olympus au 600 - asterisco...olympus au 2700/5400 specific test parameters – reagent id: 004...
TRANSCRIPT
845 0441 10 02 26 July 2007/2
OLYMPUS AU 600 Specific Test Parameters – Reagent ID: 004 General Test Name ALP Type Serum Operation Yes
Sample Volume 2.5 µl Dilution 0 µl
Reagents R1 Volume 120 µl Dilution 0 µl
R2 Volume 30 µl Dilution 0 µl
Wavelength Pri 410 Sec 480 Method RATE Reaction Slope + Measuring point 1 First 14 Last 25 Measuring point 2 First Last Linearity 15 % No-Lag-Time Pre-dilution Rate Min OD Max OD -0.1000 1.200 Reagent OD Limit First L -0.1000 First H 1.400 Last L -0.1000 Last H 1.400 Dynamic Range
L 0 H 770 Correlation Factor
A 1.000 B 0.000 On-board stability period 40 Days
Value/Flag # Level L # Level H # Normal Ranges Age L Age H Sex Year Month Year Month 1 # # # # # 2 # # # # # 3 # # # # # 4 # # # # # 5 # # # # # 6 # # # # # 7 # # # # #
L H Panic Value # # Unit U/l
Calibration Type AB Formula Y=AX+B Counts # Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 Point 3 Point 4 Point 5 Point 6 Point 7 1-Point Cal. Point MB Type Factor Calibration Stability Period #) Data entry by the user *) Enter calibration or standard value and position
ALKALINE PHOSPHATASE FS
IFCC 37° C Order information Cat. No. 1 0441 .. .. … Notes 1. Please refer to the package insert for Alkaline
phosphatase FS IFCC FS for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at
least 40 days provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 0441 10 02 26 July 2007/2
OLYMPUS AU 400/640 Specific Test Parameters – Reagent ID: 004 General Test Name ALP Type Serum Operation Yes
Sample Volume 2.5 µl Dilution 0 µl
Reagents R1 Volume 120 µl Dilution 0 µl
R2 Volume 30 µl Dilution 0 µl
Wavelength Pri 410 Sec 480 Method RATE Reaction Slope + Measuring point 1 First 14 Last 25 Measuring point 2 First Last Linearity 15 % No-Lag-Time Pre-dilution Rate Min OD Max OD -0.1000 1.200 Reagent OD Limit First L -0.1000 First H 1.400 Last L -0.1000 Last H 1.400 Dynamic Range
L 0 H 770 Correlation Factor
A 1.000 B 0.000 On-board stability period 40 Days
Value/Flag # Level L # Level H # Normal Ranges Age L Age H Sex Year Month Year Month 1 # # # # # 2 # # # # # 3 # # # # # 4 # # # # # 5 # # # # # 6 # # # # # 7 # # # # #
L H Panic Value # # Unit U/l
Calibration Type AB Formula Y=AX+B Counts # Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 Point 3 Point 4 Point 5 Point 6 Point 7 1-Point Cal. Point MB Type Factor Calibration Stability Period #) Data entry by the user *) Enter calibration or standard value and position
OLYMPUS AU 2700/5400 Specific Test Parameters – Reagent ID: 004 General Test Name ALP Type Serum Operation Yes
Sample Volume 2.0 µl Dilution 0 µl
Reagents R1 Volume 100 µl Dilution 0 µl
R2 Volume 25 µl Dilution 0 µl
Wavelength Pri 410 Sec 480 Method RATE Reaction Slope + Measuring point 1 First 14 Last 25 Measuring point 2 First Last Linearity 15 % No-Lag-Time Pre-dilution Rate Min OD Max OD -0.1000 1.200 Reagent OD Limit First L -0.1000 First H 1.400 Last L -0.1000 Last H 1.400 Dynamic Range
L 0 H 800 Correlation Factor
A 1.000 B 0.000 On-board stability period 40 Days
Value/Flag # Level L # Level H # Normal Ranges Age L Age H Sex Year Month Year Month 1 # # # # # 2 # # # # # 3 # # # # # 4 # # # # # 5 # # # # # 6 # # # # # 7 # # # # #
L H Panic Value # # Unit U/l
Calibration Type AB Formula Y=AX+B Counts # Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 Point 3 Point 4 Point 5 Point 6 Point 7 1-Point Cal. Point MB Type Factor Calibration Stability Period #) Data entry by the user *) Enter calibration or standard value and position
845 3021 10 02 21 July 2001/3
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name UA Type Serum Operation Yes
Sample Volume 3.5 µl Dilution 0 µl
Reagents R1 Volume 140 µl Dilution 0 µl
R2 Volume 35 µl Dilution 0 µl
Wavelength Pri 520 Sec 700
Method END
Reaction Slope +
Measuring point 1 First 0 Last 27
Measuring point 2 First Last
Linearity %
No-Lag-Time
Pre-dilution Rate
Min OD Max OD
Reagent OD Limit
First L -0.100 First H 2.50
Last L -0.100 Last H 2.50
Dynamic Range
L 0.0 H 20.0
Correlation Factor
A 1 B 0
On-board stability period 30 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit mg/dl
Calibration Type AB Formula Y=AX+B Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * *
Point 3 * * Point 4 * * Point 5 * * Point 6 * * Point 7 * *
1-Point Cal. Point
MB Type Factor Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
URIC ACID FS TBHBA Order information Cat. No. 1 3021 .. .. …
Notes
1. Please refer to the package insert for Uric Acid FS TBHBA
for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**Applications developed before December 2003 had been used at a variety of customer laboratories and are validated by use. Software upgrades at specific analysers may require further adjustments as they are out of our control
July 2001/3
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name ALB Type Serum Operation Yes
Sample Volume 2.0 µl Dilution 0 µl
Reagents R1 Volume 200 µl Dilution 0 µl
R2 Volume 0 µl Dilution 0 µl
Wavelength Pri 600 Sec 700
Method END
Reaction Slope +
Measuring point 1 First 0 Last 8
Measuring point 2 First Last
Linearity %
No-Lag-Time
Pre-dilution Rate
Min OD Max OD
Reagent OD Limit
First L -0.1000 First H 2.00
Last L -0.1000 Last H 2.00
Dynamic Range
L 1.0 H 6.0
Correlation Factor
A 1 B 0
On-board stability period 30 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit g/dl
Calibration Type AB Formula Y=AX+B Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * * Point 3 * *
Point 4 * * Point 5 * * Point 6 * * Point 7 * *
1-Point Cal. Point
MB Type Factor Calibration Stability Period 30
#) Data entry by the user *) Enter calibration or standard value and position
ALBUMIN FS Order information Cat. No. 1 0220 .. .. …
Notes
1. Please refer to the package insert for Albumin FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**Applications developed before December 2003 had been
used at a variety of customer laboratories and are validated by use. Software upgrades at specific analysers may require further adjustments as they are out of our control
845 0220 10 02 21
July 2001/3
