au 5200 alat - kovalent€¦ · test parameters item code gpt function select no. 1. operation yes...

21
OLYMPUS AU 5200 Chemistry setting Temperature : 37°C Test parameters Item code GPT Function select No. 1. Operation Yes 2. Sample volume 15 3. Sample volume at repeat run 4 4. Reagent volume R1 200 Reagent volume R2 50 5. W 3 parameter Prime (bottle to valve) R1 Yes Prime (bottle to valve) R2 Yes Dispense level (valve to cuvette) R 1 100 Dispense level (valve to cuvette) R 2 100 6 Method Rate 7 Wavelength 1 340 Wavelength 2 380 8 Reaction slop - 9 Measuring point start 9 Measuring point end 16 10 O.D. value range max 2.000 O.D. value range min 0.000 11 Limit of Linearity % 15 12 Normal value H 37 Normal value L 0 13 Dynamic range H 800 Dynamic range L 0 14 Panic value H # Panic value L # 15 Reagent OD range First Point H 2.000 First Point L -2.000 Last Point H 2.000 Last Point L -2.000 16 Decision level for repeat run H 9999 Decision level for repeat run L 0.0 17 R. dispence by black rack 0 18 R. dispence by black interval 0 Calibration parameters Calibration type MB ODO Conc. 0.000 Cal. No. {x}> # Conc. > # Factor range H Factor range L Factor **3865 Correlation correction Correlation coefficient A Correlation coefficient B #) Data entry by the user *) Calculated by the analyzer **) Factor must be checked by calibration serum ALAT(GPT) FS (IFCC Mod.) Order information Cat. No. Kit size 10 270 021 R1 5 x 20 ml + R2 1 x 25 ml 10 270 022 R1 5 x 80 ml + R2 1 x 100 ml 10 270 023 R1 1 x 800 ml + R2 1 x 200 ml For determination with pyridoxal-5-phosphate activation additionally required: 10 501 030 6 x 3 ml Notes 1. Please refer to the package insert for ALAT(GPT) FS (IFCC Mod.) 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.

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Page 1: AU 5200 ALAT - Kovalent€¦ · Test parameters Item code GPT Function select No. 1. Operation Yes 2. Sample volume 15 3. Sample volume at repeat run 4 4. Reagent volume R1 200 Reagent

OLYMPUS AU 5200

Chemistry setting

Temperature : 37°C

Test parameters

Item code GPT

Function select No.

1. Operation Yes

2. Sample volume 15

3. Sample volume at repeat run 4

4. Reagent volume R1 200

Reagent volume R2 50

5. W 3 parameter

Prime (bottle to valve) R1 Yes

Prime (bottle to valve) R2 Yes

Dispense level (valve to

cuvette) R 1

100

Dispense level (valve to

cuvette) R 2

100

6 Method Rate

7 Wavelength 1 340

Wavelength 2 380

8 Reaction slop -

9 Measuring point start 9

Measuring point end 16

10 O.D. value range max 2.000

O.D. value range min 0.000

11 Limit of Linearity % 15

12 Normal value H 37

Normal value L 0

13 Dynamic range H 800

Dynamic range L 0

14 Panic value H #

Panic value L #

15 Reagent OD range

First Point H 2.000

First Point L -2.000

Last Point H 2.000

Last Point L -2.000

16 Decision level for repeat

run H

9999

Decision level for repeat

run L

0.0

17 R. dispence by black rack 0

18 R. dispence by black

interval

0

Calibration parameters

Calibration type MB

ODO – Conc. 0.000

Cal. No. {x}> #

Conc. > #

Factor range H

Factor range L

Factor **3865

Correlation correction

Correlation coefficient A

Correlation coefficient B

#) Data entry by the user

*) Calculated by the analyzer

**) Factor must be checked by calibration

serum

ALAT(GPT) FS (IFCC Mod.)

Order information

Cat. No. Kit size

10 270 021 R1 5 x 20 ml + R2 1 x 25 ml

10 270 022 R1 5 x 80 ml + R2 1 x 100 ml

10 270 023 R1 1 x 800 ml + R2 1 x 200 ml

For determination with pyridoxal-5-phosphate

activation additionally required:

10 501 030 6 x 3 ml

Notes

1. Please refer to the package insert for

ALAT(GPT) FS (IFCC Mod.) 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.

Page 2: AU 5200 ALAT - Kovalent€¦ · Test parameters Item code GPT Function select No. 1. Operation Yes 2. Sample volume 15 3. Sample volume at repeat run 4 4. Reagent volume R1 200 Reagent

OLYMPUS AU 5200

Chemistry setting

Temperature : 37°C

Test parameters

Item code ALP

Function select No.

1. Operation Yes

2. Sample volume 4

3. Sample volume at repeat run 2

4. Reagent volume R1 200

Reagent volume R2 50

5. W 3 parameter

Prime (bottle to valve) R1 Yes

Prime (bottle to valve) R2 Yes

Dispense level (valve to

cuvette) R 1

100

Dispense level (valve to

cuvette) R 2

100

6 Method Rate

7 Wavelength 1 410

Wavelength 2 660+

8 Reaction slop +

9 Measuring point start 10

Measuring point end 15

10 O.D. value range max 2.000

O.D. value range min 0.000

11 Limit of Linearity % 15

12 Normal value H 141

Normal value L 28

13 Dynamic range H 850

Dynamic range L 0

14 Panic value H #

Panic value L #

15 Reagent OD range

First Point H 2.000

First Point L -2.000

Last Point H 2.000

Last Point L -2.000

16 Decision level for repeat

run H

9999

Decision level for repeat

run L

0.0

17 R. dispence by black rack 0

18 R. dispence by black

interval

0

Calibration parameters

Calibration type AB

ODO – Conc. 0.000

Cal. No. {x}> #

Conc. > #

Factor range H

Factor range L

Factor *

Correlation correction

Correlation coefficient A

Correlation coefficient B

#) Data entry by the user

*) Calculated by the analyzer

ALKALINE PHOSPHATASE FS IFCC

Order information

Cat. No. Kit size

10 041 021 R1 5x 20 ml + R2 1x 25 ml

10 041 022 R1 5x 80 ml + R2 1x 100 ml

10 041 023 R1 1x 800 ml + R2 1x 200 ml

Notes

1. Please refer to the package insert for

Alkaline phosphatase FS IFCC 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 of 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.

