34
April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim. Wave 546 Sec Wave 700 Sample Vol 6 R1 Vol. 240 R2 Vol. 60 Line Limit 20 Response Incubation 25 Antigen Check Antigen Lower 0 Full Name Uric Acid Reaction -2 - 25 Substrate 0 Upper 0 Print No. # R1 Blank Mix R Blank Linearity Lower 0 Lower 0 Lower 0.07 Factor 0 Upper 0 Upper 0 Upper 20.0 Speed 0 Calibration Request Rule Two point Linear Replicates 2 Difference 0 Interval 0 Blank Response 0 0 Sensitivity 0 Coeff Difference 0 Correlation 0 Non-Linear SD 0 # entered by the user 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. **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

  • Upload
    vannhi

  • View
    230

  • Download
    0

Embed Size (px)

Citation preview

Page 1: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

April 2006/2

Uric Acid FS TBHBA Mindray BS300

Parameters

No # Test Uric Acid Method Endpoint Direction Ascend

Unit mg/dl Decimals 1 Prim. Wave 546 Sec Wave 700

Sample Vol 6 R1 Vol. 240 R2 Vol. 60 Line Limit 20

Response

Incubation 25 Antigen Check Antigen Lower 0 Full Name Uric Acid

Reaction -2 - 25 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 0.07 Factor 0

Upper 0 Upper 0 Upper 20.0 Speed 0

Calibration

Request

Rule Two point Linear

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

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.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 2: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

December 2006/2

-AMYLASE CC FS Mindray BS300

Parameters

No # Test AMY Method Kinetic Direction Ascend

Unit U/l Decimals 1 Prim. Wave 405 Sec Wave 700

Sample Vol 5 R1 Vol. 200 R2 Vol. 50 Line Limit 20

Response

Incubation 25 Antigen Check Antigen Lower 0 Full Name Amylase

Reaction 8 - 25 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 0 Factor 0

Upper 0 Upper 0 Upper 2000 Speed 0

Calibration

Request

Rule Two point Linear

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

Order information Cat. No. 1 0501 .. .. …

Notes

1. Please refer to the package insert for -Amylase CC 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 3: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

April 2006/2

Bicarbonate FS Mindray BS300

Parameters

No # Test BIC Method Endpoint Direction Descend

Unit mmol/l Decimals 1 Prim. Wave 405 Sec Wave 510

Sample Vol 15 R1 Vol. 200 R2 Vol. 0 Line Limit 20

Response

Incubation 0 Antigen Check Antigen Lower 0 Full Name Bicarbonate

Reaction 3 - 15 Substrate 2.5 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 0 Factor 0

Upper 0 Upper 0 Upper 50 Speed 0

Calibration

Request

Rule Two point Linear

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

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 4: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

April 2006/2

Bilirubin Auto Direct FS Mindray BS300

Parameters

No # Test BiliD Method Endpoint Direction Ascend

Unit mg/dl Decimals 2 Prim. Wave 546 Sec Wave 670

Sample Vol 10 R1 Vol. 240 R2 Vol. 60 Line Limit 20

Response

Incubation 25 Antigen Check Antigen Lower 0 Full Name Bili Direct

Reaction -2 - 25 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 0 Factor 0

Upper 0 Upper 0 Upper 10.0 Speed 0

Calibration

Request

Rule Two point Linear

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

Order information Cat. No. 1 0821 .. .. …

Notes

1. Please refer to the package insert for Bilirubin Auto Direct 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 5: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

April 2006/2

Bilirubin Auto Total FS Mindray BS300

Parameters

No # Test BiliT Method Endpoint Direction Ascend

Unit mg/dl Decimals 1 Prim. Wave 546 Sec Wave 670

Sample Vol 6 R1 Vol. 240 R2 Vol. 60 Line Limit 20

Response

Incubation 25 Antigen Check Antigen Lower 0 Full Name Bili Total

Reaction -2 - 25 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 0 Factor 0

Upper 0 Upper 0 Upper 30.0 Speed 0

Calibration

Request

Rule Two point Linear

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

Order information Cat. No. 1 0811 .. .. …

Notes

1. Please refer to the package insert for Bilirubin Auto Total 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 6: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

April 2006/2

Calcium AS FS Mindray BS300

Parameters

No # Test Ca AS Method Endpoint Direction Ascend

Unit mg/dl Decimals 1 Prim. Wave 670 Sec Wave 700

Sample Vol 3 R1 Vol. 250 R2 Vol. 0 Line Limit 20

Response

Incubation 0 Antigen Check Antigen Lower 0 Full Name Calcium

Reaction 0 - 25 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 0.04 Factor 0