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name APOA Type Serum Operation Yes
Sample Volume 2.0 µl Dilution 0 µl
Reagents R1 Volume 250 µl Dilution 0 µl
R2 Volume 50 µl Dilution 0 µl
Wavelength Pri 570 Sec 800
Method END
Reaction Slope +
Measuring point 1 First 0 Last 27
Measuring point 2 First 0 Last 10
Linearity %
No-Lag-Time
Pre-dilution Rate
Min OD Max OD
Reagent OD Limit
First L 0.00 First H 2.50
Last L 0.00 Last H 2.50
Dynamic Range
L 2.5 H 250
Correlation Factor
A 1 B 0
On-board stability period 30 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit mg/dl
Calibration Type AB Formula Y=AX+B Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * * Point 3 * *
Point 4 * * Point 5 * * Point 6 * * Point 7 * *
1-Point Cal. Point
MB Type Factor Calibration Stability Period 14
#) Data entry by the user *) Enter calibration or standard value and position
APOLIPOPROTEIN A1 FS Order information Cat. No. 1 7102 .. .. …
Notes
1. Please refer to the package insert for Apoliporotein A1 FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**Applications developed before December 2003 had been
used at a variety of customer laboratories and are validated by use. Software upgrades at specific analysers may require further adjustments as they are out of our control
845 7102 10 02 21
July 2001/3
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name APOB Type Serum Operation Yes
Sample Volume 2.0 µl Dilution 0 µl
Reagents R1 Volume 200 µl Dilution 0 µl
R2 Volume 40 µl Dilution 0 µl
Wavelength Pri 340 Sec 700
Method END
Reaction Slope +
Measuring point 1 First 0 Last 27
Measuring point 2 First 0 Last 10
Linearity %
No-Lag-Time
Pre-dilution Rate
Min OD Max OD
Reagent OD Limit
First L 0.00 First H 2.50
Last L 0.00 Last H 2.50
Dynamic Range
L 0 H 250
Correlation Factor
A 1 B 0
On-board stability period 30 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit mg/dl
Calibration Type AB Formula Y=AX+B Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * *
Point 3 * * Point 4 * * Point 5 * * Point 6 * * Point 7 * *
1-Point Cal. Point
MB Type Factor Calibration Stability Period 14
#) Data entry by the user *) Enter calibration or standard value and position
APOLIPOPROTEIN B FS Order information Cat. No. 1 7112 .. .. …
Notes
1. Please refer to the package insert for Apoliporotein B FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**Applications developed before December 2003 had been
used at a variety of customer laboratories and are validated by use. Software upgrades at specific analysers may require further adjustments as they are out of our control
845 7112 10 02 21
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name GLUC Type Serum Operation Yes
Sample Volume 2.0 µ
l Dilution 0 µl
Reagents R1 Volume 160 µl
Dilution 0 µl
R2 Volume 40 µl
Dilution 0 µl
Wavelength Pri 340 Sec 380 Method END Reaction Slope + Measuring point 1 First 0 Last 27 Measuring point 2 First 0 Last 10 Linearity % No-Lag-Time Pre-dilution Rate Min OD Max OD
Reagent OD Limit First L -0.100 First H 2.50 Last L -0.100 Last H 2.50 Dynamic Range
L 0 H 900 Correlation Factor
A 1 B 0 On-board stability period 30 Days Value/Flag # Level L # Level H # Normal Ranges Age L Age H Se
x Year Month Year Month
1 # # # # #
2 # # # # # 3 # # # # # 4 # # # # # 5 # # # # # 6 # # # # # 7 # # # # # L H Panic Value # # Unit mg/dl Calibration Type AB Formula Y=AX+B Counts # Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * * Point 3 * * Point 4 * * Point 5 * * Point 6 * * Point 7 * * 1-Point Cal. Point
MB Type Factor Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
GLUCOSE HEXOKINASE FS
Order information Cat. No. Kit size 10 251 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3ml Std
1 2511 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml
10 251 023 R1 1 x 800 ml + R2 1 x 200 ml
10 250 030 6 x 3 ml standard
Notes
1. Please refer to the package insert for
Glucose Hexokinase FS for the detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics concerning; Measuring Range Specificity/Interferences Sensitivity/Limit of Detection
Precision (Reproducibility, Repeatability)
Method Comparison Reference Ranges Literature 2. The stability of the reagent on board the
analyser is at least one month provided that contamination and evaporation are avoided
3. Manufactured by
DiaSys Diagnostic Systems GmbH & Co.KG Alte Strasse 9, 65558 Holzheim, Germany
February 2000/1
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name TRF Type Serum Operation Yes
Sample Volume 2.0 µ
l Dilution 0 µl
Reagents R1 Volume 250 µl
Dilution 0 µl
R2 Volume 50 µl
Dilution 0 µl
Wavelength Pri 570 Sec 700 Method END Reaction Slope + Measuring point 1 First 0 Last 27 Measuring point 2 First 0 Last 10 Linearity % No-Lag-Time Pre-dilution Rate Min OD Max OD
Reagent OD Limit First L -0.100 First H 2.50 Last L -0.100 Last H 2.50 Dynamic Range
L 50 H 800 Correlation Factor
A 1 B 0 On-board stability period 30 Days Value/Flag # Level L # Level H # Normal Ranges Age L Age H Se
x Year Month Year Month
1 # # # # #
2 # # # # # 3 # # # # # 4 # # # # # 5 # # # # # 6 # # # # # 7 # # # # # L H Panic Value # # Unit mg/dl Calibration Type AB Formula Y=AX+B Counts # Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * * Point 3 * * Point 4 * * Point 5 * * Point 6 * * Point 7 * * 1-Point Cal. Point
MB Type Factor Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
TRANSFERRIN FS
Order information Cat. No. Kit size 1 7252 99 10 021 R1 5 x 25 ml + R2 1 x 25 ml
1 7252 99 10 023 R1 1 x 1000ml + R2 1 x 200 ml 1 7252 99 10 730 R1 4 x 20 ml + R2 2 x 8 ml
5 9200 99 10 039 5 x 1 ml TruCal Protein: Calibrator set with 5 different levels
5 9200 99 10 037 3 x 1 ml TruCal Protein high Single calibrator for auto-dilution
Notes
1. Please refer to the package insert for
Transferrin FS for the detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics concerning; Measuring Range Specificity/Interferences Sensitivity/Limit of Detection
Precision (Reproducibility, Repeatability)
Method Comparison Reference Ranges Literature 2. The stability of the reagent on board the
analyser is at least one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH & Co.KG Alte Strasse 9, 65558 Holzheim, Germany.