Page 3: AU 5200 ALAT - Kovalent€¦ · Test parameters Item code GPT Function select No. 1. Operation Yes 2. Sample volume 15 3. Sample volume at repeat run 4 4. Reagent volume R1 200 Reagent

OLYMPUS AU 5200

Chemistry setting Temperature : 37°C

Test parameters

Item code AMY

Function select No.

1. Operation Yes 2. Sample volume 3

3. Sample volume at repeat run 2 4. Reagent volume R1 200 Reagent volume R2 50 5. W 3 parameter

Prime (bottle to valve) R1 Yes Prime (bottle to valve) R2 Yes Dispense level (valve to cuvette) R 1 100 Dispense level (valve to cuvette) R 2 100

6 Method Rate 7 Wavelength 1 410 Wavelength 2 660 8 Reaction slop +

9 Measuring point start 10 Measuring point end 15 10 O.D. value range max 2.000 O.D. value range min 0.000

11 Limit of Linearity % 15 12 Normal value H 100 Normal value L 0 13 Dynamic range H 2000

Dynamic range L 0 14 Panic value H # Panic value L # 15 Reagent OD range

First Point H 2.000 First Point L -2.000 Last Point H 2.000 Last Point L -2.000

16 Decision level for repeat run H 9999 Decision level for repeat run L 0.0 17 R. dispence by black rack 0

18 R. dispence by black interval 0

Calibration parameters

Calibration type AB ODO – Conc. 0.000 Cal. No. {x}> #

Conc. > # Factor range H Factor range L Factor *

Correlation correction

Correlation coefficient A Correlation coefficient B

#) Data entry by the user

*) Calculated by the analyzer

-AMYLASE CC FS

Order information Cat. No. Kit size

10 050 021 R1 5 x 20 ml + R2 1 x 25 ml

10 050 022 R1 5 x 80 ml + R2 1 x 100 ml

10 050 023 R1 1 x 800 ml + R2 1 x 200 ml

10 050 717 R1 5x 80 ml + R2 5 x 20 ml

Notes

1. Please refer to the package insert for -Amylase CC

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 of 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.

Page 4: AU 5200 ALAT - Kovalent€¦ · Test parameters Item code GPT Function select No. 1. Operation Yes 2. Sample volume 15 3. Sample volume at repeat run 4 4. Reagent volume R1 200 Reagent

OLYMPUS AU 5200

Chemistry setting

Temperature : 37°C

Test parameters

Item code GOT

Function select No.

1. Operation Yes

2. Sample volume 15

3. Sample volume at repeat run 4

4. Reagent volume R1 200

Reagent volume R2 50

5. W 3 parameter

Prime (bottle to valve) R1 Yes

Prime (bottle to valve) R2 Yes

Dispense level (valve to

cuvette) R 1

100

Dispense level (valve to

cuvette) R 2

100

6 Method Rate

7 Wavelength 1 340

Wavelength 2 380

8 Reaction slop -

9 Measuring point start 9

Measuring point end 16

10 O.D. value range max 2.000

O.D. value range min 0.000

11 Limit of Linearity % 15

12 Normal value H 41

Normal value L 0

13 Dynamic range H 800

Dynamic range L 0

14 Panic value H #

Panic value L #

15 Reagent OD range

First Point H 2.000

First Point L -2.000

Last Point H 2.000

Last Point L -2.000

16 Decision level for repeat

run H

9999

Decision level for repeat

run L

0.0

17 R. dispence by black rack 0

18 R. dispence by black

interval

0

Calibration parameters

Calibration type MB

ODO – Conc. 0.000

Cal. No. {x}> #

Conc. > #

Factor range H

Factor range L

Factor **3515

Correlation correction

Correlation coefficient A

Correlation coefficient B

#) Data entry by the user

*) Calculated by the analyzer

**) Factor must be checked by calibration

serum

ASAT(GOT) FS (IFCC Mod)

Order information

Cat. No. Kit size

10 260 021 R1 5 x 20 ml + R2 1 x 25 ml

10 260 022 R1 5 x 80 ml + R2 1 x 100 ml

10 260 023 R1 1 x 800 ml + R2 1 x 200 ml

For determination with pyridoxal-5-phosphate

activation additionally required:

10 501 030 6 x 3 ml

Notes

1. Please refer to the package insert for

ASAT(GOT) FS (IFCC Mod) 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.

Page 5: AU 5200 ALAT - Kovalent€¦ · Test parameters Item code GPT Function select No. 1. Operation Yes 2. Sample volume 15 3. Sample volume at repeat run 4 4. Reagent volume R1 200 Reagent

OLYMPUS AU 5200

Chemistry setting

Temperature : 37°C

Test parameters

Item code Bili D

Function select No. #

1. Operation Yes

2. Sample volume 20

3. Sample volume at repeat run 2

4. Reagent volume R1 280

Reagent volume R2 70

5. W 3 parameter

Prime (bottle to valve) R1 Yes

Prime (bottle to valve) R2 Yes

Dispense level (valve to

cuvette) R 1

100

Dispense level (valve to

cuvette) R 2

100

6 Method End

7 Wavelength 1 540

Wavelength 2 660

8 Reaction slop +

9 Measuring point start 2

Measuring point end 16

10 O.D. value range max 2.000

O.D. value range min 0.000

11 Limit of Linearity % -

12 Normal value H 0.3

Normal value L 0

13 Dynamic range H 10.0

Dynamic range L 0

14 Panic value H #

Panic value L #

15 Reagent OD range

First Point H 2.000

First Point L -2.000

Last Point H 2.000

Last Point L -2.000

16 Decision level for repeat

run H

9999

Decision level for repeat

run L

0.0

17 R. dispence by black rack 0

18 R. dispence by black

interval

0

Calibration parameters

Calibration type AB

ODO – Conc. 0.000

Cal. No. {x}> #

Conc. > #

Factor range H

Factor range L

Factor *

Correlation correction

Correlation coefficient A

Correlation coefficient B

#) Data entry by the user

*) Calculated by the analyzer

BILIRUBIN AUTO DIRECT FS

Order information

Cat. No. Kit size

10 082 021 R1 5 x 20 ml + R2 1 x 25 ml

10 082 022 R1 5 x 80 ml + R2 1 x 100 ml

10 082 023 R1 1 x 800 ml + R2 1 x 200 ml

Notes

1. Please refer to the package insert for

Bilirubin Auto Direct 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 of 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.

