L Dilution 25 L Reagent OD Limit
R2 Volume 25 L Dilution 40 L L 0.60 H 2.5
First Low 1.1 High 2.5
Reagent OD limit: Last Low 1.1 High 2.5
Wavelength: Pri. 340  Sec. 660  First L 1.1 First H 2.5 R2(R2-1) 25 L Dilution 40 L
Method: RATE  Last L 1.1 Last H 2.5 Dynamic Range Low 3* High 1000*
Reaction slope: -  Dynamic Range: Common Rgt. Type Noneф Name ф Correlation Factor A 1 B 0
Measuring Point 1: First 14 Last 27 L 3* H 1000* Wavelength Pri 340 nm Sec. 660 nm Factor for Maker A 1 B 0
Measuring Point 2: First Last Correlation Factor: Method RATE 
Linearity : 15 % A 1 B 0 Reaction Slope -  Onboard Stability Period 30 Day 0 Hour
No Lag Time: YES  On-board stability period: 30 Measuring Point1 First 14 Last 27 LIH Influence Check # 

PAEDIATRIC APPLICATION
Measuring Point2 First Last Lipemia +++++ 
Linearity Limit 15 % Icterus +++++ 
Specific Test Parameters Lag Time Check YES  Hemolysis + 
General LIH ISE Range
Parameters Specific Test Parameters
Test Name: ASTP    Type: Serum  General LIH ISE HbA1c Calculated Test Range

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


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
 2. #  # # # # # # Sex Year Month Year Month Low High # #
 3. #  # # # # # #  1. #  # # # # # #
 4. #  # # # # # #  2. #  # # # # # #
 5. #  # # # # # #  3. #  # # # # # #
 6. #  # # # # # #  4. #  # # # # # #
7. None Selected # #  5. #  # # # # # #
8. Out of Range L H # #  6. #  # # # # # #
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: ASTP    Type Serum  Test Name: ASTP    Type Serum   Use Serum Cal.

Calibration Type: MB  Formula: Y=AX+B  Counts: # Process:  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: § § §3650* §5470* Point 1: §  § §3650* §5470*
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 # 
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
* Values set for working in U/L. To work in SI units (µkat/L) divide by 60
Point-1  Reagent Blank Day Hour
§ For use in AB mode only. Refer to IFU for further instruction
ф AU680 Point-2  Calibration Day Hour
MB Type Factor: # 1-Point Calibration Point   with Conc-0

Enzyme BSOSR6x09.07
2018-05
AST (IFCC, without Pyridoxal phosphate activition) AU5800 Paediatric Application
System Reagent: OSR6009, OSR6109, OSR6209, OSR6609 Reagent ID: 009
Parameters Specific Test Parameters
General LIH ISE HbA1c Calculated Test Range

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

Sample Volume 5 L Dilution 10 L OD Limit


Pre-Dilution Rate 1  Diluent Bottle #  Min.OD 0.60 Max.OD 2.5
Rgt. Volume R1(R1-1) 25 L Dilution 25 L Reagent OD Limit
R1-2 L Dilution L 1st. Low 1.1 High 2.5
Last Low 1.1 High 2.5
R2(R2-1) 25 L Dilution 40 L
Dynamic Range Low 3* High 1000*
Common Rgt. Type None Name None Correlation Factor A 1 B 0
Wavelength Pri 340 nm Sec. 660 nm Factor for Maker A 1 B 0
Method RATE 
Reaction Slope -  Onboard Stability Period 30 Day 0 Hour

SERUM/PLASMA APPLICATION
Measuring Point1 1st 14 Last 27 LIH Influence Check # 
Measuring Point2 1st Last Lipemia +++++ 
Linearity Limit 15 % Icterus +++++ 
Lag Time Check YES  Hemolysis + 

PAEDIATRIC APPLICATION
Parameters Specific Test Parameters
General LIH ISE HbA1c Calculated Test Range

Test Name: ASTP    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: ASTP    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: §  § §3650* §5470*
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 * 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 § For use in AB mode only, refer to IFU for further instruction

Enzyme BSOSR6x09.07
2018-05
AST (IFCC, with OE60106 activation), AU400/AU640
Paediatric Application
System Reagent: OSR6009, OSR6109, OSR6209 Reagent ID: 009