Oct 2000/1
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name UA Type Serum Operation Yes
Sample Volume 3.5 µ
l Dilution 0 µl
Reagents R1 Volume 160 µl
Dilution 0 µl
R2 Volume 40 µl
Dilution 0 µl
Wavelength Pri 540 Sec 700 Method END Reaction Slope + Measuring point 1 First Last Measuring point 2 First Last Linearity % No-Lag-Time Pre-dilution Rate Min OD Max OD
Reagent OD Limit First L -0.100 First H 2.50 Last L -0.100 Last H 2.50 Dynamic Range
L 0.0 H 20.0 Correlation Factor
A 1 B 0 On-board stability period 30 Days Value/Flag # Level L # Level H # Normal Ranges Age L Age H Se
x Year Month Year Month
1 # # # # #
2 # # # # # 3 # # # # # 4 # # # # # 5 # # # # # 6 # # # # # 7 # # # # # L H Panic Value # # Unit mg/dl Calibration Type MB Formula Y=AX+B Counts # Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * * Point 3 * * Point 4 * * Point 5 * * Point 6 * * Point 7 * * 1-Point Cal. Point
MB Type Factor Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
URIC ACID (TOOS) FS
Order information Cat. No. Kit size 10 300 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3ml Std
1 3001 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml
10 300 023 R1 1 x 800 ml + R2 1 x 200 ml
10 300 030 6 x 3 ml standard
10 300 717 R1 5x 80 ml + R2 5 x 20 ml
Notes
1. Please refer to the package insert for Uric
Acid FS for the detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics concerning; Measuring Range Specificity/Interferences Sensitivity/Limit of Detection
Precision (Reproducibility, Repeatability)
Method Comparison Reference Ranges Literature 2. The stability of the reagent on board the
analyser is at least one month provided that contamination and evaporation are avoided
3. Manufactured by
DiaSys Diagnostic Systems GmbH & Co.KG Alte Strasse 9, 65558 Holzheim, Germany
February 2000/1
845 0950 10 02 21 September 2005/2
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name CO2 Type Serum Operation Yes
Sample Volume 3.0 µl Dilution 0 µl
Reagents R1 Volume 300 µl Dilution 0 µl
R2 Volume 0 µl Dilution 0 µl
Wavelength Pri 410 Sec 520
Method Endpoint
Reaction Slope +
Measuring point 1 First 1 Last 27
Measuring point 2 First Last
Linearity %
No-Lag-Time
Pre-dilution Rate
Min OD Max OD
Reagent OD Limit
First L -2.00 First H 2.50
Last L -2.00 Last H 2.50
Dynamic Range
L 0.0 H 50.0
Correlation Factor
A 1.000 B 0.000
On-board stability period #
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit mmol/l
Calibration Type AB Formula Y=AX+B Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2
Point 3 Point 4 Point 5 Point 6 Point 7
1-Point Cal. Point
MB Type Factor Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
BICARBONATE FS Order information Cat. No. 1 0950 .. .. …
Notes
1. Please refer to the package insert for Bicarbonate FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application proposal is for guidelines only. To avoid
misinterpretation measured results have to be validated and assessed with caution.
845 0950 10 02 21 September 2005/2
July 2001/3
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name CALC Type Serum Operation Yes
Sample Volume 2.0 µl Dilution 0 µl
Reagents R1 Volume 200 µl Dilution 0 µl
R2 Volume µl Dilution 0 µl
Wavelength Pri 660 Sec 700
Method END
Reaction Slope +
Measuring point 1 First 0 Last 27
Measuring point 2 First Last
Linearity %
No-Lag-Time
Pre-dilution Rate
Min OD Max OD
Reagent OD Limit
First L -0.100 First H 2.50
Last L -0.100 Last H 2.50
Dynamic Range
L 0.0 H 25.0
Correlation Factor
A 1 B 0
On-board stability period 30 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit mg/dl
Calibration Type AB Formula Y=AX+B Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * *
Point 3 * * Point 4 * * Point 5 * * Point 6 * * Point 7 * *
1-Point Cal. Point
MB Type Factor Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
CALCIUM AS FS Order information Cat. No. 1 1130 .. .. …
Notes
1. Please refer to the package insert for Calcium AS FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**Applications developed before December 2003 had been used at a variety of customer laboratories and are validated by use. Software upgrades at specific analysers may require further adjustments as they are out of our control
845 1130 10 02 21
December 2004/4
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name CKMB Type Serum Operation Yes
Sample Volume 7.0 µl Dilution 0 µl
Reagents R1 Volume 140 µl Dilution 0 µl
R2 Volume 35 µl Dilution 0 µl
Wavelength Pri 340 Sec 380
Method RATE
Reaction Slope +
Measuring point 1 First 20 Last 27
Measuring point 2 First Last
Linearity 15 %
No-Lag-Time No
Pre-dilution Rate
Min OD Max OD
0.000 2.50
Reagent OD Limit
First L 0.000 First H 2.50
Last L 0.000 Last H 2.50
Dynamic Range
L 0 H 700
Correlation Factor
A 1 B 0
On-board stability period 30 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit U/l
Calibration Type AB Formula Y=AX+B Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * *
Point 3 * * Point 4 * * Point 5 * * Point 6 * * Point 7 * *
1-Point Cal. Point
MB Type Factor Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
CK-MB FS Order information Cat. No. 1 1651 .. .. …
Notes
1. Please refer to the package insert for CK-MB FS for detailed
information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
845 1651 10 02 21
July 2001/3
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name CL Type Serum Operation Yes
Sample Volume 2.0 µl Dilution 0 µl
Reagents R1 Volume 200 µl Dilution 0 µl
R2 Volume µl Dilution 0 µl
Wavelength Pri 480 Sec 600
Method END
Reaction Slope +
Measuring point 1 First 0 Last 27
Measuring point 2 First Last
Linearity %
No-Lag-Time
Pre-dilution Rate
Min OD Max OD
Reagent OD Limit
First L -0.100 First H 2.50
Last L -0.100 Last H 2.50
Dynamic Range
L 0 H 140
Correlation Factor
A 1 B 0
On-board stability period 30 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit mmol/l
Calibration Type AB Formula Y=AX+B Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * *
Point 3 * * Point 4 * * Point 5 * * Point 6 * * Point 7 * *
1-Point Cal. Point
MB Type Factor Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
CHLORIDE FS Order information Cat. No. 1 1200 .. .. …