Page 6: AU 5200 ALAT - Kovalent€¦ · Test parameters Item code GPT Function select No. 1. Operation Yes 2. Sample volume 15 3. Sample volume at repeat run 4 4. Reagent volume R1 200 Reagent

OLYMPUS AU 5200

Chemistry setting

Temperature : 37°C

Test parameters

Item code Bili T

Function select No. #

1. Operation Yes

2. Sample volume 6

3. Sample volume at repeat run 2

4. Reagent volume R1 280

Reagent volume R2 70

5. W 3 parameter

Prime (bottle to valve) R1 Yes

Prime (bottle to valve) R2 Yes

Dispense level (valve to

cuvette) R 1

100

Dispense level (valve to

cuvette) R 2

100

6 Method End

7 Wavelength 1 540

Wavelength 2 660

8 Reaction slop +

9 Measuring point start 2

Measuring point end 16

10 O.D. value range max 2.000

O.D. value range min 0.000

11 Limit of Linearity % -

12 Normal value H 1.1

Normal value L 0

13 Dynamic range H 30.0

Dynamic range L 0

14 Panic value H #

Panic value L #

15 Reagent OD range

First Point H 2.000

First Point L -2.000

Last Point H 2.000

Last Point L -2.000

16 Decision level for repeat

run H

9999

Decision level for repeat

run L

0.0

17 R. dispence by black rack 0

18 R. dispence by black

interval

0

Calibration parameters

Calibration type AB

ODO – Conc. 0.000

Cal. No. {x}> #

Conc. > #

Factor range H

Factor range L

Factor *

Correlation correction

Correlation coefficient A

Correlation coefficient B

#) Data entry by the user

*) Calculated by the analyzer

BILIRUBIN AUTO TOTAL FS

Order information

Cat. No. Kit size

10 081 021 R1 5 x 20 ml + R2 1 x 25 ml

10 081 022 R1 5 x 80 ml + R2 1 x 100 ml

10 081 023 R1 1 x 800 ml + R2 1 x 200 ml

Notes

1. Please refer to the package insert for

Bilirubin Auto Total 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 of 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.

Page 7: AU 5200 ALAT - Kovalent€¦ · Test parameters Item code GPT Function select No. 1. Operation Yes 2. Sample volume 15 3. Sample volume at repeat run 4 4. Reagent volume R1 200 Reagent

OLYMPUS AU 5200

Chemistry setting

Temperature : 37°C

Test parameters

Item code Calc

Function select No. #

1. Operation Yes

2. Sample volume 3

3. Sample volume at repeat run 2

4. Reagent volume R1 250

Reagent volume R2

5. W 3 parameter

Prime (bottle to valve) R1 Yes

Prime (bottle to valve) R2

Dispense level (valve to

cuvette) R 1

100

Dispense level (valve to

cuvette) R 2

6 Method end

7 Wavelength 1 660

Wavelength 2 800

8 Reaction slop +

9 Measuring point start 0

Measuring point end 16

10 O.D. value range max 2.000

O.D. value range min 0.000

11 Limit of Linearity % -

12 Normal value H 10.3

Normal value L 8.6

13 Dynamic range H 25.0

Dynamic range L 0

14 Panic value H #

Panic value L #

15 Reagent OD range

First Point H 2.000

First Point L -2.000

Last Point H 2.000

Last Point L -2.000

16 Decision level for repeat

run H

9999

Decision level for repeat

run L

0.0

17 R. dispence by black rack 0

18 R. dispence by black

interval

0

Calibration parameters

Calibration type AB

ODO – Conc. 0.000

Cal. No. {x}> #

Conc. > #

Factor range H -

Factor range L -

Factor *

Correlation correction

Correlation coefficient A -

Correlation coefficient B -

#) Data entry by the user

*) Calculated by the analyzer

CALCIUM AS FS Order information Cat. No. Kit size 1 1130 99 10 021 R 5 x 25 ml + 1 x 3 ml Std

1 1130 99 10 026 R 6 x 100 ml

1 1130 99 10 023 R 1 x 1000 ml

1 1130 99 10 030 6 x 3 ml Standard

1 1130 99 10 717 R 6 x 100 ml

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 & Co.KG Alte Strasse 9, 65558 Holzheim, Germany

Page 8: AU 5200 ALAT - Kovalent€¦ · Test parameters Item code GPT Function select No. 1. Operation Yes 2. Sample volume 15 3. Sample volume at repeat run 4 4. Reagent volume R1 200 Reagent

