⠀䄀唀吀伀䰀夀娀䔀刀 ⴀ 䴀䔀吀刀伀䰀䄀䈀 ㈀㌀ 尩 · Autolyzer / MetroLab 2300...

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April 2006/2 Uric Acid FS TBHBA Autolyzer / MetroLab 2300 *calculated by the instrument # concentration entered by the user ** 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. Test ID Name Brand Units UA-DI Urate DIASYS mg/dl Chemistry Definition Wavelength (nm) Reference values Type Min Max Color Principal 550 M 3.6 8.2 Cal. Life time Bichromatic 0 W 2.3 6.1 0 Days Vols (μl) Times (sec) Limits Sample 4 2nd Reag 300 Low Conc 0.07 1st Reag 200 Incubation 600 High Conc 20 2nd Reag 50 Interval 0 Consumption 0.3 Reference Single point Direction Single point Factor * Increase Multipoint Standard # Decrease Detail Calculation Blank Abs Factor Calculation Slope 1 Minimum 0 Provisory Replacement Intercept 0 Maximum 10 Average Discard Vol (μl) Additional Shake Nomencl ** 1st Reag 0 Blank (Color Meth) Decimals 2 2nd Reag 0 In Cuvette Temperature 37 Batch Dilution 1: 1 Dilution Exclusive

Transcript of ⠀䄀唀吀伀䰀夀娀䔀刀 ⴀ 䴀䔀吀刀伀䰀䄀䈀 ㈀㌀ 尩 · Autolyzer / MetroLab 2300...

  • April 2006/2

    Uric Acid FS TBHBA Autolyzer / MetroLab 2300

    *calculated by the instrument # concentration entered by the user ** 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.

    Test ID Name Brand Units

    UA-DI Urate DIASYS mg/dl

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max Color

    Principal 550 M 3.6 8.2

    Cal. Life time

    Bichromatic 0 W 2.3 6.1 0 Days

    Vols (µl) Times (sec) Limits

    Sample 4 2nd Reag 300 Low Conc 0.07

    1st Reag 200 Incubation 600 High Conc 20

    2nd Reag 50 Interval 0 Consumption 0.3

    Reference Single point Direction

    Single point Factor * Increase

    Multipoint Standard # Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum 0 Provisory

    Replacement

    Intercept 0 Maximum 10 Average

    Discard Vol (µl) Additional Shake

    Nomencl **

    1st Reag 0 Blank (Color Meth)

    Decimals 2

    2nd Reag 0 In Cuvette

    Temperature 37 Batch

    Dilution

    1: 1

    Dilution Exclusive

  • April 2006/2

    Albumin FS Autolyzer / MetroLab 2300

    *calculated by the instrument # concentration entered by the user ** entered by the user

    Order information Cat. No. 1 0220 .. .. …

    Notes

    1. Please refer to the package insert for Albumin FS for detailed information about the test on the following:

    Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

    2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

    3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

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

    Test ID Name Brand Units

    ALBU-DI ALBUMIN DIASYS g/dl

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max Color

    Principal 550 M 3.5 5.2

    Cal. Life time

    Bichromatic 0 W 3.5 5.2 0 Days

    Vols (µl) Times (sec) Limits

    Sample 3 2nd Reag 0 Low Conc 0

    1st Reag 300 Incubation 300 High Conc 6

    2nd Reag 0 Interval 0 Consumption 0.3

    Reference Single point Direction

    Single point Factor * Increase

    Multipoint Standard # Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum 0 Provisory

    Replacement

    Intercept 0 Maximum 0.35 Average

    Discard Vol (µl) Additional Shake

    Nomencl **

    1st Reag 0 Blank (Color Meth)

    Decimals 2

    2nd Reag 0 In Cuvette

    Temperature 37 Batch

    Dilution

    1: 1

    Dilution Exclusive

  • April 2006/2

    Amylase CC FS Autolyzer / MetroLab 2300

    *calculated by the instrument # concentration entered by the user ** 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.