Specific Test Parameters


General LIH ISE Range

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

Sample: Volume 10 L Dilution 10 L Pre-Dilution Rate: 1


Reagents: R1 Volume 50 L Dilution 50 L Min OD Max OD
R2 Volume 50 L Dilution 90 L L 1.0 H 2.5
Reagent OD limit:
Wavelength: Pri. 340  Sec. 660  First L 1.3 First H 2.5
Method: RATE  Last L 1.3 Last H 2.5
Reaction slope: -  Dynamic Range:
Measuring Point 1: First 14 Last 27 L 3* H 1000*
Measuring Point 2: First Last Correlation Factor:
Linearity : 15 % A 1 B 0
No Lag Time: YES  On-board stability period: 7

PAEDIATRIC APPLICATION
Specific Test Parameters
General LIH ISE Range

Test Name: ASTP    Type: Serum 

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: U/L* Decimal places: #

Calibration Specific
General ISE

Test Name: ASTP    Type Serum 

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

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


Point 1: § § §3650* §5470*
Point 2:
Point 3:
Point 4:
Point 5:
Point 6:
Point 7:
1-Point Cal. Point:  with CONC-0 Slope Check: None  Advanced Calibration: # 
MB Type Factor: # Calibration Stability Period:

# User defined
* 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.
Enzyme BSOSR6x09.07
2018-05
AST (IFCC, with OE60106 activation), AU2700/AU5400 AST (IFCC, with OE60106 activition) AU5800 Paediatric Application
System Reagent: OSR6009, OSR6109, OSR6209, OSR6609 Reagent ID: 009
Paediatric Application Parameters Specific Test Parameters
System Reagent: OSR6009, OSR6109, OSR6209, OSR6609 Reagent ID: 009 General LIH ISE HbA1c Calculated Test Range

Specific Test Parameters Test Name: ASTP    Type: Serum  Operation Yes 
General LIH ISE Range

Test Name: ASTP    Type: Serum  Operation: Yes  Sample Volume 5 L Dilution 10 L OD Limit
Pre-Dilution Rate 1  Diluent Bottle #  Min.OD 1.0 Max.OD 2.5
Sample: Volume 5 L Dilution 10 L Pre-Dilution Rate: 1 Rgt. Volume R1(R1-1) 25 L Dilution 25 L Reagent OD Limit
Reagents: R1 Volume 25 L Dilution 25 L Min OD Max OD R1-2 L Dilution L 1st. Low 1.3 High 2.5
R2 Volume 25 L Dilution 40 L L 1.0 H 2.5 Last Low 1.3 High 2.5
Reagent OD limit: R2(R2-1) 25 L Dilution 40 L
Wavelength: Pri. 340  Sec. 660  First L 1.3 First H 2.5 Dynamic Range Low 3* High 1000*
Method: RATE  Last L 1.3 Last H 2.5 Common Rgt. Type None Name None Correlation Factor A 1 B 0
Reaction slope: -  Dynamic Range: Wavelength Pri 340 nm Sec. 660 nm Factor for Maker A 1 B 0
Measuring Point 1: First 14 Last 27 L 3* H 1000* Method RATE 
Measuring Point 2: First Last Correlation Factor: Reaction Slope -  Onboard Stability Period 7 Day 0 Hour
Linearity : 15 % A 1 B 0 Measuring Point1 1st 14 Last 27 LIH Influence Check # 
Measuring Point2 1st Last Lipemia +++++ 
No Lag Time: YES  On-board stability period: 7
Linearity Limit 15 % Icterus +++++ 