OLYMPUS AU 5200

Chemistry setting

Temperature : 37°C

Test parameters

Item code Chol

Function select No. #

1. Operation Yes

2. Sample volume 3

3. Sample volume at repeat run 2

4. Reagent volume R1 250

Reagent volume R2

5. W 3 parameter

Prime (bottle to valve) R1 Yes

Prime (bottle to valve) R2

Dispense level (valve to

cuvette) R 1

100

Dispense level (valve to

cuvette) R 2

6 Method end

7 Wavelength 1 520

Wavelength 2 660

8 Reaction slop +

9 Measuring point start 0

Measuring point end 16

10 O.D. value range max 2.000

O.D. value range min 0.000

11 Limit of Linearity % -

12 Normal value H 220

Normal value L 120

13 Dynamic range H 750

Dynamic range L 0

14 Panic value H #

Panic value L #

15 Reagent OD range

First Point H 2.000

First Point L -2.000

Last Point H 2.000

Last Point L -2.000

16 Decision level for repeat

run H

9999

Decision level for repeat

run L

0.0

17 R. dispence by black rack 0

18 R. dispence by black

interval

0

Calibration parameters

Calibration type AB

ODO – Conc. 0.000

Cal. No. {x}> #

Conc. > #

Factor range H -

Factor range L -

Factor *

Correlation correction

Correlation coefficient A -

Correlation coefficient B -

#) Data entry by the user

*) Calculated by the analyzer

CHOLESTEROL FS

Order information

Cat. No. Kit size

10 130 021 R 5 x 25 ml + 1 x 3 ml Std

1 1300 99 10 026 R 6 x 100 ml

10 130 023 R 1 x 1000 ml

10 130 030 6 x 3 ml Standard

Notes

1. Please refer to the package insert for

Cholesterol 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.

Page 9: AU 5200 ALAT - Kovalent€¦ · Test parameters Item code GPT Function select No. 1. Operation Yes 2. Sample volume 15 3. Sample volume at repeat run 4 4. Reagent volume R1 200 Reagent

OLYMPUS AU 5200

Chemistry setting

Temperature : 37°C

Test parameters

Item code CKMB

Function select No.

1. Operation Yes

2. Sample volume 10

3. Sample volume at repeat run 5

4. Reagent volume R1 200

Reagent volume R2 50

5. W 3 parameter

Prime (bottle to valve) R1 Yes

Prime (bottle to valve) R2 Yes

Dispense level (valve to

cuvette) R 1

100

Dispense level (valve to

cuvette) R 2

100

6 Method Rate

7 Wavelength 1 340

Wavelength 2 380

8 Reaction slop +

9 Measuring point start 10

Measuring point end 16

10 O.D. value range max 2.000

O.D. value range min 0.000

11 Limit of Linearity % 15

12 Normal value H 24

Normal value L 0

13 Dynamic range H 1000

Dynamic range L 0

14 Panic value H #

Panic value L #

15 Reagent OD range

First Point H 2.000

First Point L -2.000

Last Point H 2.000

Last Point L -2.000

16 Decision level for repeat

run H

9999

Decision level for repeat

run L

0.0

17 R. dispence by black rack 0

18 R. dispence by black

interval

0

Calibration parameters

Calibration type MCAL type

ODO – Conc. 0.000

Cal. No. {x}> #

Conc. > #

Factor range H

Factor range L

Factor **8250

Correlation correction

Correlation coefficient A

Correlation coefficient B

#) Data entry by the user

*) Calculated by the analyzer

**) Factor must be checked by calibration

serum

CK-MB FS

Order information

Cat. No. Kit size

10 165 021 R1 5 x 20 ml + R2 1 x 25 ml

10 165 022 R1 5 x 80 ml + R2 1 x 100 ml

10 165 023 R1 1 x 800 ml + R2 1 x 200 ml

Notes

1. Please refer to the package insert for CK-MB

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.

Page 10: AU 5200 ALAT - Kovalent€¦ · Test parameters Item code GPT Function select No. 1. Operation Yes 2. Sample volume 15 3. Sample volume at repeat run 4 4. Reagent volume R1 200 Reagent

OLYMPUS AU 5200

Chemistry setting

Temperature : 37°C

Test parameters

Item code CKNAC

Function select No. #

1. Operation Yes

2. Sample volume 7

3. Sample volume at repeat run 2

4. Reagent volume R1 200

Reagent volume R2 50

5. W 3 parameter

Prime (bottle to valve) R1 Yes

Prime (bottle to valve) R2 Yes

Dispense level (valve to

cuvette) R 1

100

Dispense level (valve to

cuvette) R 2

100

6 Method Rate

7 Wavelength 1 340

Wavelength 2 380

8 Reaction slop +

9 Measuring point start 11

Measuring point end 16

10 O.D. value range max 2.000

O.D. value range min 0.000

11 Limit of Linearity % 15

12 Normal value H 190

Normal value L 0

13 Dynamic range H 1000

Dynamic range L 0

14 Panic value H #

Panic value L #

15 Reagent OD range

First Point H 2.000

First Point L -2.000

Last Point H 2.000

Last Point L -2.000

16 Decision level for repeat

run H

9999

Decision level for repeat

run L

0.0

17 R. dispence by black rack 0

18 R. dispence by black

interval

0

Calibration parameters

Calibration type MB

ODO – Conc. 0.000

Cal. No. {x}> #

Conc. > #

Factor range H

Factor range L

Factor **

Correlation correction

Correlation coefficient A

Correlation coefficient B

#) Data entry by the user

*) Calculated by the analyzer

**) Factor must be checked by calibration

serum

CK-NAC FS

Order information

Cat. No. Kit size

10 160 021 R1 5 x 20 ml + R2 1 x 25 ml

10 160 022 R1 5 x 80 ml + R2 1 x 100 ml

10 160 023 R1 1 x 800 ml + R2 1 x 200 ml

Notes

1. Please refer to the package insert for CK-

NAC 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 of 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.