Notes
1. Please refer to the package insert for Chloride FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**Applications developed before December 2003 had been used at a variety of customer laboratories and are validated by use. Software upgrades at specific analysers may require further adjustments as they are out of our control
845 1200 10 02 21
July 2001/3
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name CHOL Type Serum Operation Yes
Sample Volume 2.0 µl Dilution 0 µl
Reagents R1 Volume 200 µl Dilution 0 µl
R2 Volume µl Dilution 0 µl
Wavelength Pri 520 Sec 700
Method END
Reaction Slope +
Measuring point 1 First 0 Last 27
Measuring point 2 First Last
Linearity %
No-Lag-Time
Pre-dilution Rate
Min OD Max OD
Reagent OD Limit
First L -0.100 First H 2.50
Last L -0.100 Last H 2.50
Dynamic Range
L 0 H 750
Correlation Factor
A 1 B 0
On-board stability period 30 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit mg/dl
Calibration Type AB Formula Y=AX+B Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * *
Point 3 * * Point 4 * * Point 5 * * Point 6 * * Point 7 * *
1-Point Cal. Point
MB Type Factor Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
CHOLESTEROL FS Order information Cat. No. 1 1300 .. .. …
Notes
1. Please refer to the package insert for Cholesterol FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**Applications developed before December 2003 had been used at a variety of customer laboratories and are validated by use. Software upgrades at specific analysers may require further adjustments as they are out of our control
845 1300 10 02 21
October 2004/1
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name CHE Type Serum Operation Yes
Sample Volume 3.0 µl Dilution 0 µl
Reagents R1 Volume 140 µl Dilution 0 µl
R2 Volume 35 µl Dilution 0 µl
Wavelength Pri 405 Sec 0
Method RATE
Reaction Slope -
Measuring point 1 First 13 Last 25
Measuring point 2 First Last
Linearity 15 %
No-Lag-Time No
Pre-dilution Rate
Min OD Max OD
-0.100 2.50
Reagent OD Limit
First L -0.100 First H 2.50
Last L -0.100 Last H 2.50
Dynamic Range
L 0 H 25000
Correlation Factor
A 1 B 0
On-board stability period 30 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit U/l
Calibration Type MB Formula Y=AX+B Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * *
Point 3 Point 4 Point 5 Point 6 Point 7
1-Point Cal. Point
MB Type Factor # Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
CHOLINESTERASE FS Order information Cat. No. 1 1401 .. .. …
Notes
1. Please refer to the package insert for Cholinesterase FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
845 1401 10 02 21
845 1711 10 02 21 July 2001/3
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name CREA Type Serum Operation Yes
Sample Volume 10.0 µl Dilution 0 µl
Reagents R1 Volume 140 µl Dilution 0 µl
R2 Volume 35 µl Dilution 0 µl
Wavelength Pri 520 Sec 800
Method FIXED
Reaction Slope +
Measuring point 1 First 13 Last 27
Measuring point 2 First Last
Linearity %
No-Lag-Time
Pre-dilution Rate
Min OD Max OD
-0.200 2.50
Reagent OD Limit
First L -0.200 First H 2.00
Last L -0.200 Last H 2.00
Dynamic Range
L 0.0 H 15.0
Correlation Factor
A 1 B 0
On-board stability period 30 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit mg/dl
Calibration Type AB Formula Y=AX+B Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * *
Point 3 * * Point 4 * * Point 5 * * Point 6 * * Point 7 * *
1-Point Cal. Point
MB Type Factor Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
CREATININE FS Order information Cat. No. 1 1711 .. .. …
Notes
1. Please refer to the package insert for Creatinine FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**Applications developed before December 2003 had been
used at a variety of customer laboratories and are validated by use. Software upgrades at specific analysers may require further adjustments as they are out of our control
845 1711 10 02 21 July 2001/3
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name CREA Type Serum Operation Yes
Sample Volume 10.0 µl Dilution 0 µl
Reagents R1 Volume 140 µl Dilution 0 µl
R2 Volume 35 µl Dilution 0 µl
Wavelength Pri 520 Sec 800
Method FIXED
Reaction Slope +
Measuring point 1 First 13 Last 27
Measuring point 2 First Last
Linearity %
No-Lag-Time
Pre-dilution Rate
Min OD Max OD
-0.200 2.50
Reagent OD Limit
First L -0.200 First H 2.00
Last L -0.200 Last H 2.00
Dynamic Range
L 0.0 H 15.0
Correlation Factor
A 1 B -0.3
On-board stability period 30 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit mg/dl
Calibration Type AB Formula Y=AX+B Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * *
Point 3 * * Point 4 * * Point 5 * * Point 6 * * Point 7 * *
1-Point Cal. Point
MB Type Factor Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
CREATININE FS
Compensated Method To use the Creatinine FS Compensated Method on the Olympus AU 400 and AU 640 the Correlation factor ’B’ must be changed as follows; When the units are mg/dL
Correlation Factor B = - 0.3
When the units are µmol/L
Correlation Factor B = - 27
Note: Ensure that when using the Creatinine Compensated Method the relevant assigned Calibrator value is selected
September 2005/1
OLYMPUS AU 400/640 Specific Test Parameters General Test Name CREA Type Serum Operation Yes
Sample Volume 4.0 µl Dilution 0 µl
Reagents R1 Volume 160 µl Dilution 0 µl
R2 Volume 80 µl Dilution 0 µl
Wavelength Pri 540 Sec 660 Method END Reaction Slope + Measuring point 1 First 0 Last 27 Measuring point 2 First 0 Last 10 Linearity % No-Lag-Time Pre-dilution Rate Min OD Max OD Reagent OD Limit First L -0.100 First H 2.00 Last L -0.100 Last H 2.00 Dynamic Range
L 0.0 H 30.0 Correlation Factor
A 1 B 0 On-board stability period 30 Days Value/Flag # Level L # Level H # Normal Ranges Age L Age H Sex Year Month Year Month 1 # # # # # 2 # # # # # 3 # # # # # 4 # # # # # 5 # # # # # 6 # # # # # 7 # # # # #
L H Panic Value # # Unit mg/dl Calibration Type AB Formula Y=AX+B Counts # Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * * Point 3 * * Point 4 * * Point 5 * * Point 6 * * Point 7 * * 1-Point Cal. Point MB Type Factor Calibration Stability Period #) Data entry by the user *) Enter calibration or standard value and position