PAEDIATRIC APPLICATION
Lag Time Check YES  Hemolysis + 

Specific Test Parameters Parameters Specific Test Parameters


General LIH ISE Range General LIH ISE HbA1c Calculated Test Range

Test Name: ASTP    Type: Serum  Test Name: ASTP    Type: Serum 

Value/Flag: #  Level L: # Level H: # Value/Flag: # 


Normal Ranges: Age L Age H Level Low # High #
Sex Year Month Year Month L H Specific Ranges: From To
 1. #  # # # # # # Sex Year Month Year Month Low High
 2. #  # # # # # #  1. #  # # # # # #
 2. #  # # # # # #
 3. #  # # # # # #
 3. #  # # # # # #
 4. #  # # # # # #
 4. #  # # # # # #
 5. #  # # # # # #
 5. #  # # # # # #
 6. #  # # # # # #  6. #  # # # # # #
7. None Selected # # 7. Standard demographics # #
8. Out of Range L H # # 8. Not within expected values # #
Panic Value: # # Unit: U/L* Decimal places: # Panic Value Low # High # Unit U/L* Decimal Places #
Parameters Calibration Parameters
Calibrators Calibration Specific
Calibration Specific General ISE
General ISE Test Name: ASTP    Type Serum  Cuvette . 
□ Use Serum Cal.
Test Name: ASTP    Type Serum 
Calibration Type: MB  Formula: Y=AX+B  Counts: # 
Calibration Type: MB  Formula: Y=AX+B  Counts: # Process:  <Calibrator Parameters> Range
Calibrator OD Conc Low High Slope Check 
Cal. No. OD CONC Factor/OD-L Factor/OD-H
Point 1: §  § §3650* §5470*
Point 1: § § §3650* §5470*
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
* Values set for working in U/L. To work in SI units (µkat/L) divide by 60 Point-1  Reagent Blank Day Hour
§ For use in AB mode only. Refer to IFU for further instruction Point-2  Calibration Day Hour
MB Type Factor: # 1-Point Calibration Point  □ with Conc-0

Enzyme BSOSR6x09.07
2018-05
AST (IFCC, with OE60106 activation), AU680/AU480 Paediatric Application AST (IFCC, with OSR60180 activation), AU680 Paediatric Application
System Reagent: OSR6009, OSR6109, OSR6209, Reagent ID: 009 System Reagent: OSR6009, OSR6109, OSR6209 Reagent ID: 009
Parameters Specific Test Parameters Parameters Specific Test Parameters
General LIH ISE HbA1c Calculated Test Range General LIH ISE HbA1c Calculated Test Range

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

Sample Volume 5 L Dilution 10 L OD Limit Sample Volume 5 L Dilution 10 L OD Limit


Pre-Dilution Rate 1  Min.OD 1.0 Max.OD 2.5 Pre-Dilution Rate 1  Min.OD 1.0 Max.OD 2.5
Rgt. Volume R1(R1-1) 25 L Dilution 25 L Reagent OD Limit Rgt. Volume R1(R1-1) 25 L Dilution 10 L Reagent OD Limit
First Low 1.3 High 2.5 R1-2 5 L Dilution 10 L First Low 1.3 High 2.5
Last Low 1.3 High 2.5 Last Low 1.3 High 2.5
R2(R2-1) 25 L Dilution 40 L R2(R2-1) 25 L Dilution 40 L
Dynamic Range Low 3* High 1000* Dynamic Range Low 3* High 1000*
Common Rgt. Type Noneф Name ф Correlation Factor A 1 B 0 Common Rgt. Type R1-2 Name # Correlation Factor A 1 B 0
Wavelength Pri 340 nm Sec. 660 nm Factor for Maker A 1 B 0 Wavelength Pri 340 nm Sec. 660 nm Factor for Maker A 1 B 0
Method RATE  Method RATE 
Reaction Slope -  Onboard Stability Period 7 Day 0 Hour Reaction Slope -  Onboard Stability Period 30 Day 0 Hour
Measuring Point1 First 14 Last 27 LIH Influence Check #  Measuring Point1 First 14 Last 27 LIH Influence Check # 
Measuring Point2 First Last Lipemia +++++  Measuring Point2 First Last Lipemia +++++ 
Linearity Limit 15 % Icterus +++++  Linearity Limit 15 % Icterus +++++ 
Lag Time Check YES  Hemolysis +  Lag Time Check YES  Hemolysis + 

PAEDIATRIC APPLICATION
Parameters Specific Test Parameters Parameters Specific Test Parameters
General LIH ISE HbA1c Calculated Test Range General LIH ISE HbA1c Calculated Test Range