Upper 0 Upper 0 Upper 25.0 Speed 0

Calibration

Request

Rule Two point Linear

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

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.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 7: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

January 2008/1

CK-MB FS (IFCC mod.) Mindray BS300

Parameters

No # Test CKMB Method Kinetic Direction Asscend

Unit U/l Decimals 1 Prim. Wave 340 Sec Wave 405

Sample Vol 10 R1 Vol. 200 R2 Vol. 50 Line Limit 20

Response

Incubation 25 Antigen Check Antigen Lower 0 Full Name CK-MB

Reaction 15 - 25 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 0 Factor 0

Upper 0 Upper 0 Upper 1500 Speed 0

Calibration

Request

Rule Two point Linear

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

Order information Cat. No. 1 1651 .. .. …

Notes

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

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 8: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

January 2008/1

CK-NAC FS (IFCC mod.) Mindray BS300

Parameters

No # Test CK Method Kinetic Direction Asscend

Unit U/l Decimals 1 Prim. Wave 340 Sec Wave 405

Sample Vol 10 R1 Vol. 200 R2 Vol. 50 Line Limit 20

Response

Incubation 25 Antigen Check Antigen Lower 0 Full Name CK-NAC

Reaction 15 - 25 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 0 Factor 0

Upper 0 Upper 0 Upper 2000 Speed 0

Calibration

Request

Rule Two point Linear

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

Order information Cat. No. 1 1601 .. .. …

Notes

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

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 9: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

April 2006/2

Chloride FS Mindray BS300

Parameters

No # Test Cl Method Endpoint Direction Ascend

Unit mmol/l Decimals 0 Prim. Wave 450 Sec Wave 700

Sample Vol 3 R1 Vol. 250 R2 Vol. 0 Line Limit 20

Response

Incubation 0 Antigen Check Antigen Lower 0 Full Name Chloride

Reaction 0 - 25 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 1 Factor 0

Upper 0 Upper 0 Upper 130 Speed 0

Calibration

Request

Rule Two point Linear

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

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.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 10: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

April 2006/2

Cholesterol FS Mindray BS300

Parameters

No # Test CHOL Method Endpoint Direction Ascend

Unit mg/dl Decimals 0 Prim. Wave 510 Sec Wave 700

Sample Vol 3 R1 Vol. 250 R2 Vol. 0 Line Limit 20

Response

Incubation 0 Antigen Check Antigen Lower 0 Full Name Cholesterol

Reaction 0 - 25 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 3 Factor 0

Upper 0 Upper 0 Upper 750 Speed 0

Calibration

Request

Rule Two point Linear

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

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.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 11: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

July 2006/3

Cholinesterase FS Mindray BS300

Parameters

No # Test CHE Method Kinetic Direction Descend

Unit U/l Decimals 0 Prim. Wave 405 Sec Wave 0

Sample Vol 4 R1 Vol. 200 R2 Vol. 50 Line Limit 20

Response

Incubation 25 Antigen Check Antigen Lower 0 Full Name CHE

Reaction 7 - 25 Substrate 2.5 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 0 Factor 0

Upper 0 Upper 0 Upper 20000 Speed 0

Calibration

Request

Rule Two point Linear

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

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.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 12: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

April 2006/2

Creatinine FS Mindray BS300

Parameters

No # Test Crea Method Endpoint Direction Ascend

Unit mg/dl Decimals 1 Prim. Wave 510 Sec Wave 578

Sample Vol 15 R1 Vol. 200 R2 Vol. 50 Line Limit 20

Response

Incubation 25 Antigen Check Antigen Lower 0 Full Name Creatinine

Reaction 5 - 13 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 0.2 Factor 0

Upper 0 Upper 0 Upper 15.0 Speed 0

Calibration

Request

Rule Two point Linear

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

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.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 13: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

April 2006/2

Ferritin FS Mindray BS300

Parameters

No # Test Ferritin Method Fixed Time Direction Ascend

Unit µg/dl Decimals 1 Prim. Wave 578 Sec Wave 700

Sample Vol 9 R1 Vol. 180 R2 Vol. 90 Line Limit 20

Response

Incubation 25 Antigen Check Antigen Lower 0 Full Name Ferritin

Reaction 3 - 25 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 5 Factor 0

Upper 0 Upper 0 Upper 1000 Speed 0

Calibration

Request

Rule 5P Logit Log

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

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 14: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

