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BSOSR6X0708

This document provides information on test parameters and specifications for measuring alanine aminotransferase (ALT) levels using a particular clinical chemistry analyzer system. It lists details like sample volume and reagent volumes needed, wavelengths used, calibration details including number of calibrator points, and reference ranges. The test is for serum or plasma samples and measures ALT activity rate kinetically over 27 seconds using a multi-point calibration and primary and secondary wavelengths of 340nm and 660nm respectively.

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xuanhungyte
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© © All Rights Reserved
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0% found this document useful (0 votes)
50 views

BSOSR6X0708

This document provides information on test parameters and specifications for measuring alanine aminotransferase (ALT) levels using a particular clinical chemistry analyzer system. It lists details like sample volume and reagent volumes needed, wavelengths used, calibration details including number of calibrator points, and reference ranges. The test is for serum or plasma samples and measures ALT activity rate kinetically over 27 seconds using a multi-point calibration and primary and secondary wavelengths of 340nm and 660nm respectively.

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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ALT (IFCC, without Pyridoxal phosphate activation) AU680/AU480

Serum/Plasma Application
System Reagent: OSR6007, OSR6107 Reagent ID: 007
Parameters Specific Test Parameters
General LIH ISE HbA1c Calculated Test Range

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

Sample Volume 5 L Dilution 0 L OD Limit


Pre-Dilution Rate 1  Min.OD 0.60 Max.OD 2.5
Rgt. Volume R1(R1-1) 50 L Dilution 25 L Reagent OD Limit
First Low 1.1 High 2.5
Last Low 1.1 High 2.5
R2(R2-1) 25 L Dilution 25 L
Dynamic Range Low 3* High 500*
Common Rgt. Type Noneф Name ф 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 First 14 Last 27 LIH Influence Check # 
Measuring Point2 First Last Lipemia +++++ 
Linearity Limit 15 % Icterus +++++ 
Lag Time Check YES  Hemolysis +++++ 

Parameters Specific Test Parameters


General LIH ISE HbA1c Calculated Test Range

Test Name: ALT    Type: Serum 

Value/Flag: #  Low High


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

Test Name: ALT    Type Serum   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
MB Type Factor: # 1-Point Calibration Point   with Conc-0

# 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.
Ф AU680

Enzyme BSOSR6x07.08
2022-11
ALT (IFCC, without Pyridoxal phosphate activation) AU5800 Serum/Plasma Application
System Reagent: OSR6007, OSR6107, OSR6607 Reagent ID: 007
Parameters Specific Test Parameters
General LIH ISE HbA1c Calculated Test Range

Test Name: ALT    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) 50 L Dilution 25 L Reagent OD Limit
L L
st
R1-2 Dilution 1 . Low 1.1 High 2.5
Last Low 1.1 High 2.5
R2(R2-1) 25 L Dilution L
25
Dynamic Range Low 3* High 500*
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
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: ALT    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: ALT    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
Point-2  Calibration Day Hour
MB Type Factor: # 1-Point Calibration Point  □ with Conc-0

# 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 BSOSR6x07.08
2022-11
Name: ALT (IFCC, without Pyridoxal phosphate activation), DxC 700 AU Serum/Plasma Application
System Reagent: OSR6x07
Test name: ALT1N Reagent ID: 007

General LIH ISE Calculated Test Range


Test Name: ▼ Type: ▼ Operation ▼
ALT1N 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) 50 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 25 µL Analytical Measuring Range Low 3.00* High 500.00*
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: ▼
ALT1N 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: ▼
ALT1N 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 BSOSR6x07.08
2022-11
ALT (IFCC, with 60106 activation), AU680/AU480 Serum/Plasma Application
System Reagent: OSR6007, OSR6107 Reagent ID: 007
Parameters Specific Test Parameters
General LIH ISE HbA1c Calculated Test Range