Test Name: ASTP    Type: Serum  Test Name: ASTP    Type: Serum 

Value/Flag: #  Low High Value/Flag: #  Low High


Level # # Panic Value Level # # Panic Value
Specific Ranges: From To Low High Specific Ranges: From To Low High
Sex Year Month Year Month Low High # # Sex Year Month Year Month Low High # #
 1. #  # # # # # #  1. #  # # # # # #
 2. #  # # # # # #  2. #  # # # # # #
 3. #  # # # # # #  3. #  # # # # # #
 4. #  # # # # # #  4. #  # # # # # #
 5. #  # # # # # #  5. #  # # # # # #
 6. #  # # # # # #  6. #  # # # # # #
7. No demographics # # 7. No demographics # #
8. Not within expected values # # 8. Not within expected values # #
Unit U/L* Decimal Places # Unit U/L* Decimal Places #
Parameters Calibration Parameters Parameters Calibration Parameters
Calibrators Calibration Specific STAT Table Calibration Calibrators Calibration Specific STAT Table Calibration
General ISE General ISE

Test Name: ASTP    Type Serum   Use Serum Cal. Test Name: ASTP    Type Serum   Use Serum Cal.

Calibration Type: MB  Formula: Y=AX+B  Counts: #  Calibration Type: MB  Formula: Y=AX+B  Counts: # 
<Calibrator Parameters> Range <Calibrator Parameters> Range
Calibrator OD Conc Low High Slope Check None  Calibrator OD Conc Low High Slope Check None 
Point 1: §  § §3650* §5470* Point 1: §  § §3650* §5470*
Point 2:  Allowance Range Check Point 2:  Allowance Range Check
Point 3:  Point 3: 
Point 4:   Reagent Blank Point 4:   Reagent Blank
Point 5:   Calibration Point 5:   Calibration
Point 6:  Point 6: 
Point 7  Advanced Calibration Point 7  Advanced Calibration
Point 8  Operation #  Point 8  Operation # 
Point 9  Point 9 
Point 10  Interval (RB/ACAL) #  Point 10  Interval (RB/ACAL) # 
<Point Cal. For No. of Correction Points  Use Master Curve   Lot Calibration <Point Cal. For No. of Correction Points  Use Master Curve   Lot Calibration
Master Curve> OD Range Master Curve> OD Range
Calibrator OD Conc Low High Stability Calibrator OD Conc Low High Stability
Point-1  Reagent Blank Day Hour Point-1  Reagent Blank Day Hour
Point-2  Calibration Day Hour Point-2  Calibration Day Hour
MB Type Factor: # 1-Point Calibration Point   with Conc-0 MB Type Factor: # 1-Point Calibration Point   with Conc-0

Enzyme BSOSR6x09.07
2018-05
AST (IFCC, with OSR60180 activition) AU5800 Paediatric Application
System Reagent: OSR6009, OSR6109, OSR6209, OSR6609 Reagent ID: 009
Parameters Specific Test Parameters
General LIH ISE HbA1c Calculated Test Range

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

Sample Volume 5 L Dilution 10 L OD Limit


Pre-Dilution Rate 1  Diluent Bottle #  Min.OD 1.0 Max.OD 2.5
Rgt. Volume R1(R1-1) 25 L Dilution 10 L Reagent OD Limit
R1-2 5 L Dilution 10 L 1st. Low 1.3 High 2.5
Last Low 1.3 High 2.5
R2(R2-1) 25 L Dilution 40 L
Dynamic Range Low 3* High 1000*
Common Rgt. Type R1-2 Name # Correlation Factor A 1 B 0
Wavelength Pri 340 nm Sec. 660 nm Factor for Maker A 1 B 0
Method RATE 
Reaction Slope -  Onboard Stability Period 30 Day 0 Hour
Measuring Point1 1st 14 Last 27 LIH Influence Check # 
Measuring Point2 1st Last Lipemia +++++ 
Linearity Limit 15 % Icterus +++++ 
Lag Time Check YES  Hemolysis + 

Parameters Specific Test Parameters


General LIH ISE HbA1c Calculated Test Range

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


□ Use Serum Cal.