Page 11: AU 5200 ALAT - Kovalent€¦ · Test parameters Item code GPT Function select No. 1. Operation Yes 2. Sample volume 15 3. Sample volume at repeat run 4 4. Reagent volume R1 200 Reagent

OLYMPUS AU 5200

Chemistry setting Temperature : 37°C

Test parameters

Item code Creat

Function select No. #

1. Operation Yes 2. Sample volume 12

3. Sample volume at repeat run 2 4. Reagent volume R1 240 Reagent volume R2 60 5. W 3 parameter

Prime (bottle to valve) R1 Yes Prime (bottle to valve) R2 Yes Dispense level (valve to cuvette) R 1 100 Dispense level (valve to cuvette) R 2 100

6 Method Rate 7 Wavelength 1 520 Wavelength 2 660 8 Reaction slop +

9 Measuring point start 9 Measuring point end 13 10 O.D. value range max 2.000 O.D. value range min 0.000

11 Limit of Linearity % 25 12 Normal value H 0.6 Normal value L 1.3 13 Dynamic range H 15.0

Dynamic range L 0 14 Panic value H # Panic value L # 15 Reagent OD range

First Point H 2.000 First Point L -2.000 Last Point H 2.000 Last Point L -2.000

16 Decision level for repeat run H 9999 Decision level for repeat run L 0.0 17 R. dispence by black rack 0

18 R. dispence by black interval 0

Calibration parameters

Calibration type AB ODO – Conc. 0.000 Cal. No. {x}> #

Conc. > # Factor range H Factor range L Factor *

Correlation correction

Correlation coefficient A Correlation coefficient B

#) Data entry by the user

*) Calculated by the analyzer

CREATININE FS

Order information Cat. No. Kit size

10 171 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3ml Std

1 1711 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml

10 171 023 R1 1 x 800 ml + R2 1 x 200 ml

10 170 030 6 x 3 ml Standard

Notes

1. Please refer to the package insert for Creatinine 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 of 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.

Page 12: AU 5200 ALAT - Kovalent€¦ · Test parameters Item code GPT Function select No. 1. Operation Yes 2. Sample volume 15 3. Sample volume at repeat run 4 4. Reagent volume R1 200 Reagent

CRP FS*

Order information Cat. No. Kit size 1 7002 99 10 015 R1 2 x 25 ml + R2 1 x 10 ml 10 700 021 R1 5 x 25 ml + R2 1 x 25 ml 10 700 023 R1 1 x 1000 ml + R2 1 x 200 ml 1 7000 99 10 039 1 x 2 ml Calibrator Level 1 1 x 2 ml Calibrator Level 2 1 x 2 ml Calibrator Level 3 1 x 2 ml Calibrator Level 4 1 x 2 ml Calibrator Level 5

Method Immunological turbidimetric test

Endpoint determination of the concentration of CRP through photometric measurement of antigen-antibody-reaction. Calculation: 1-point or multi-point calibration

Reagent preparation and stability The reagents and calibrators are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C.

Specimen Serum, heparinized or EDTA plasma. Anticoagulants in usual concentration do not interfere. Avoid hemolysis! Stability: 8 days at 2 - 8 °C 3 months at - 20 °C (not in case of repeated deep freezing)

Prozone limit up to at least 200 mg/dl

Components and concentration in the test R1: Buffer TRIS pH 7.5 100 mmol/l PEG, detergents and stabilizers R2: Antiserum TRIS pH 8.0 100 mmol/l Anti-human CRP antibodies (goat) with stabilizers Calibrators:

stabilized human sera, concentrations are indicated on the label

Notes 1. The reagents contain Sodium Azide (0.095 %) as preservative.

Do not swallow! Avoid contact with skin and mucous membranes.

2. The calibrators were only produced with human sera from donors, where no HIV-antibodies and no HbsAg were detected by FDA-approved tests. As a risk of infection cannot be completely excluded, the calibrators should be handled as carefully as patient samples.

Normal range (see reference 3,4)

Adults up to 0.8 mg/dl Newborn up to 3 days up to 1.5 mg/dl Infants from the 4

th day and children up to 1.0 mg/dl

References 1. Skurk, A., Thomas, L., Lab. Med., 14, (1990), 111 – 115 2. Grützmeyer, S., von Schenck, H., Clin. Chem., 35,

(1989), 461 - 463 3. Claus, D. R., Osmand, A. P., Gewurz, H., J. Lab. Clin. Med., 87,

(1976), 120 – 128 4. Sabel, K.-G., Wadsworth, Ch., Acta Paediatr. Scand., 68,

(1979), 825 – 831

* fluid stable

OLYMPUS AU 5200

Chemistry setting Temperature : 37°C

Test parameters

Item code

Function select No.

1. Operation yes 2. Sample volume 15 3. Sample volume at repeat run 5 4. Reagent volume R1 250 Reagent volume R2 50 5. W 3 parameter Prime (bottle to valve) R1 yes Prime (bottle to valve) R2 yes Dispense level (valve to cuvette) R 1 100 Dispense level (valve to cuvette) R 2 100 6. Method end 7. Wavelength 1 340 Wavelength 2 660 8. Reaction slop + 9. Measuring point start 6 Measuring point end 16 10. O.D. value range max 2.000 O.D. value range min 0.000 11. Limit of Linearity % - 12. Normal value H 0.8 Normal value L 0.0 13. Dynamic range H 25.0 Dynamic range L 0.0 14. Panic value H # Panic value L # 15. Reagent OD range First Point H 2.000 First Point L -2.000 Last Point H 2.000 Last Point L -2.000 16. Decision level for repeat run H 9999 Decision level for repeat run L 0.0 17. R. dispence by black rack 0 18. R. dispence by black interval 0

Calibration parameters

Calibration type AB ODO – Conc. 0.000 Cal. No. {x}> # Conc. > * Factor range H - Factor range L - Factor **

Correlation correction

Correlation coefficient A Correlation coefficient B

#) Data entry by the user *) Calculated by the analyzer

11.02.11

Page 13: AU 5200 ALAT - Kovalent€¦ · Test parameters Item code GPT Function select No. 1. Operation Yes 2. Sample volume 15 3. Sample volume at repeat run 4 4. Reagent volume R1 200 Reagent