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

Sample Volume 5 L Dilution 0 L OD Limit


Pre-Dilution Rate 1  Min.OD 1.0 Max.OD 2.5
Rgt. Volume R1(R1-1) 50 L Dilution 25 L Reagent OD Limit
First Low 1.3 High 2.5
Last Low 1.3 High 2.5
R2(R2-1) 25 L Dilution 25 L
Dynamic Range Low 3* High 500*
Common Rgt. Type Noneф Name ф 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 7 Day 0 Hour
Measuring Point1 First 14 Last 27 LIH Influence Check # 
Measuring Point2 First Last Lipemia +++++ 
Linearity Limit 15 % Icterus +++++ 
Lag Time Check YES  Hemolysis +++++ 

Parameters Specific Test Parameters


General LIH ISE HbA1c Calculated Test Range

Test Name: ALT    Type: Serum 

Value/Flag: #  Low High


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

Test Name: ALT    Type Serum   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
MB Type Factor: # 1-Point Calibration Point   with Conc-0

# 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.
Ф AU680

Enzyme BSOSR6x07.08
2022-11
ALT (IFCC, with 60106 activition) AU5800 Serum/Plasma Application
System Reagent: OSR6007, OSR6107, OSR6607 Reagent ID: 007
Parameters Specific Test Parameters
General LIH ISE HbA1c Calculated Test Range

Test Name: ALT    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) 50 L Dilution 25 L Reagent OD Limit
R1-2 L Dilution L 1st. Low 1.3 High 2.5
Last Low 1.3 High 2.5
R2(R2-1) 25 L Dilution 25 L
Dynamic Range Low 3* High 500*
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 7 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: ALT    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: ALT    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
Point-2  Calibration Day Hour
MB Type Factor: # 1-Point Calibration Point  □ with Conc-0

# 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 BSOSR6x07.08
2022-11
Name: ALT (IFCC, with 60106 activation), DxC 700 AU Serum/Plasma Application
System Reagent: OSR6x07
Test name: ALT2N Reagent ID: 007

General LIH ISE Calculated Test Range


Test Name: ▼ Type: ▼ Operation ▼
ALT2N 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) 50 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 25 µL Analytical Measuring Range Low 3.00* High 500.00*
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: ▼
ALT2N 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: ▼
ALT2N 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 BSOSR6x07.08
2022-11
ALT (IFCC, with OSR60180 activation), AU680 Serum/Plasma Application
System Reagent: OSR6007, OSR6107 Reagent ID: 007
Parameters Specific Test Parameters
General LIH ISE HbA1c Calculated Test Range

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

Sample Volume 5 L Dilution 0 L OD Limit


Pre-Dilution Rate 1  Min.OD 1.0 Max.OD 2.5
Rgt. Volume R1(R1-1) 50 L Dilution 10 L Reagent OD Limit
R1-2 5 L Dilution 10 L First Low 1.3 High 2.5
Last Low 1.3 High 2.5
R2(R2-1) 25 L Dilution 25 L
Dynamic Range Low 3* High 500*
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 First 14 Last 27 LIH Influence Check # 
Measuring Point2 First Last Lipemia +++++ 
Linearity Limit 15 % Icterus +++++ 
Lag Time Check YES  Hemolysis +++++ 

Parameters Specific Test Parameters


General LIH ISE HbA1c Calculated Test Range

Test Name: ALT    Type: Serum 

Value/Flag: #  Low High


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

Test Name: ALT    Type Serum   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
MB Type Factor: # 1-Point Calibration Point   with Conc-0

# 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 BSOSR6x07.08
2022-11
ALT (IFCC, with OSR60180 activition) AU5800 Serum/Plasma Application
System Reagent: OSR6007, OSR6107, OSR6607 Reagent ID: 007
Parameters Specific Test Parameters
General LIH ISE HbA1c Calculated Test Range

Test Name: ALT    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) 50 L Dilution 10 L Reagent OD Limit
L L
st
R1-2 5 Dilution 10 1 . Low 1.3 High 2.5
Last Low 1.3 High 2.5
R2(R2-1) 25 L Dilution 25 L
Dynamic Range Low 3* High 500*
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: ALT    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: ALT    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
MB Type Factor: # 1-Point Calibration Point  □ with Conc-0