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


<Calibrator Parameters> Range
Calibrator OD Conc Low High Slope Check None 
Point 1: §  § §3650* §5470*
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 * 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 § For use in AB mode only. Refer to IFU for further instruction

Enzyme BSOSR6x09.07
2018-05
Name: AST (IFCC,without Pyridoxal phosphate activation), DxC 700 AU Serum/Plasma Application
System Reagent: OSR6x09
Test name: AST1N Reagent ID: 009

General LIH ISE Calculated Test Range


Test Name: ▼ Type: ▼ Operation ▼
AST1N Test No Serum Yes

Sample Volume 5.0 µL Dilution 0 ▼ µL OD Limit


Pre-Dilution Rate 1 ▼ Min. OD 0.6000 Max OD 2.5000
Reagent OD Limit
Reagent Volume R1 (R1-1) 25 µL Dilution 25 µL 1st Low 1.1000 High 2.5000
R1-2 µL Dilution µL Last Low 1.1000 High 2.5000
R2 (R2-1) 25 µL Dilution 50 µL Analytical Measuring Range Low 3.00* High 1000.00*
Common Reagent Type None Name None Correlation Factor A 1 B 0

Wavelength Pri 340 ▼ nm Sec 660 ▼ nm Manufacturer Factor A 1 B 0


Method RATE ▼
Reaction Slope - ▼ Onboard Stability Period 30 Day 0 Hour
Measuring Point-1 1st 14 Last 27 LIH Influence Check # ▼
Measuring Point-2 1st Last Lipemia +++++ ▼
Linearity Limit 15 % Icterus +++++ ▼
Lag Time Check YES ▼ Hemolysis + ▼

General LIH ISE Calculated Test Range


Test Name: ▼ Type: ▼
AST1N Test No Serum

Value/Flag # ▼ Level Low # High #


Specific Ranges
From To
Sex Year Month Year Month Other Type Low High
□ 1: # ▼ # # # # None # #

□ 2: # ▼ # # # # None # #

□ 3: # ▼ # # # # None # #

□4 # ▼ # # # # None # #

□ 5: # ▼ # # # # None # #

□ 6: # ▼ # # # # None # #

7: Standard demographics # #

8: Not within expected values # #

Critical Limits Low # High # Unit U/L* Select Decimal Places #

Calibrators General ISE  


Test Name: ▼ Type: ▼
AST1N Serum
□ Use Serum Cal.
Calibration Type: MB ▼ Formula: Y=AX+B ▼ Counts: # ▼

<Calibrator Parameters> Slope Check ▼


Range
Calibrator OD Conc
Low High
Point-1 § ▼ § §3650* §5470* Allowable Range Check
Point-2 ▼ □ Reagent Blank
Point-3 ▼ □ Calibration
Point-4 ▼ Advanced Calibration
Point-5 ▼ Operation Yes ▼
Point-6 ▼
Point-7 ▼ Interval (RB) Lot ▼

MB Type Factor # 1-Point Calibration Point ▼ □ with Conc-0 Interval (ACAL) ▼

Stability
Reagent Blank Day Hour

Calibration Day Hour

# User Defined
* 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

Enzyme BSOSR6x09.07
2018-05
Name: AST (IFCC,with 60106 activation), DxC 700 AU Serum/Plasma Application
System Reagent: OSR6x09
Test name: AST2N Reagent ID: 009

General LIH ISE Calculated Test Range


Test Name: ▼ Type: ▼ Operation ▼
AST2N Test No Serum Yes

Sample Volume 5.0 µL Dilution 0 ▼ µL OD Limit


Pre-Dilution Rate 1 ▼ Min. OD 1.0000 Max OD 2.5000
Reagent OD Limit
Reagent Volume R1 (R1-1) 25 µL Dilution 25 µL 1st Low 1.3000 High 2.5000
R1-2 µL Dilution µL Last Low 1.3000 High 2.5000
R2 (R2-1) 25 µL Dilution 50 µL Analytical Measuring Range Low 3.00* High 1000.00*
Common Reagent Type None Name None Correlation Factor A 1 B 0

Wavelength Pri 340 ▼ nm Sec 660 ▼ nm Manufacturer Factor A 1 B 0


Method RATE ▼
Reaction Slope - ▼ Onboard Stability Period 7 Day 0 Hour
Measuring Point-1 1st 14 Last 27 LIH Influence Check # ▼
Measuring Point-2 1st Last Lipemia +++++ ▼
Linearity Limit 15 % Icterus +++++ ▼
Lag Time Check YES ▼ Hemolysis + ▼

General LIH ISE Calculated Test Range


Test Name: ▼ Type: ▼
AST2N Test No Serum

Value/Flag # ▼ Level Low # High #


Specific Ranges
From To
Sex Year Month Year Month Other Type Low High
□ 1: # ▼ # # # # None # #