OLYMPUS AU 5200

Chemistry setting

Temperature : 37°C

Test parameters

Item code Gluc

Function select No. #

1. Operation Yes

2. Sample volume 3

3. Sample volume at repeat run 2

4. Reagent volume R1 300

Reagent volume R2

5. W 3 parameter

Prime (bottle to valve) R1 Yes

Prime (bottle to valve) R2

Dispense level (valve to

cuvette) R 1

100

Dispense level (valve to

cuvette) R 2

6 Method End

7 Wavelength 1 520

Wavelength 2 660

8 Reaction slop +

9 Measuring point start 0

Measuring point end 16

10 O.D. value range max 2.000

O.D. value range min 0.000

11 Limit of Linearity % -

12 Normal value H 115

Normal value L 75

13 Dynamic range H 400

Dynamic range L 0

14 Panic value H #

Panic value L #

15 Reagent OD range

First Point H 2.000

First Point L -2.000

Last Point H 2.000

Last Point L -2.000

16 Decision level for repeat

run H

9999

Decision level for repeat

run L

0.0

17 R. dispence by black rack 0

18 R. dispence by black

interval

0

Calibration parameters

Calibration type AB

ODO – Conc. 0.000

Cal. No. {x}> #

Conc. > #

Factor range H

Factor range L

Factor *

Correlation correction

Correlation coefficient A

Correlation coefficient B

#) Data entry by the user

*) Calculated by the analyzer

GLUCOSE GOD FS

Order information

Cat. No. Kit size

10 250 021 R 5 x 25 ml + 1 x 3 ml Std

1 2500 99 10 026 R 6 x 100 ml

10 250 023 R 1 x 1000 ml

10 250 030 6 x 3 ml Standard

Notes

1. Please refer to the package insert for

Glucose GOD 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 of 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.

Page 14: AU 5200 ALAT - Kovalent€¦ · Test parameters Item code GPT Function select No. 1. Operation Yes 2. Sample volume 15 3. Sample volume at repeat run 4 4. Reagent volume R1 200 Reagent

OLYMPUS AU 5200

Chemistry setting

Temperature : 37°C

Test parameters

Item code Gluc

Function select No. #

1. Operation Yes

2. Sample volume 3

3. Sample volume at repeat run 2

4. Reagent volume R1 280

Reagent volume R2 70

5. W 3 parameter

Prime (bottle to valve) R1 Yes

Prime (bottle to valve) R2 Yes

Dispense level (valve to

cuvette) R 1

100

Dispense level (valve to

cuvette) R 2

100

6 Method End

7 Wavelength 1 340

Wavelength 2 380

8 Reaction slop +

9 Measuring point start 5

Measuring point end 16

10 O.D. value range max 2.000

O.D. value range min 0.000

11 Limit of Linearity % 15

12 Normal value H 115

Normal value L 75

13 Dynamic range H 500

Dynamic range L 0

14 Panic value H #

Panic value L #

15 Reagent OD range

First Point H 2.000

First Point L -2.000

Last Point H 2.000

Last Point L -2.000

16 Decision level for repeat

run H

9999

Decision level for repeat

run L

0.0

17 R. dispence by black rack 0

18 R. dispence by black

interval

0

Calibration parameters

Calibration type AB

ODO – Conc. 0.000

Cal. No. {x}> #

Conc. > #

Factor range H

Factor range L

Factor *

Correlation correction

Correlation coefficient A

Correlation coefficient B

#) Data entry by the user

*) Calculated by the analyzer

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 of 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.

Page 15: AU 5200 ALAT - Kovalent€¦ · Test parameters Item code GPT Function select No. 1. Operation Yes 2. Sample volume 15 3. Sample volume at repeat run 4 4. Reagent volume R1 200 Reagent

OLYMPUS AU 5200

Chemistry setting Temperature : 37°C

Test parameters

Item code Iron

Function select No. #

1. Operation Yes 2. Sample volume 15

3. Sample volume at repeat run 3 4. Reagent volume R1 280 Reagent volume R2 70 5. W 3 parameter

Prime (bottle to valve) R1 Yes Prime (bottle to valve) R2 Yes Dispense level (valve to cuvette) R 1 100 Dispense level (valve to cuvette) R 2 100

6 Method End 7 Wavelength 1 600 Wavelength 2 800 8 Reaction slop +

9 Measuring point start 2 Measuring point end 16 10 O.D. value range max 2.000 O.D. value range min 0.000

11 Limit of Linearity % - 12 Normal value H 168 Normal value L 23 13 Dynamic range H 1000

Dynamic range L 0 14 Panic value H # Panic value L # 15 Reagent OD range

First Point H 2.000 First Point L -2.000 Last Point H 2.000 Last Point L -2.000

16 Decision level for repeat run H 9999 Decision level for repeat run L 0.0 17 R. dispence by black rack 0

18 R. dispence by black interval 0

Calibration parameters

Calibration type AB ODO – Conc. 0.000 Cal. No. {x}> #

Conc. > # Factor range H Factor range L Factor *

Correlation correction

Correlation coefficient A Correlation coefficient B

#) Data entry by the user

*) Calculated by the analyzer

IRON FS

Order information

Cat. No. Kit size 10 190 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3ml Std

1 1901 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml

10 190 023 R1 1 x 800 ml + R2 1 x 200 ml

10 190 030 6 x 3 ml standard

10 190 717 R1 5x 80 ml + R2 5 x 20 ml

Notes

1. Please refer to the package insert for Iron 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 of 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.

Page 16: AU 5200 ALAT - Kovalent€¦ · Test parameters Item code GPT Function select No. 1. Operation Yes 2. Sample volume 15 3. Sample volume at repeat run 4 4. Reagent volume R1 200 Reagent

OLYMPUS AU 5200

Chemistry setting

Temperature : 37°C

Test parameters

Item code LDH

Function select No.