# 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 BSOSR6x07.08
2022-11
Name: ALT (IFCC, with OSR60180 activation), DxC 700 AU Serum/Plasma Application
System Reagent: OSR6x07
Test name: ALT3N Reagent ID: 007

General LIH ISE Calculated Test Range


Test Name: ▼ Type: ▼ Operation ▼
ALT3N 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) 50 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 25 µL Analytical Measuring Range Low 3.00* High 500.00*
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: ▼
ALT3N 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: ▼
ALT3N 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 BSOSR6x07.08
2022-11
ALT (IFCC, without Pyrioxal phosphate activation), AU680/AU480
Low sample volume Application
System Reagent: OSR6007, OSR6107 Reagent ID: 007
Parameters Specific Test Parameters
General LIH ISE HbA1c Calculated Test Range

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

Sample Volume 5 L Dilution 10 L OD Limit


Pre-Dilution Rate 1  Min.OD 0.60 Max.OD 2.5
Rgt. Volume R1(R1-1) 50 L Dilution 25 L Reagent OD Limit
First Low 1.1 High 2.5
Last Low 1.1 High 2.5
R2(R2-1) 25 L Dilution 15 L
Dynamic Range Low 3* High 500*
Common Rgt. Type Noneф Name ф 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 First 14 Last 27 LIH Influence Check # 
Measuring Point2 First Last Lipemia +++++ 
Linearity Limit 15 % Icterus +++++ 
Lag Time Check YES  Hemolysis +++++ 

Parameters Specific Test Parameters


General LIH ISE HbA1c Calculated Test Range

Test Name: ALTP    Type: Serum 

Value/Flag: #  Low High


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

Test Name: ALTP    Type Serum   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
MB Type Factor: # 1-Point Calibration Point   with Conc-0

# 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.
Ф AU680

Enzyme BSOSR6x07.08
2022-11
ALT (IFCC, without Pyridoxal phosphate activition) AU5800
Low sample volume Application
System Reagent: OSR6007, OSR6107, OSR6607 Reagent ID: 007
Parameters Specific Test Parameters
General LIH ISE HbA1c Calculated Test Range

Test Name: ALTP    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) 50 L Dilution 25 L Reagent OD Limit
L L
st
R1-2 Dilution 1 . Low 1.1 High 2.5
Last Low 1.1 High 2.5
R2(R2-1) 25 L Dilution 15 L
Dynamic Range Low 3* High 500*
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
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: ALTP    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: ALTP    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
Point-2  Calibration Day Hour
MB Type Factor: # 1-Point Calibration Point  □ with Conc-0

# 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 BSOSR6x07.08
2022-11
Name: ALT (IFCC, without Pyridoxal phosphate activation), DxC 700 AU
Low sample volume Serum/Plasma Application
System Reagent: OSR6x07
Test name: ALT1NP Reagent ID: 007

General LIH ISE Calculated Test Range


Test Name: ▼ Type: ▼ Operation ▼
ALT1NP 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) 50 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 15 µL Analytical Measuring Range Low 3.00* High 500.00*
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: ▼
ALT1NP 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: ▼
ALT1NP 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 BSOSR6x07.08
2022-11
ALT (IFCC, with 60106 activation), AU680/AU480
Low sample volume Application
System Reagent: OSR6007, OSR6107 Reagent ID: 007
Parameters Specific Test Parameters
General LIH ISE HbA1c Calculated Test Range

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

Sample Volume 5 L Dilution 10 L OD Limit


Pre-Dilution Rate 1  Min.OD 1.0 Max.OD 2.5
Rgt. Volume R1(R1-1) 50 L Dilution 25 L Reagent OD Limit
First Low 1.3 High 2.5
Last Low 1.3 High 2.5
R2(R2-1) 25 L Dilution 15 L
Dynamic Range Low 3* High 500*
Common Rgt. Type Noneф Name ф 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 7 Day 0 Hour
Measuring Point1 First 14 Last 27 LIH Influence Check # 
Measuring Point2 First Last Lipemia +++++ 
Linearity Limit 15 % Icterus +++++ 
Lag Time Check YES  Hemolysis +++++ 