CREATININE PAP FS
Cat. No. 1 1759.... Notes 1. Please refer to the package insert for Creatinine PAP FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
845 1759 10 02 21
845 7059 10 02 21 September 2006/4
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name FER Type Serum Operation Yes
Sample Volume 5.0 µl Dilution 0 µl
Reagents R1 Volume 100 µl Dilution 0 µl
R2 Volume 50 µl Dilution 0 µl
Wavelength Pri 570 Sec
Method FIXED
Reaction Slope +
Measuring point 1 First 11 Last 24
Measuring point 2 First Last
Linearity %
No-Lag-Time
Pre-dilution Rate
Min OD Max OD
Reagent OD Limit
First L -0.100 First H 2.50
Last L -0.100 Last H 2.50
Dynamic Range
L 5 H 1000
Correlation Factor
A 1 B 0
On-board stability period 30 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit µg/l
Calibration Type
5AB Formula POLYGONAL Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 NaCl 0 Point 2 100 *
Point 3 200 * Point 4 500 * Point 5 1000 * Point 6 Point 7
1-Point Cal. Point
MB Type Factor Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
FERRITIN FS Order information Cat. No. 1 7059 .. .. …
Notes
1. Please refer to the package insert for Ferritin FS for
detailed information about the test on the following
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding - Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
845 2801 10 02 21 July 2001/3
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name GGT Type Serum Operation Yes
Sample Volume 4.o µl Dilution 0 µl
Reagents R1 Volume 140 µl Dilution 0 µl
R2 Volume 35 µl Dilution 0 µl
Wavelength Pri 420 Sec 700
Method RATE
Reaction Slope +
Measuring point 1 First 13 Last 25
Measuring point 2 First Last
Linearity 15 %
No-Lag-Time No
Pre-dilution Rate
Min OD Max OD
-0.100 2.50
Reagent OD Limit
First L -0.100 First H 2.50
Last L -0.100 Last H 2.50
Dynamic Range
L 0 H 300
Correlation Factor
A 1 B 0
On-board stability period 30 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit U/l
Calibration Type MB Formula Y=AX+B Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * *
Point 3 * * Point 4 * * Point 5 * * Point 6 * * Point 7 * *
1-Point Cal. Point
MB Type Factor Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
GAMMA GT FS (Szasz mod.) Order information Cat. No. 1 2801 .. .. …
Notes
1. Please refer to the package insert for Gamma-GT FS (Szasz mod.)
for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**Applications developed before December 2003 had been
used at a variety of customer laboratories and are validated by use. Software upgrades at specific analysers may require further adjustments as they are out of our control
845 2500 10 02 21 July 2001/3
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name GLUC Type Serum Operation Yes
Sample Volume 2.0 µl Dilution 0 µl
Reagents R1 Volume 200 µl Dilution 0 µl
R2 Volume µl Dilution 0 µl
Wavelength Pri 520 Sec 700
Method END
Reaction Slope +
Measuring point 1 First 0 Last 27
Measuring point 2 First Last
Linearity %
No-Lag-Time
Pre-dilution Rate
Min OD Max OD
Reagent OD Limit
First L -0.100 First H 2.50
Last L -0.100 Last H 2.50
Dynamic Range
L 0 H 400
Correlation Factor
A 1 B 0
On-board stability period 30 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit mg/dl
Calibration Type AB Formula Y=AX+B Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * *
Point 3 * * Point 4 * * Point 5 * * Point 6 * * Point 7 * *
1-Point Cal. Point
MB Type Factor Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
GLUCOSE GOD FS Order information Cat. No. 1 2500 .. .. …
Notes
1. Please refer to the package insert for Glucose GODFS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**Applications developed before December 2003 had been
used at a variety of customer laboratories and are validated by use. Software upgrades at specific analysers may require further adjustments as they are out of our control
845 2500 10 02 21 July 2001/3
May 2010/7
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name HbA1c Type Sample Operation Yes
Sample Volume 4.0 µl Dilution 0 µl
Reagents R1 Volume 150 µl Dilution 0 µl
R2 Volume 75 µl Dilution 0 µl
Wavelength Pri 660 Sec 0
Method END
Reaction Slope +
Measuring point 1 First 0 Last 27
Measuring point 2 First Last
Linearity %
No-Lag-Time
Pre-dilution Rate
Min OD Max OD
-2.000 2.500
Reagent OD Limit
First L -0.100 First H 2.500
Last L -0.100 Last H 2.500
Dynamic Range
L # H #
Correlation Factor
A 1 B 0
On-board stability period 30 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit #
Calibration Type 5AB Formula SPLINE Counts 2
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * * Point 3 * *
Point 4 * * Point 5 * * Point 6 Point 7
1-Point Cal. Point
MB Type Factor Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
oneHbA1c FS Hemolysate application
Order information Cat. No. 1 3329 .. …
Notes
1. Please refer to the package insert for oneHbA1c FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
845 3329 10 02 21
May 2005/2
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name LAC Type Serum Operation Yes
Sample Volume 2.5 µl Dilution 0 µl
Reagents R1 Volume 160 µl Dilution 0 µl
R2 Volume 40 µl Dilution 0 µl
Wavelength Pri 340 Sec 800
Method END
Reaction Slope +
Measuring point 1 First 0 Last 27
Measuring point 2 First 0 Last 10
Linearity %
No-Lag-Time
Pre-dilution Rate
Min OD Max OD
Reagent OD Limit
First L -0.100 First H 2.50
Last L -0.100 Last H 2.50
Dynamic Range
L 1 H 120
Correlation Factor
A 1 B 0
On-board stability period 30 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit mg/dl
Calibration Type AB Formula Y=AX+B Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * * Point 3 * *
Point 4 * * Point 5 * * Point 6 * * Point 7 * *
1-Point Cal. Point
MB Type Factor Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
LACTATE FS Order information Cat. No. 1 4001 .. .. …
Notes
1. Please refer to the package insert for Lactate FS for detailed
information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
845 4001 10 02 21
845 4201 10 02 21 May 2010/4
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name LDH Type Serum Operation Yes
Sample Volume 3.5 µl Dilution 0 µl