April 2006/2

Iron FS Ferene Mindray BS300

Parameters

No # Test Fe Method Endpoint Direction Ascend

Unit µg/dl Decimals 1 Prim. Wave 630 Sec Wave 700

Sample Vol 15 R1 Vol. 240 R2 Vol. 60 Line Limit 20

Response

Incubation 25 Antigen Check Antigen Lower 0 Full Name Iron

Reaction -2 - 25 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 5 Factor 0

Upper 0 Upper 0 Upper 1000 Speed 0

Calibration

Request

Rule Two point Linear

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

Order information Cat. No. 1 1911 .. .. …

Notes

1. Please refer to the package insert for Iron FS Ferene 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 15: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

December 2006/2

Alkaline Phosphatase FS IFCC 37°C Mindray BS300

Parameters

No # Test ALP IFCC Method Kinetic Direction Ascend

Unit U/l Decimals 1 Prim. Wave 405 Sec Wave 700

Sample Vol 4 R1 Vol. 200 R2 Vol. 50 Line Limit 20

Response

Incubation 25 Antigen Check Antigen Lower 0 Full Name ALP IFCC

Reaction 6 - 25 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 0 Factor 0

Upper 0 Upper 0 Upper 700 Speed 0

Calibration

Request

Rule Two point Linear

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

Order information Cat. No. 1 0441 .. .. …

Notes

1. Please refer to the package insert for Alkaline Phosphatase FS IFCC 37°C 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 16: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

December 2006/2

Page 17: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

April 2006/2

Gamma GT FS (Szasz mod.) Mindray BS300

Parameters

No # Test GGT Method Kinetic Direction Ascend

Unit U/l Decimals 1 Prim. Wave 405 Sec Wave 700

Sample Vol 8 R1 Vol. 200 R2 Vol. 50 Line Limit 20

Response

Incubation 25 Antigen Check Antigen Lower 0 Full Name Gamma GT

Reaction 6 - 21 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 0 Factor 0

Upper 0 Upper 0 Upper 570 Speed 0

Calibration

Request

Rule Two point Linear

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

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.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 18: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

April 2006/2

Glucose GOD FS Mindray BS300

Parameters

No # Test GLUC Method Endpoint Direction Ascend

Unit mg/dl Decimals 1 Prim. Wave 510 Sec Wave 700

Sample Vol 3 R1 Vol. 250 R2 Vol. 0 Line Limit 20

Response

Incubation 0 Antigen Check Antigen Lower 0 Full Name Glucose

Reaction 0 - 25 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 1 Factor 0

Upper 0 Upper 0 Upper 400 Speed 0

Calibration

Request

Rule Two point Linear

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

Order information Cat. No. 1 2500 .. .. …

Notes

1. Please refer to the package insert for Glucose GOD 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 19: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

January 2009/3

oneHbA1c FS Mindray BS300

Parameters

No # Test HbA1c Method Endpoint Direction Ascend

Unit # Decimals 2 Prim. Wave 670 Sec Wave 0

Sample Vol 4 R1 Vol. 180 R2 Vol. 90 Line Limit 20

Response

Incubation 25 Antigen Check Antigen Lower 0 Full Name HbA1c

Reaction -20 - 25 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower # Factor 0

Upper 0 Upper 0 Upper # Speed 0

Calibration

Request

Rule Spline

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

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.

Page 20: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

April 2006/2

HDL-C Immuno FS Mindray BS300

Parameters

No # Test HDL-C Method Endpoint Direction Ascend

Unit mg/dl Decimals 1 Prim. Wave 630 Sec Wave 700

Sample Vol 3 R1 Vol. 240 R2 Vol. 60 Line Limit 20

Response

Incubation 25 Antigen Check Antigen Lower 0 Full Name HDL-C

Reaction -2 - 25 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 1 Factor 0

Upper 0 Upper 0 Upper 180 Speed 0

Calibration

Request

Rule Two point Linear

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

Order information Cat. No. 1 3521 .. .. …

Notes

1. Please refer to the package insert for HDL-C Immuno 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: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

April 2006/2

Lactate FS Mindray BS300

Parameters

No # Test LACT Method Endpoint Direction Ascend

Unit mg/dl Decimals 1 Prim. Wave 340 Sec Wave 700

Sample Vol 4 R1 Vol. 240 R2 Vol. 60 Line Limit 20

Response

Incubation 25 Antigen Check Antigen Lower 0 Full Name Lactate

Reaction -2 - 25 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 1 Factor 0

Upper 0 Upper 0 Upper 120 Speed 0

Calibration

Request

Rule Two point Linear

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

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.