Parameters Specific Test Parameters


General LIH ISE HbA1c Calculated Test Range

Test Name: ALTP    Type: Serum 

Value/Flag: #  Low High


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

Test Name: ALTP    Type Serum   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
MB Type Factor: # 1-Point Calibration Point   with Conc-0

# 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.
Ф AU680

Enzyme BSOSR6x07.08
2022-11
ALT (IFCC, with 60106 activition) AU5800
Low sample volume Application
System Reagent: OSR6007, OSR6107, OSR6607 Reagent ID: 007
Parameters Specific Test Parameters
General LIH ISE HbA1c Calculated Test Range

Test Name: ALTP    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) 50 L Dilution 25 L Reagent OD Limit
R1-2 L Dilution L 1st. Low 1.3 High 2.5
Last Low 1.3 High 2.5
R2(R2-1) 25 L Dilution 15 L
Dynamic Range Low 3* High 500*
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 7 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: ALTP    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: ALTP    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
Point-2  Calibration Day Hour
MB Type Factor: # 1-Point Calibration Point  □ with Conc-0

# 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 BSOSR6x07.08
2022-11
Name: ALT (IFCC, with 60106 activation), DxC 700 AU
Low sample volume Serum/Plasma Application
System Reagent: OSR6x07
Test name: ALT2NP Reagent ID: 007

General LIH ISE Calculated Test Range


Test Name: ▼ Type: ▼ Operation ▼
ALT2NP 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) 50 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 15 µL Analytical Measuring Range Low 3.00* High 500.00*
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: ▼
ALT2NP 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: ▼
ALT2NP 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 BSOSR6x07.08
2022-11
ALT (IFCC, with OSR60180 activation), AU680
Low sample volume Application
System Reagent: OSR6007, OSR6107 Reagent ID: 007
Parameters Specific Test Parameters
General LIH ISE HbA1c Calculated Test Range

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

Sample Volume 5 L Dilution 10 L OD Limit


Pre-Dilution Rate 1  Min.OD 1.0 Max.OD 2.5
Rgt. Volume R1(R1-1) 50 L Dilution 10 L Reagent OD Limit
R1-2 5 L Dilution 10 L First Low 1.3 High 2.5
Last Low 1.3 High 2.5
R2(R2-1) 25 L Dilution 15 L
Dynamic Range Low 3* High 500*
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 First 14 Last 27 LIH Influence Check # 
Measuring Point2 First Last Lipemia +++++ 
Linearity Limit 15 % Icterus +++++ 
Lag Time Check YES  Hemolysis +++++ 

Parameters Specific Test Parameters


General LIH ISE HbA1c Calculated Test Range

Test Name: ALTP    Type: Serum 

Value/Flag: #  Low High


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

Test Name: ALTP    Type Serum   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
MB Type Factor: # 1-Point Calibration Point   with Conc-0

# 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 BSOSR6x07.08
2022-11
ALT (IFCC, with OSR60180 activition) AU5800
Low sample volume Application
System Reagent: OSR6007, OSR6107, OSR6607 Reagent ID: 007
Parameters Specific Test Parameters
General LIH ISE HbA1c Calculated Test Range

Test Name: ALTP    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) 50 L Dilution 10 L Reagent OD Limit
L L
st
R1-2 5 Dilution 10 1 . Low 1.3 High 2.5
Last Low 1.3 High 2.5
R2(R2-1) 25 L Dilution 15 L
Dynamic Range Low 3* High 500*
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: ALTP    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: ALTP    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
MB Type Factor: # 1-Point Calibration Point  □ with Conc-0

# 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 BSOSR6x07.08
2022-11
Name: ALT (IFCC, with OSR60180 activation), DxC 700 AU
Low sample volume Serum/Plasma Application
System Reagent: OSR6x07
Test name: ALT3NP Reagent ID: 007

General LIH ISE Calculated Test Range


Test Name: ▼ Type: ▼ Operation ▼
ALT3NP 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) 50 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 15 µL Analytical Measuring Range Low 3.00* High 500.00*
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: ▼
ALT3NP 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: ▼
ALT3NP 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 BSOSR6x07.08
2022-11

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