1. Operation Yes

2. Sample volume 5

3. Sample volume at repeat run 2

4. Reagent volume R1 200

Reagent volume R2 50

5. W 3 parameter

Prime (bottle to valve) R1 Yes

Prime (bottle to valve) R2 Yes

Dispense level (valve to

cuvette) R 1

100

Dispense level (valve to

cuvette) R 2

100

6 Method Rate

7 Wavelength 1 340

Wavelength 2 380

8 Reaction slop -

9 Measuring point start 9

Measuring point end 16

10 O.D. value range max 2.000

O.D. value range min 0.000

11 Limit of Linearity % 15

12 Normal value H 480

Normal value L 0

13 Dynamic range H 2000

Dynamic range L 0

14 Panic value H #

Panic value L #

15 Reagent OD range

First Point H 2.000

First Point L -2.000

Last Point H 2.000

Last Point L -2.000

16 Decision level for repeat

run H

9999

Decision level for repeat

run L

0.0

17 R. dispence by black rack 0

18 R. dispence by black

interval

0

Calibration parameters

Calibration type MB

ODO – Conc. 0.000

Cal. No. {x}> #

Conc. > #

Factor range H

Factor range L

Factor **

Correlation correction

Correlation coefficient A

Correlation coefficient B

#) Data entry by the user

*) Calculated by the analyzer

**) Factor must be checked by calibration

serum

LDH FS DGKC

Order information

Cat. No. Kit size

10 420 021 R1 5 x 20 ml + R2 1 x 25 ml

10 420 022 R1 5 x 80 ml + R2 1 x 100 ml

10 420 023 R1 1 x 800 ml + R2 1 x 200 ml

Notes

1. Please refer to the package insert for LDH

FS DGKC 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.

Page 17: AU 5200 ALAT - Kovalent€¦ · Test parameters Item code GPT Function select No. 1. Operation Yes 2. Sample volume 15 3. Sample volume at repeat run 4 4. Reagent volume R1 200 Reagent

OLYMPUS AU 5200

Chemistry setting

Temperature : 37°C

Test parameters

Item code Phos

Function select No. #

1. Operation Yes

2. Sample volume 3

3. Sample volume at repeat run 1

4. Reagent volume R1 250

Reagent volume R2

5. W 3 parameter

Prime (bottle to valve) R1 Yes

Prime (bottle to valve) R2

Dispense level (valve to

cuvette) R 1

100

Dispense level (valve to

cuvette) R 2

6 Method end

7 Wavelength 1 340

Wavelength 2 380

8 Reaction slop +

9 Measuring point start 0

Measuring point end 16

10 O.D. value range max 2.000

O.D. value range min 0.000

11 Limit of Linearity % -

12 Normal value H 5.0

Normal value L 2.5

13 Dynamic range H 20.0

Dynamic range L 0.0

14 Panic value H #

Panic value L #

15 Reagent OD range

First Point H 2.000

First Point L -2.000

Last Point H 2.000

Last Point L -2.000

16 Decision level for repeat

run H

9999

Decision level for repeat

run L

0.0

17 R. dispence by black rack 0

18 R. dispence by black

interval

0

Calibration parameters

Calibration type AB

ODO – Conc. 0.000

Cal. No. {x}> #

Conc. > #

Factor range H -

Factor range L -

Factor *

Correlation correction

Correlation coefficient A -

Correlation coefficient B -

#) Data entry by the user

*) Calculated by the analyzer

PHOSPHORUS UV FS

Order information

Cat. No. Kit size

10 520 021 R 5 x 25 ml + 1 x 3 ml Standard

1 5200 99 10 026 R 6 x 100 ml

10 520 023 R 1 x 1000 ml

10 520 030 6 x 3 ml Standard

10 520 717 R 6 x 100 ml

Notes

1. Please refer to the package insert for

Phosphorus UV 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.

Page 18: AU 5200 ALAT - Kovalent€¦ · Test parameters Item code GPT Function select No. 1. Operation Yes 2. Sample volume 15 3. Sample volume at repeat run 4 4. Reagent volume R1 200 Reagent

OLYMPUS AU 5200

Chemistry setting

Temperature : 37°C

Test parameters

Item code Trig

Function select No. #

1. Operation Yes

2. Sample volume 3

3. Sample volume at repeat run 2

4. Reagent volume R1 250

Reagent volume R2

5. W 3 parameter

Prime (bottle to valve) R1 Yes

Prime (bottle to valve) R2

Dispense level (valve to

cuvette) R 1

100

Dispense level (valve to

cuvette) R 2

6 Method end

7 Wavelength 1 520

Wavelength 2 660

8 Reaction slop +

9 Measuring point start 0

Measuring point end 16

10 O.D. value range max 2.000

O.D. value range min 0.000

11 Limit of Linearity % -

12 Normal value H 200

Normal value L 0

13 Dynamic range H 1000

Dynamic range L 0

14 Panic value H #

Panic value L #

15 Reagent OD range

First Point H 2.000

First Point L -2.000

Last Point H 2.000

Last Point L -2.000

16 Decision level for repeat

run H

9999

Decision level for repeat

run L

0.0

17 R. dispence by black rack 0

18 R. dispence by black

interval

0

Calibration parameters

Calibration type AB

ODO – Conc. 0.000

Cal. No. {x}> #

Conc. > #

Factor range H -

Factor range L -

Factor *

Correlation correction

Correlation coefficient A -

Correlation coefficient B -

#) Data entry by the user

*) Calculated by the analyzer

TRIGLYCERIDES FS

Order information

Cat. No. Kit size

10 571 021 R 5 x 25 ml + 1 x 3 ml Std

1 5710 99 10 026 R 6 x 100 ml

10 571 023 R 1 x 1000 ml

10 571 030 6 x 3 ml Standard

Notes

1. Please refer to the package insert for

Triglycerides 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.