Reagents R1 Volume 140 µl Dilution 0 µl
R2 Volume 35 µl Dilution 0 µl
Wavelength Pri 340 Sec 380
Method RATE
Reaction Slope -
Measuring point 1 First 13 Last 23
Measuring point 2 First Last
Linearity 15 %
No-Lag-Time No
Pre-dilution Rate
Min OD Max OD
0.000 2.50
Reagent OD Limit
First L 0.000 First H 2.50
Last L 0.000 Last H 2.50
Dynamic Range
L 0 H 1500
Correlation Factor
A 1 B 0
On-board stability period 30 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit U/l
Calibration Type AB Formula Y=AX+B Counts #
Factor Factor Cal.No OD CONC OD-L OD-H
Point 1 * *
Point 2 * *
Point 3 * *
Point 4 * *
Point 5 * *
Point 6 * *
Point 7 * *
1-Point Cal. Point
MB Type Factor 10282 Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
LDH DGKC FS Order information Cat. No. 1 4201 .. .. …
Notes
1. Please refer to the package insert for LDH DGKC FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**Applications developed before December 2003 had been used at a variety of customer laboratories and are validated by use. Software upgrades at specific analysers may require further adjustments as they are out of our control
845 4121 10 02 21 December 2004/2
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name LDL Type Serum Operation Yes
Sample Volume 2.0 µl Dilution 0 µl
Reagents R1 Volume 186 µl Dilution 0 µl
R2 Volume 47 µl Dilution 0 µl
Wavelength Pri 600 Sec 700
Method END
Reaction Slope +
Measuring point 1 First 0 Last 27
Measuring point 2 First 0 Last 10
Linearity %
No-Lag-Time
Pre-dilution Rate
Min OD Max OD
0.000 2.50
Reagent OD Limit
First L -0.100 First H 2.50
Last L -0.100 Last H 2.50
Dynamic Range
L 0 H 400
Correlation Factor
A 1 B 0
On-board stability period 30 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit mg/dl
Calibration Type AB Formula Y=AX+B Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * *
Point 3 * * Point 4 * * Point 5 * * Point 6 * * Point 7 * *
1-Point Cal. Point
MB Type Factor Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
LDL-C SELECT FS Order information Cat. No. 1 4121 .. .. …
Notes
1. Please refer to the package insert for LDL-C Select FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
845 4321 10 02 26 October 2007/2
OLYMPUS AU 600 Specific Test Parameters – Reagent ID: 030 General
Test Name LIP Type Serum Operation Yes
Sample Volume 3.0 µl Dilution 0 µl
Reagents R1 Volume 140 µl Dilution 0 µl
R2 Volume 35 µl Dilution 0 µl
Wavelength Pri 570 Sec 700
Method RATE
Reaction Slope +
Measuring point 1 First 14 Last 23
Measuring point 2 First Last
Linearity 15 %
No-Lag-Time Yes
Pre-dilution Rate 1
Min OD Max OD
-0.100 2.50
Reagent OD Limit
First L -0.100 First H 2.50
Last L -0.100 Last H 2.50
Dynamic Range
L 3 H 300
Correlation Factor
A 1.000 B 0.000
On-board stability period 21 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit U/l
Calibration Type AB Formula Y=AX+B Counts #
Factor Factor Cal.No OD CONC OD-L OD-H
Point 1 * * Point 2 Point 3 Point 4 Point 5 Point 6
Point 7
1-Point Cal. Point
MB Type Factor Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
LIPASE DC FS Order information Cat. No. 1 4321 .. .. …
Notes
1. Please refer to the package insert for Lipase DC FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at
least 40 days provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 4321 10 02 26 October 2007/2
OLYMPUS AU 400/640 Specific Test Parameters – Reagent ID: 030 General
Test Name LIP Type Serum Operation Yes
Sample Volume 2.5 µl Dilution 0 µl
Reagents R1 Volume 120 µl Dilution 0 µl
R2 Volume 30 µl Dilution 0 µl
Wavelength Pri 570 Sec 700
Method RATE
Reaction Slope +
Measuring point 1 First 14 Last 23
Measuring point 2 First Last
Linearity 15 %
No-Lag-Time Yes
Pre-dilution Rate 1
Min OD Max OD
-0.100 2.50
Reagent OD Limit
First L -0.100 First H 2.50
Last L -0.100 Last H 2.50
Dynamic Range
L 3 H 300
Correlation Factor
A 1.000 B 0.000
On-board stability period 21 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit U/l
Calibration Type AB Formula Y=AX+B Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 Point 3 Point 4 Point 5 Point 6
Point 7
1-Point Cal. Point
MB Type Factor Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
OLYMPUS AU 2700/5400 Specific Test Parameters – Reagent ID: 030 General
Test Name LIP Type Serum Operation Yes
Sample Volume 2.5 µl Dilution 0 µl
Reagents R1 Volume 120 µl Dilution 0 µl
R2 Volume 30 µl Dilution 0 µl
Wavelength Pri 570 Sec 700
Method RATE
Reaction Slope +
Measuring point 1 First 14 Last 23
Measuring point 2 First Last
Linearity 15 %
No-Lag-Time Yes
Pre-dilution Rate 1
Min OD Max OD
-0.100 2.50
Reagent OD Limit
First L -0.100 First H 2.50
Last L -0.100 Last H 2.50
Dynamic Range
L 3 H 300
Correlation Factor
A 1.000 B 0.000
On-board stability period 21 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit U/l
Calibration Type AB Formula Y=AX+B Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 Point 3 Point 4 Point 5 Point 6
Point 7
1-Point Cal. Point
MB Type Factor Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
845 7139 10 02 21 October 2007/3
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name LPA Type Serum Operation Yes
Sample Volume 4.0 µl Dilution 0 µl
Reagents R1 Volume 160 µl Dilution 0 µl
R2 Volume 80 µl Dilution 0 µl
Wavelength Pri 700 Sec 0
Method FIXED
Reaction Slope +
Measuring point 1 First 13 Last 27
Measuring point 2 First 0 Last 0
Linearity %
No-Lag-Time
Pre-dilution Rate
Min OD Max OD
Reagent OD Limit
First L -2.000 First H 2.50
Last L -2.000 Last H 2.50
Dynamic Range
L 3 H 120
Correlation Factor
A 1 B 0
On-board stability period 30 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit mg/dl
Calibration Type 5AB Formula POLYGONAL Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * 0.0 Point 2 * *
Point 3 * * Point 4 * * Point 5 * * Point 6 * * Point 7
1-Point Cal. Point
MB Type Factor Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
Lp(a) 21 FS Order information Cat. No. 1 7139 .. .. …
Notes
1. Please refer to the package insert for Lp (a) 21 FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application proposal is for guidelines only. To avoid
misinterpretation measured results have to be validated and assessed with caution.
