olympus au 600 - asterisco...olympus au 2700/5400 specific test parameters – reagent id: 004...

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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.

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Page 1: OLYMPUS AU 600 - Asterisco...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

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.

Page 2: OLYMPUS AU 600 - Asterisco...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

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

Page 3: OLYMPUS AU 600 - Asterisco...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

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

Page 4: OLYMPUS AU 600 - Asterisco...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

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

Page 5: OLYMPUS AU 600 - Asterisco...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

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

Page 6: OLYMPUS AU 600 - Asterisco...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

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

Page 7: OLYMPUS AU 600 - Asterisco...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

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

Page 8: OLYMPUS AU 600 - Asterisco...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

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

Page 9: OLYMPUS AU 600 - Asterisco...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

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

Page 10: OLYMPUS AU 600 - Asterisco...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

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.

Page 11: OLYMPUS AU 600 - Asterisco...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

845 0950 10 02 21 September 2005/2

Page 12: OLYMPUS AU 600 - Asterisco...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

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

Page 13: OLYMPUS AU 600 - Asterisco...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

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

Page 14: OLYMPUS AU 600 - Asterisco...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

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

Page 15: OLYMPUS AU 600 - Asterisco...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

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

Page 16: OLYMPUS AU 600 - Asterisco...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

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

Page 17: OLYMPUS AU 600 - Asterisco...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

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

Page 18: OLYMPUS AU 600 - Asterisco...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

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

Page 19: OLYMPUS AU 600 - Asterisco...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

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

Page 20: OLYMPUS AU 600 - Asterisco...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

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.

Page 21: OLYMPUS AU 600 - Asterisco...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

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

Page 22: OLYMPUS AU 600 - Asterisco...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

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

Page 23: OLYMPUS AU 600 - Asterisco...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

845 2500 10 02 21 July 2001/3

Page 24: OLYMPUS AU 600 - Asterisco...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

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

Page 25: OLYMPUS AU 600 - Asterisco...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

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

Page 26: OLYMPUS AU 600 - Asterisco...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

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

Page 27: OLYMPUS AU 600 - Asterisco...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

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.

Page 28: OLYMPUS AU 600 - Asterisco...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

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.

Page 29: OLYMPUS AU 600 - Asterisco...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

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

Page 30: OLYMPUS AU 600 - Asterisco...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

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.

Page 31: OLYMPUS AU 600 - Asterisco...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

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

Page 32: OLYMPUS AU 600 - Asterisco...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

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

Page 33: OLYMPUS AU 600 - Asterisco...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

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

Page 34: OLYMPUS AU 600 - Asterisco...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

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

Page 35: OLYMPUS AU 600 - Asterisco...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

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

Page 36: OLYMPUS AU 600 - Asterisco...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

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

Page 37: OLYMPUS AU 600 - Asterisco...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

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

Page 38: OLYMPUS AU 600 - Asterisco...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

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

Page 39: OLYMPUS AU 600 - Asterisco...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

845 5710 10 02 21 July 2001/3

Page 40: OLYMPUS AU 600 - Asterisco...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

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