Page 19: AU 5200 ALAT - Kovalent€¦ · Test parameters Item code GPT Function select No. 1. Operation Yes 2. Sample volume 15 3. Sample volume at repeat run 4 4. Reagent volume R1 200 Reagent

OLYMPUS AU 5200

Chemistry setting

Temperature : 37°C

Test parameters

Item code Urea

Function select No. #

1. Operation Yes

2. Sample volume 3

3. Sample volume at repeat run 2

4. Reagent volume R1 240

Reagent volume R2 60

5. W 3 parameter

Prime (bottle to valve) R1 Yes

Prime (bottle to valve) R2 Yes

Dispense level (valve to

cuvette) R 1

100

Dispense level (valve to

cuvette) R 2

100

6 Method Rate

7 Wavelength 1 340

Wavelength 2 380

8 Reaction slop -

9 Measuring point start 9

Measuring point end 12

10 O.D. value range max 2.000

O.D. value range min 0.000

11 Limit of Linearity % 25

12 Normal value H 43

Normal value L 17

13 Dynamic range H 300

Dynamic range L 0

14 Panic value H #

Panic value L #

15 Reagent OD range

First Point H 2.000

First Point L -2.000

Last Point H 2.000

Last Point L -2.000

16 Decision level for repeat

run H

9999

Decision level for repeat

run L

0.0

17 R. dispence by black rack 0

18 R. dispence by black

interval

0

Calibration parameters

Calibration type AB

ODO – Conc. 0.000

Cal. No. {x}> #

Conc. > #

Factor range H

Factor range L

Factor *

Correlation correction

Correlation coefficient A

Correlation coefficient B

#) Data entry by the user

*) Calculated by the analyzer

UREA FS

Order information

Cat. No. Kit size

10 310 021 R1 4 x 20 ml + R2 1 x 20 ml

+ 1 x 3ml Std

1 3101 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml

10 310 023 R1 1 x 800 ml + R2 1 x 200 ml

10 310 030 6 x 3 ml standard

Notes

1. Please refer to the package insert for Urea

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 of 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.

Page 20: AU 5200 ALAT - Kovalent€¦ · Test parameters Item code GPT Function select No. 1. Operation Yes 2. Sample volume 15 3. Sample volume at repeat run 4 4. Reagent volume R1 200 Reagent

nUric acid Fs*

TBHBA

Order information Cat. No. Kit size 10 302 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3 ml std. 1 3021 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml 10 302 023 R1 1 x 800

ml + R2 1 x 200 ml

10 300 030 6 x 3 ml standard

Method Enzymatic colorimetric test, “TBHBA“

Uric acid is oxidized to Allantoine by Uricase. The generated Hydrogen Peroxide reacts with 4-Aminoantipyrine and 2,4,6-Tribromo-3-hydroxybenzoic acid (TBHBA) to Chinonimine.

Reagent preparation and stability The reagents and the standard are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. The reagents must be protected from light.

Specimen

Serum, heparinized or EDTA plasma, urine. For serum / plasma: Avoid hemolysis! Dilute urine 1 + 10 with distilled water.

Components and concentration in the test

R1: Phosphate buffer pH 7.0 100 mmol/l TBHBA (2,4,6-Tribromo-3-Hydroxy-

benzoic acid) 1 mmol/l

R2: Phosphate buffer pH 7.0 100 mmol/l 4-Aminoantipyrine 0,3 mmol/l Potassiumhexacyanoferrate (II) 10 µmol/l POD > 2 KU/l Uricase > 30 U/l Standard: 6 mg/dl (357 µmol/l)

Notes

Ascorbic acid interferes.

Normal range (see reference 1,2)

Serum: Men: 3.4 - 7.0 mg/dl (200 - 420 µmol/l) Women: 2.4 - 5.7 mg/dl (140 - 340 µmol/l) Urine: 250 - 750 mg/24 h (1.5 - 4.5 mmol/24 h)

References

1. Thefeld, W., Hoffmeister, H., Busch, E.-W., Koller, P. U., Vollmar, J., Dtsch. Med. Wschr., 98, (1973), 380 – 384

2. Henry, R. J., Cannon, D. C., Winkelmann, J.: Clinical Chemistry, Principles and Technics, 2

nd edition, Harper & Row Publishers

Inc., Hagerstown Maryland 1974, 534 3. Trinder, P., Ann. Clin. Biochem., 6, (1969), 24 - 27 4. Town, M.-H., Gehm, S., Hammer, B., Ziegenhorn, J.,

J. Clin. Chem. Clin. Biochem., 23, (1985), 591 * fluid stable

OLYMPUS AU 5200

Chemistry setting Temperature : 37°C

Test parameters

Item code

Function select No.

1. Operation yes 2. Sample volume 5 3. Sample volume at repeat run 3 4. Reagent volume R1 240 Reagent volume R2 60 5. W 3 parameter Prime (bottle to valve) R1 yes Prime (bottle to valve) R2 yes Dispense level (valve to cuvette) R 1 100 Dispense level (valve to cuvette) R 2 100 6. Method end 7. Wavelength 1 520 Wavelength 2 800 8. Reaction slope + 9. Measuring point start 6 Measuring point end 16 10. O.D. value range max 2.000 O.D. value range min 0.000 11. Limit of Linearity % - 12. Normal value H 7.0 Normal value L 2.4 13. Dynamic range H 20.0 Dynamic range L 0.0 14. Panic value H # Panic value L # 15. Reagent OD range First Point H 2.000 First Point L -2.000 Last Point H 2.000 Last Point L -2.000 16. Decision level for repeat run H 9999 Decision level for repeat run L 0.0 17. R. dispence by black rack 0 18. R. dispence by black interval 0

Calibration parameters

Calibration type AB ODO – Conc. 0.000 Cal. No. {x}> # Conc. > * Factor range H - Factor range L - Factor *

Correlation correction

Correlation coefficient A Correlation coefficient B

#) Data entry by the user *) Calculated by the analyzer

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Page 21: AU 5200 ALAT - Kovalent€¦ · Test parameters Item code GPT Function select No. 1. Operation Yes 2. Sample volume 15 3. Sample volume at repeat run 4 4. Reagent volume R1 200 Reagent

March 2010/3

OLYMPUS AU 5400 Specific Test Parameters General

Test Name CA Type Serum Operation Yes

Sample Volume 2.0 µl Dilution 0 µl

Reagents R1 Volume 160 µl Dilution 0 µl

R2 Volume 40 µl Dilution 0 µl

Wavelength Pri 660 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 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 P FS Order information

Cat. No. 1 1181 .. .. …

Notes

1. Please refer to the package insert for Calcium P 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 7 weeks

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 1181 10 02 25