845 4610 10 02 21 July 2001/3
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name MG Type Serum Operation Yes
Sample Volume 2.0 µl Dilution 0 µl
Reagents R1 Volume 200 µl Dilution 0 µl
R2 Volume µl Dilution 0 µl
Wavelength Pri 540 Sec 700
Method END
Reaction Slope +
Measuring point 1 First 0 Last 27
Measuring point 2 First Last
Linearity %
No-Lag-Time
Pre-dilution Rate
Min OD Max OD
Reagent OD Limit
First L 0.200 First H 2.50
Last L 0.200 Last H 2.50
Dynamic Range
L 0 H 5.0
Correlation Factor
A 1 B 0
On-board stability period 30 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit mg/dl
Calibration Type AB Formula Y=AX+B Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * *
Point 3 * * Point 4 * * Point 5 * * Point 6 * * Point 7 * *
1-Point Cal. Point
MB Type Factor Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
MAGNESIUM XL FS Order information Cat. No. 1 4610 .. .. …
Notes
1. Please refer to the package insert for Magnesium XL FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**Applications developed before December 2003 had been used at a variety of customer laboratories and are validated by use. Software upgrades at specific analysers may require further adjustments as they are out of our control
845 7045 10 92 21 February 2006/2
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name CRPs Type Serum Operation Yes
Sample Volume 15.0 µl Dilution 0 µl
Reagents R1 Volume 150 µl Dilution 0 µl
R2 Volume 150 µl Dilution 0 µl
Wavelength Pri 520 Sec 800
Method FIXED
Reaction Slope +
Measuring point 1 First 14 Last 27
Measuring point 2 First 0 Last 0
Linearity %
No-Lag-Time
Pre-dilution Rate
Min OD Max OD
Reagent OD Limit
First L -0.100 First H 2.50
Last L -0.100 Last H 2.50
Dynamic Range
L 0.05 H 20.0
Correlation Factor
A 1 B 0
On-board stability period 30 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit mg/l
CalType 5AB Formula SPLINE Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * *
Point 3 * * Point 4 * * Point 5 * * Point 6 Point 7
1-Point Cal. Point
MB Type Factor Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
CRP U-hs High sensitive (hs) application
Order information Cat. No. 1 7045 .. .. …
Notes
1. Please refer to the package insert for CRP U-hs FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
845 7045 10 02 21 February 2006/2
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name CRPU Type Serum Operation Yes
Sample Volume 3.0 µl Dilution 0 µl
Reagents R1 Volume 150 µl Dilution 0 µl
R2 Volume 150 µl Dilution 0 µl
Wavelength Pri 520 Sec 800
Method FIXED
Reaction Slope +
Measuring point 1 First 14 Last 27
Measuring point 2 First 0 Last 0
Linearity %
No-Lag-Time
Pre-dilution Rate
Min OD Max OD
Reagent OD Limit
First L -0.100 First H 2.50
Last L -0.100 Last H 2.50
Dynamic Range
L 0.3 H 350.0
Correlation Factor
A 1 B 0
On-board stability period 30 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit mg/l
CalType 5AB Formula SPLINE Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * *
Point 3 * * Point 4 * * Point 5 * * Point 6 Point 7
1-Point Cal. Point
MB Type Factor Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
CRP U-hs Universal (U) application
Order information Cat. No. 1 7045 .. .. …
Notes
1. Please refer to the package insert for CRP U-hs FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
845 2311 10 02 21 July 2001/3
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name TP Type Serum Operation Yes
Sample Volume 4.0 µl Dilution 0 µl
Reagents R1 Volume 160 µl Dilution 0 µl
R2 Volume 40 µl Dilution 0 µl
Wavelength Pri 540 Sec 700
Method END
Reaction Slope +
Measuring point 1 First 0 Last 27
Measuring point 2 First 0 Last 10
Linearity %
No-Lag-Time
Pre-dilution Rate
Min OD Max OD
Reagent OD Limit
First L -0.100 First H 2.50
Last L -0.100 Last H 2.50
Dynamic Range
L 0.0 H 15.0
Correlation Factor
A 1 B 0
On-board stability period 30 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit g/dl
Calibration Type AB Formula Y=AX+B Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * *
Point 3 * * Point 4 * * Point 5 * * Point 6 * * Point 7 * *
1-Point Cal. Point
MB Type Factor Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
TOTAL PROTEIN FS Order information Cat. No. 1 2311 .. .. …
Notes
1. Please refer to the package insert for Total Protein FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**Applications developed before December 2003 had been
used at a variety of customer laboratories and are validated by use. Software upgrades at specific analysers may require further adjustments as they are out of our control
845 0210 10 02 21 Dec 2002/1
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name TPU Type Serum Operation Yes
Sample Volume 4.0 µl Dilution 0 µl
Reagents R1 Volume 200 µl Dilution 0 µl
R2 Volume µl Dilution 0 µl
Wavelength Pri 600 Sec 700
Method END
Reaction Slope +
Measuring point 1 First 0 Last 27
Measuring point 2 First Last
Linearity %
No-Lag-Time
Pre-dilution Rate
Min OD Max OD
Reagent OD Limit
First L -0.100 First H 2.50
Last L -0.100 Last H 2.50
Dynamic Range
L 0 H 3000
Correlation Factor
A 1 B 0
On-board stability period 30 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit mg/l
Calibration Type AB Formula Y=AX+B Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * *
Point 3 * * Point 4 * * Point 5 * * Point 6 * * Point 7 * *
1-Point Cal. Point
MB Type Factor Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
TOTAL PROTEIN UC FS Order information Cat. No. 1 0210 .. .. …
Notes