□ 2: # ▼ # # # # None # #

□ 3: # ▼ # # # # None # #

□4 # ▼ # # # # None # #

□ 5: # ▼ # # # # None # #

□ 6: # ▼ # # # # None # #

7: Standard demographics # #

8: Not within expected values # #

Critical Limits Low # High # Unit U/L* Select Decimal Places #

Calibrators General ISE  


Test Name: ▼ Type: ▼
AST2N Serum
□ Use Serum Cal.
Calibration Type: MB ▼ Formula: Y=AX+B ▼ Counts: # ▼

<Calibrator Parameters> Slope Check ▼


Range
Calibrator OD Conc
Low High
Point-1 § ▼ § §3650* §5470* Allowable Range Check
Point-2 ▼ □ Reagent Blank
Point-3 ▼ □ Calibration
Point-4 ▼ Advanced Calibration
Point-5 ▼ Operation Yes ▼
Point-6 ▼
Point-7 ▼ Interval (RB) Lot ▼

MB Type Factor # 1-Point Calibration Point ▼ □ with Conc-0 Interval (ACAL) ▼

Stability
Reagent Blank Day Hour

Calibration Day Hour

# User Defined
* 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

Enzyme BSOSR6x09.07
2018-05
Name: AST (IFCC, with OSR60180 activation), DxC 700 AU Serum/Plasma Application
System Reagent: OSR6x09
Test name: AST3N Reagent ID: 009

General LIH ISE Calculated Test Range


Test Name: ▼ Type: ▼ Operation ▼
AST3N Test No Serum Yes

Sample Volume 5.0 µL Dilution 0 ▼ µL OD Limit


Pre-Dilution Rate 1 ▼ Min. OD 1.0000 Max OD 2.5000
Reagent OD Limit
Reagent Volume R1 (R1-1) 25 µL Dilution 10 µL 1st Low 1.3000 High 2.5000
R1-2 5 µL Dilution 10 µL Last Low 1.3000 High 2.5000
R2 (R2-1) 25 µL Dilution 50 µL Analytical Measuring Range Low 3.00* High 1000.00*
Common Reagent Type R1-2 Name # Correlation Factor A 1 B 0

Wavelength Pri 340 ▼ nm Sec 660 ▼ nm Manufacturer Factor A 1 B 0


Method RATE ▼
Reaction Slope - ▼ Onboard Stability Period 30 Day 0 Hour
Measuring Point-1 1st 14 Last 27 LIH Influence Check # ▼
Measuring Point-2 1st Last Lipemia +++++ ▼
Linearity Limit 15 % Icterus +++++ ▼
Lag Time Check YES ▼ Hemolysis + ▼

General LIH ISE Calculated Test Range


Test Name: ▼ Type: ▼
AST3N Test No Serum

Value/Flag # ▼ Level Low # High #


Specific Ranges
From To
Sex Year Month Year Month Other Type Low High
□ 1: # ▼ # # # # None # #

□ 2: # ▼ # # # # None # #

□ 3: # ▼ # # # # None # #

□4 # ▼ # # # # None # #

□ 5: # ▼ # # # # None # #

□ 6: # ▼ # # # # None # #

7: Standard demographics # #

8: Not within expected values # #

Critical Limits Low # High # Unit U/L* Select Decimal Places #

Calibrators General ISE  


Test Name: ▼ Type: ▼
AST3N Serum
□ Use Serum Cal.
Calibration Type: MB ▼ Formula: Y=AX+B ▼ Counts: # ▼

<Calibrator Parameters> Slope Check ▼


Range
Calibrator OD Conc
Low High
Point-1 § ▼ § §3650* §5470* Allowable Range Check
Point-2 ▼ □ Reagent Blank
Point-3 ▼ □ Calibration
Point-4 ▼ Advanced Calibration
Point-5 ▼ Operation Yes ▼
Point-6 ▼
Point-7 ▼ Interval (RB) Lot ▼

MB Type Factor # 1-Point Calibration Point ▼ □ with Conc-0 Interval (ACAL) ▼

Stability
Reagent Blank Day Hour

Calibration Day Hour

# User Defined
* 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

Enzyme BSOSR6x09.07
2018-05
Name: AST (IFCC,without Pyridoxal phosphate activation), DxC 700 AU Paediatric Serum Application
System Reagent: OSR6x09
Test name: AST1NP Reagent ID: 009