Page 22: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

April 2006/2

LDH FS DGKC Mindray BS300

Parameters

No # Test LDH DGKC Method Kinetic Direction Descend

Unit U/l Decimals 0 Prim. Wave 340 Sec Wave 405

Sample Vol 7 R1 Vol. 200 R2 Vol. 50 Line Limit 20

Response

Incubation 25 Antigen Check Antigen Lower 0 Full Name LDH DGKC

Reaction 7 - 25 Substrate 2.5 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 0 Factor 0

Upper 0 Upper 0 Upper 2400 Speed 0

Calibration

Request

Rule Two point Linear

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

Order information Cat. No. 1 4201 .. .. …

Notes

1. Please refer to the package insert for LDH FS DGKC 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 23: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

April 2006/2

LDL-C Select FS Mindray BS300

Parameters

No # Test LDL-C Method Endpoint Direction Ascend

Unit mg/dl Decimals 1 Prim. Wave 630 Sec Wave 700

Sample Vol 3 R1 Vol. 240 R2 Vol. 60 Line Limit 20

Response

Incubation 25 Antigen Check Antigen Lower 0 Full Name LDL-C

Reaction -2 - 25 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 1 Factor 0

Upper 0 Upper 0 Upper 400 Speed 0

Calibration

Request

Rule Two point Linear

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

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 24: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

April 2006/2

Lipase DC FS Mindray BS300

Parameters

No # Test LIP Method Kinetic Direction Ascend

Unit U/l Decimals 1 Prim. Wave 578 Sec Wave 700

Sample Vol 5 R1 Vol. 200 R2 Vol. 50 Line Limit 20

Response

Incubation 10 Antigen Check Antigen Lower 0 Full Name Lipase

Reaction 8 - 25 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 0 Factor 0

Upper 0 Upper 0 Upper 300 Speed 0

Calibration

Request

Rule Two point Linear

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

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 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 25: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

November 2008/1

Lp(a) 21 FS Mindray BS300

Parameters

No # Test LPA Method Endpoint Direction Ascend

Unit mg/dL Decimals 1 Prim. Wave 700 Sec Wave 0

Sample Vol 5 R1 Vol. 200 R2 Vol. 100 Line Limit 20

Response

Incubation 25 Antigen Check Antigen Lower 0 Full Name Lp(a)

Reaction 6 - 25 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 3 Factor 0

Upper 0 Upper 0 Upper 130 Speed 0

Calibration

Request

Rule Spline

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user NOTE – TruCal TRUCAL LP(A) 21 Level 1 is not used for Calibration (Only 5 levels including blank allowed )

Order information Cat. No. 1 7139 .. .. …

Notes

1. Please refer to the package insert for Lp(a) 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 26: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

April 2006/2

Magnesium XL FS Mindray BS300

Parameters

No # Test MG Method Endpoint Direction Ascend

Unit mg/dl Decimals 2 Prim. Wave 546 Sec Wave 700

Sample Vol 3 R1 Vol. 250 R2 Vol. 0 Line Limit 20

Response

Incubation 0 Antigen Check Antigen Lower 0 Full Name Magnesium

Reaction 0 - 25 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 0.05 Factor 0

Upper 0 Upper 0 Upper 5.0 Speed 0

Calibration

Request

Rule Two point Linear

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

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.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 27: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

May 2006/2

CRP U-hs Universal (U) application Mindray BS300

Parameters

No # Test CRP U Method Endpoint Direction Ascent

Unit mg/l Decimals 2 Prim. Wave 510 Sec Wave 0

Sample Vol 2.5 R1 Vol. 180 R2 Vol. 180 Line Limit 20

Response

Incubation 1 Antigen Check Antigen Lower 0 Full Name CRP U

Reaction 1 - 14 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 0 Factor 0

Upper 0 Upper 0 Upper 0 Speed 0

Calibration

Request

Rule 5P logitlog

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user NOTE – TruCal CRP U Level 4 is not used for Calibration (Only 5 levels including blank allowed )

Order information Cat. No. 1 7045 .. .. …

Notes

1. Please refer to the package insert for CRP U-hs 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: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

May 2006/2

CRP U-hs High sensitive (hs) application Mindray BS300

Parameters

No # Test CRP hs Method Endpoint Direction Ascent

Unit mg/dl Decimals 2 Prim. Wave 510 Sec Wave 0

Sample Vol 18 R1 Vol. 180 R2 Vol. 180 Line Limit 20

Response

Incubation 1 Antigen Check Antigen Lower 0 Full Name CRP hs

Reaction 1 - 25 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 0 Factor 0

Upper 0 Upper 0 Upper 0 Speed 0

Calibration

Request

Rule 5P logitlog

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user NOTE – TruCal CRP hs Level 4 is not used for Calibration (Only 5 levels including blank allowed )