1. Please refer to the package insert for Total Protein UC FS
for detailed information about the test on the following
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
July 2001/3
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name GOT Type Serum Operation Yes
Sample Volume 10.0 µl Dilution 0 µl
Reagents R1 Volume 140 µl Dilution 0 µl
R2 Volume 35 µl Dilution 0 µl
Wavelength Pri 340 Sec 380
Method RATE
Reaction Slope -
Measuring point 1 First 13 Last 25
Measuring point 2 First Last
Linearity 15 %
No-Lag-Time No
Pre-dilution Rate
Min OD Max OD
0.000 2.50
Reagent OD Limit
First L 0.000 First H 2.50
Last L 0.000 Last H 2.50
Dynamic Range
L 0 H 600
Correlation Factor
A 1 B 0
On-board stability period 30 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit U/l
Calibration Type MB Formula Y=AX+B Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * *
Point 3 * * Point 4 * * Point 5 * * Point 6 * * Point 7 * *
1-Point Cal. Point
MB Type Factor 3730 Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
ASAT(GOT) FS (IFCC Mod) Order information Cat. No. 1 2601 .. .. …
Notes
1. Please refer to the package insert for ASAT(GOT) FS (IFCC Mod)
for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**Applications developed before December 2003 had been
used at a variety of customer laboratories and are validated by use. Software upgrades at specific analysers may require further adjustments as they are out of our control
845 2601 10 02 21
July 2001/3
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name GPT Type Serum Operation Yes
Sample Volume 10.0 µl Dilution 0 µl
Reagents R1 Volume 140 µl Dilution 0 µl
R2 Volume 35 µl Dilution 0 µl
Wavelength Pri 340 Sec 380
Method RATE
Reaction Slope -
Measuring point 1 First 13 Last 25
Measuring point 2 First Last
Linearity 15 %
No-Lag-Time No
Pre-dilution Rate
Min OD Max OD
0.000 2.50
Reagent OD Limit
First L 0.000 First H 2.50
Last L 0.000 Last H 2.50
Dynamic Range
L 0 H 600
Correlation Factor
A 1 B 0
On-board stability period 30 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit U/l
Calibration Type MB Formula Y=AX+B Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * *
Point 3 * * Point 4 * * Point 5 * * Point 6 * * Point 7 * *
1-Point Cal. Point
MB Type Factor 3730 Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
ALAT(GPT) FS (IFCC Mod.) Order information Cat. No. 1 2701 .. .. …
Notes
1. Please refer to the package insert for ALAT(GPT) FS (IFCC Mod.)
for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**Applications developed before December 2003 had been
used at a variety of customer laboratories and are validated by use. Software upgrades at specific analysers may require further adjustments as they are out of our control
845 2701 10 02 21
845 5710 10 02 21 July 2001/3
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name TRIG Type Serum Operation Yes
Sample Volume 2.0 µl Dilution 0 µl
Reagents R1 Volume 200 µl Dilution 0 µl
R2 Volume µl Dilution 0 µl
Wavelength Pri 520 Sec 700
Method END
Reaction Slope +
Measuring point 1 First 0 Last 27
Measuring point 2 First Last
Linearity %
No-Lag-Time
Pre-dilution Rate
Min OD Max OD
Reagent OD Limit
First L -0.100 First H 2.50
Last L -0.100 Last H 2.50
Dynamic Range
L 0 H 1000
Correlation Factor
A 1 B 0
On-board stability period 30 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit mg/dl
Calibration Type AB Formula Y=AX+B Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * *
Point 3 * * Point 4 * * Point 5 * * Point 6 * * Point 7 * *
1-Point Cal. Point
MB Type Factor Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
TRIGLYCERIDES FS Order information Cat. No. 1 5710 .. .. …
Notes
1. Please refer to the package insert for Triglycerides FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**Applications developed before December 2003 had been
used at a variety of customer laboratories and are validated by use. Software upgrades at specific analysers may require further adjustments as they are out of our control
845 5710 10 02 21 July 2001/3
845 3101 10 02 21 July 2001/3
OLYMPUS AU 400/640 Specific Test Parameters General
Test Name UREA Type Serum Operation Yes
Sample Volume 2.0 µl Dilution 0 µl
Reagents R1 Volume 140 µl Dilution 0 µl
R2 Volume 35 µl Dilution 0 µl
Wavelength Pri 340 Sec 380
Method RATE
Reaction Slope -
Measuring point 1 First 12 Last 16
Measuring point 2 First Last
Linearity 30 %
No-Lag-Time No
Pre-dilution Rate
Min OD Max OD
0.000 2.50
Reagent OD Limit
First L 0.000 First H 2.50
Last L 0.000 Last H 2.50
Dynamic Range
L 0 H 300
Correlation Factor
A 1 B 0
On-board stability period 30 Days
Value/Flag # Level L # Level H #
Normal Ranges Age L Age H Sex Year Month Year Month
1 # # # # #
2 # # # # #
3 # # # # #
4 # # # # #
5 # # # # #
6 # # # # #
7 # # # # #
L H
Panic Value # # Unit md/dl
Calibration Type MB Formula Y=AX+B Counts #
Factor Factor Cal.No OD CONC OD-L OD-H Point 1 * * Point 2 * *
Point 3 * * Point 4 * * Point 5 * * Point 6 * * Point 7 * *
1-Point Cal. Point
MB Type Factor Calibration Stability Period
#) Data entry by the user *) Enter calibration or standard value and position
UREA FS Order information Cat. No. 1 3101 .. .. …
Notes
1. Please refer to the package insert for Urea FS for detailed
information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**Applications developed before December 2003 had been used at a variety of customer laboratories and are validated by use. Software upgrades at specific analysers may require further adjustments as they are out of our control