General LIH ISE Calculated Test Range


Test Name: ▼ Type: ▼ Operation ▼
AST1NP Test No Serum Yes

Sample Volume 5.0 µL Dilution 10 ▼ µL OD Limit


Pre-Dilution Rate 1 ▼ Min. OD 0.6000 Max OD 2.5000
Reagent OD Limit
Reagent Volume R1 (R1-1) 25 µL Dilution 25 µL 1st Low 1.1000 High 2.5000
R1-2 µL Dilution µL Last Low 1.1000 High 2.5000
R2 (R2-1) 25 µL Dilution 40 µL Analytical Measuring Range Low 3.00* High 1000.00*
Common Reagent Type None Name None Correlation Factor A 1 B 0

Wavelength Pri 340 ▼ nm Sec 660 ▼ nm Manufacturer Factor A 1 B 0


Method RATE ▼
Reaction Slope - ▼ Onboard Stability Period 30 Day 0 Hour
Measuring Point-1 1st 14 Last 27 LIH Influence Check # ▼
Measuring Point-2 1st Last Lipemia +++++ ▼
Linearity Limit 15 % Icterus +++++ ▼
Lag Time Check YES ▼ Hemolysis + ▼

General LIH ISE Calculated Test Range


Test Name: ▼ Type: ▼
AST1NP Test No Serum

Value/Flag # ▼ Level Low # High #


Specific Ranges
From To
Sex Year Month Year Month Other Type Low High
□ 1: # ▼ # # # # None # #

□ 2: # ▼ # # # # None # #

□ 3: # ▼ # # # # None # #

□4 # ▼ # # # # None # #

□ 5: # ▼ # # # # None # #

□ 6: # ▼ # # # # None # #

7: Standard demographics # #

8: Not within expected values # #

Critical Limits Low # High # Unit U/L* Select Decimal Places #

Calibrators General ISE  


Test Name: ▼ Type: ▼
AST1NP Serum
□ Use Serum Cal.
Calibration Type: MB ▼ Formula: Y=AX+B ▼ Counts: # ▼

<Calibrator Parameters> Slope Check ▼


Range
Calibrator OD Conc
Low High
Point-1 § ▼ § §3650* §5470* Allowable Range Check
Point-2 ▼ □ Reagent Blank
Point-3 ▼ □ Calibration
Point-4 ▼ Advanced Calibration
Point-5 ▼ Operation Yes ▼
Point-6 ▼
Point-7 ▼ Interval (RB) Lot ▼

MB Type Factor # 1-Point Calibration Point ▼ □ with Conc-0 Interval (ACAL) ▼

Stability
Reagent Blank Day Hour

Calibration Day Hour

# User Defined
* 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

Enzyme BSOSR6x09.07
2018-05
Name: AST (IFCC, with 60106 activation), DxC 700 AU Paediatric Serum Application
System Reagent: OSR6x09
Test name: AST2NP Reagent ID: 009

General LIH ISE Calculated Test Range


Test Name: ▼ Type: ▼ Operation ▼
AST2NP Test No Serum Yes

Sample Volume 5.0 µL Dilution 10 ▼ µL OD Limit


Pre-Dilution Rate 1 ▼ Min. OD 1.0000 Max OD 2.5000
Reagent OD Limit
Reagent Volume R1 (R1-1) 25 µL Dilution 25 µL 1st Low 1.3000 High 2.5000
R1-2 µL Dilution µL Last Low 1.3000 High 2.5000
R2 (R2-1) 25 µL Dilution 40 µL Analytical Measuring Range Low 3.00* High 1000.00*
Common Reagent Type None Name None Correlation Factor A 1 B 0

Wavelength Pri 340 ▼ nm Sec 660 ▼ nm Manufacturer Factor A 1 B 0


Method RATE ▼
Reaction Slope - ▼ Onboard Stability Period 7 Day 0 Hour
Measuring Point-1 1st 14 Last 27 LIH Influence Check # ▼
Measuring Point-2 1st Last Lipemia +++++ ▼
Linearity Limit 15 % Icterus +++++ ▼
Lag Time Check YES ▼ Hemolysis + ▼

General LIH ISE Calculated Test Range


Test Name: ▼ Type: ▼
AST2NP Test No Serum

Value/Flag # ▼ Level Low # High #


Specific Ranges
From To
Sex Year Month Year Month Other Type Low High
□ 1: # ▼ # # # # None # #