Order information Cat. No. 1 7045 .. .. …

Notes

1. Please refer to the package insert for CRP U-hs 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 29: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

December 2006/2

Total Protein FS Mindray BS300

Parameters

No # Test TP Method Endpoint Direction Ascend

Unit g/dl Decimals 1 Prim. Wave 546 Sec Wave 0

Sample Vol 6 R1 Vol. 240 R2 Vol. 60 Line Limit 20

Response

Incubation 25 Antigen Check Antigen Lower 0 Full Name Total Protein

Reaction -2 - 25 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 0 Factor 0

Upper 0 Upper 0 Upper 15.0 Speed 0

Calibration

Request

Rule Two point Linear

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

Order information Cat. No. 1 2311 .. .. …

Notes

1. Please refer to the package insert for Toatl 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.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 30: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

December 2006/2

Total Protein UC FS Mindray BS300

Parameters

No # Test TPU Method Endpoint Direction Ascend

Unit mg/l Decimals 0 Prim. Wave 578 Sec Wave 700

Sample Vol 5 R1 Vol. 250 R2 Vol. 0 Line Limit 20

Response

Incubation 0 Antigen Check Antigen Lower 0 Full Name TPU

Reaction 0 - 25 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 20 Factor 0

Upper 0 Upper 0 Upper 300 Speed 0

Calibration

Request

Rule Two point Linear

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

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.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 31: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

April 2006/2

ASAT (GOT) FS (IFCC mod.) Mindray BS300

Parameters

No # Test ASAT Method Kinetic Direction Descend

Unit U/l Decimals 1 Prim. Wave 340 Sec Wave 405

Sample Vol 15 R1 Vol. 200 R2 Vol. 50 Line Limit 20

Response

Incubation 25 Antigen Check Antigen Lower 0 Full Name ASAT

Reaction 6 - 25 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 0 Factor 0

Upper 0 Upper 0 Upper 450 Speed 0

Calibration

Request

Rule Two point Linear

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

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.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 32: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

April 2006/2

ALAT (GPT) FS (IFCC mod.) Mindray BS300

Parameters

No # Test ALAT Method Kinetic Direction Descend

Unit U/l Decimals 1 Prim. Wave 340 Sec Wave 405

Sample Vol 15 R1 Vol. 200 R2 Vol. 50 Line Limit 20

Response

Incubation 25 Antigen Check Antigen Lower 0 Full Name ALAT

Reaction 8 - 23 Substrate 2.5 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 0 Factor 0

Upper 0 Upper 0 Upper 450 Speed 0

Calibration

Request

Rule Two point Linear

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

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.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 33: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

December 2006/2

Triglcerides FS Mindray BS300

Parameters

No # Test TRIG Method Endpoint Direction Ascend

Unit mg/dl Decimals 0 Prim. Wave 510 Sec Wave 700

Sample Vol 3 R1 Vol. 250 R2 Vol. 0 Line Limit 20

Response

Incubation 0 Antigen Check Antigen Lower 0 Full Name Triglycerides

Reaction 0 - 5 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 1 Factor 0

Upper 0 Upper 0 Upper 1000 Speed 0

Calibration

Request

Rule Two point Linear

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

Order information Cat. No. 1 5760 .. .. …

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.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 34: Uric Acid FS TBHBA - Kovalent€¦ · April 2006/2 Uric Acid FS TBHBA Mindray BS300 Parameters No # Test Uric Acid Method Endpoint Direction Ascend Unit mg/dl Decimals 1 Prim

April 2006/2

Urea FS Mindray BS300

Parameters

No # Test Urea Method Kinetic Direction Descend

Unit mg/dl Decimals 1 Prim. Wave 340 Sec Wave 405

Sample Vol 2 R1 Vol. 200 R2 Vol. 50 Line Limit 20

Response

Incubation 25 Antigen Check Antigen Lower 0 Full Name Urea

Reaction 3 - 10 Substrate 0 Upper 0 Print No. #

R1 Blank Mix R Blank Linearity

Lower 0 Lower 0 Lower 2 Factor 0

Upper 0 Upper 0 Upper 300 Speed 0

Calibration

Request

Rule Two point Linear

Replicates 2 Difference 0

Interval 0 Blank Response 0 0

Sensitivity 0 Coeff Difference 0

Correlation 0 Non-Linear SD 0

# entered by the user

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.

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.