□ 2: # ▼ # # # # None # #

□ 3: # ▼ # # # # None # #

□4 # ▼ # # # # None # #

□ 5: # ▼ # # # # None # #

□ 6: # ▼ # # # # None # #

7: Standard demographics # #

8: Not within expected values # #

Critical Limits Low # High # Unit U/L* Select Decimal Places #

Calibrators General ISE  


Test Name: ▼ Type: ▼
AST2NP Serum
□ Use Serum Cal.
Calibration Type: MB ▼ Formula: Y=AX+B ▼ Counts: # ▼

<Calibrator Parameters> Slope Check ▼


Range
Calibrator OD Conc
Low High
Point-1 § ▼ § §3650* §5470* Allowable Range Check
Point-2 ▼ □ Reagent Blank
Point-3 ▼ □ Calibration
Point-4 ▼ Advanced Calibration
Point-5 ▼ Operation Yes ▼
Point-6 ▼
Point-7 ▼ Interval (RB) Lot ▼

MB Type Factor # 1-Point Calibration Point ▼ □ with Conc-0 Interval (ACAL) ▼

Stability
Reagent Blank Day Hour

Calibration Day Hour

# User Defined
* 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

Enzyme BSOSR6x09.07
2018-05
Name: AST (IFCC,with OSR60180 activation), DxC 700 AU Serum/Plasma Paediatric Application
System Reagent: OSR6x09
Test name: AST3NP Reagent ID: 009

General LIH ISE Calculated Test Range


Test Name: ▼ Type: ▼ Operation ▼
AST3NP Test No Serum Yes

Sample Volume 5.0 µL Dilution 10 ▼ µL OD Limit


Pre-Dilution Rate 1 ▼ Min. OD 1.0000 Max OD 2.5000
Reagent OD Limit
Reagent Volume R1 (R1-1) 25 µL Dilution 10 µL 1st Low 1.3000 High 2.5000
R1-2 5 µL Dilution 10 µL Last Low 1.3000 High 2.5000
R2 (R2-1) 25 µL Dilution 40 µL Analytical Measuring Range Low 3.00* High 1000.00*
Common Reagent Type R1-2 Name # Correlation Factor A 1 B 0

Wavelength Pri 340 ▼ nm Sec 660 ▼ nm Manufacturer Factor A 1 B 0


Method RATE ▼
Reaction Slope - ▼ Onboard Stability Period 30 Day 0 Hour
Measuring Point-1 1st 14 Last 27 LIH Influence Check # ▼
Measuring Point-2 1st Last Lipemia +++++ ▼
Linearity Limit 15 % Icterus +++++ ▼
Lag Time Check YES ▼ Hemolysis + ▼

General LIH ISE Calculated Test Range


Test Name: ▼ Type: ▼
AST3NP Test No Serum

Value/Flag # ▼ Level Low # High #


Specific Ranges
From To
Sex Year Month Year Month Other Type Low High
□ 1: # ▼ # # # # None # #

□ 2: # ▼ # # # # None # #

□ 3: # ▼ # # # # None # #

□4 # ▼ # # # # None # #

□ 5: # ▼ # # # # None # #

□ 6: # ▼ # # # # None # #

7: Standard demographics # #

8: Not within expected values # #

Critical Limits Low # High # Unit U/L* Select Decimal Places #

Calibrators General ISE  


Test Name: ▼ Type: ▼
AST3NP Serum
□ Use Serum Cal.
Calibration Type: MB ▼ Formula: Y=AX+B ▼ Counts: # ▼

<Calibrator Parameters> Slope Check ▼


Range
Calibrator OD Conc
Low High
Point-1 § ▼ § §3650* §5470* Allowable Range Check
Point-2 ▼ □ Reagent Blank
Point-3 ▼ □ Calibration
Point-4 ▼ Advanced Calibration
Point-5 ▼ Operation Yes ▼
Point-6 ▼
Point-7 ▼ Interval (RB) Lot ▼

MB Type Factor # 1-Point Calibration Point ▼ □ with Conc-0 Interval (ACAL) ▼

Stability
Reagent Blank Day Hour

Calibration Day Hour

# User Defined
* 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

Enzyme BSOSR6x09.07
2018-05

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