    Test ID Name Brand Units

    AMY Amylase DIASYS U/l

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max Fast Kinetics

    Principal 405 M 0 215

    Cal. Life time

    Bichromatic 0 W 0 215 0 Days

    Vols (µl) Times (sec) Limits

    Sample 4 2nd Reag 60 Low Conc 3

    1st Reag 200 Incubation 120 High Conc 4827

    2nd Reag 50 Interval 0 Consumption 0.35

    Reference Single point Direction

    Single point Factor * Increase

    Multipoint Standard # Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum 0 Provisory

    Replacement

    Intercept 0 Maximum 10 Average

    Discard Vol (µl) Additional Shake

    Nomencl **

    1st Reag 0 Blank (Color Meth)

    Decimals 0

    2nd Reag 0 In Cuvette

    Temperature 37 Batch

    Dilution

    1: 1

    Dilution Exclusive

  • April 2007/3

    Bilirubin Auto Direct FS Autolyzer / MetroLab 2300

    *calculated by the instrument # concentration entered by the user ** 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.

    Test ID Name Brand Units

    Bili D Bili D DIASYS mg/dl

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max Endpoint

    Principal 550 M ** **

    Cal. Life time

    Bichromatic 0 W ** ** 0 Days

    Vols (µl) Times (sec) Limits

    Sample 24 2nd Reag 180 Low Conc 0.1

    1st Reag 200 Incubation 300 High Conc 10

    2nd Reag 50 Kinetics2 0 Consumption 0

    Reference Single point Direction

    Single point Factor * Increase

    Multipoint Standard # Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum -0.5 Provisory

    Replacement

    Intercept 0 Maximum 10 Average

    Discard Vol (µl) Additional Shake

    Nomencl **

    1st Reag 0 Blank (Color Meth)

    Decimals 2

    2nd Reag 0 In Cuvette

    Temperature 37 Batch

    Dilution

    1: 1

    Dilution Exclusive

  • April 2007/3

    Bilirubin Auto Total FS Autolyzer / MetroLab 2300

    *calculated by the instrument # concentration entered by the user ** 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.

    Test ID Name Brand Units

    Bili T Bili T DIASYS mg/dl

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max Endpoint

    Principal 550 M ** **

    Cal. Life time

    Bichromatic 0 W ** ** 0 Days

    Vols (µl) Times (sec) Limits

    Sample 6 2nd Reag 300 Low Conc 0.07

    1st Reag 200 Incubation 300 High Conc 30

    2nd Reag 50 Kinetics2 0 Consumption 0

    Reference Single point Direction

    Single point Factor * Increase

    Multipoint Standard # Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum 0 Provisory

    Replacement

    Intercept 0 Maximum 10 Average

    Discard Vol (µl) Additional Shake

    Nomencl **

    1st Reag 0 Blank (Color Meth)

    Decimals 2

    2nd Reag 0 In Cuvette

    Temperature 37 Batch

    Dilution

    1: 1

    Dilution Exclusive

  • April 2006/2

    Calcium AS FS Autolyzer / MetroLab 2300

    *calculated by the instrument # concentration entered by the user ** 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.

    Test ID Name Brand Units

    Calc Calcium DIASYS mg/dl

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max Color

    Principal 650 M ** **

    Cal. Life time

    Bichromatic 700 W ** ** 0 Days

    Vols (µl) Times (sec) Limits

    Sample 3 2nd Reag 0 Low Conc 0.04

    1st Reag 300 Incubation 300 High Conc 25

    2nd Reag 0 Interval 0 Consumption 0.3

    Reference Single point Direction

    Single point Factor * Increase

    Multipoint Standard # Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum 0 Provisory

    Replacement

    Intercept 0 Maximum 10 Average

    Discard Vol (µl) Additional Shake

    Nomencl **

    1st Reag 0 Integrity

    Decimals 2

    2nd Reag 0 Blank

    Temperature 37

    Dilution

    1: 1

    Dilution Exclusive

  • January 2008/1

    CK-MB FS Autolyzer / MetroLab 2300 – MONOREAGENT APPLICATION

    *calculated by the instrument # concentration entered by the user ** entered by the user

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

    Notes

    1. Please refer to the package insert for CK-MB FS for detailed information about the test on the following:

    Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

    2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

    3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

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

    Test ID Name Brand Units

    CK-MB CK-MB DIASYS U/l

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max Fast Kinetics

    Principal 340 M 0 24

    Cal. Life time

    Bichromatic 0 W 0 24 0 Days

    Vols (µl) Times (sec) Limits

    Sample 8 2nd Reag 0 Low Conc 2

    1st Reag 200 Incubation 300 High Conc 1032

    2nd Reag 0 Interval 0 Consumption 0.125

    Reference Single point Direction

    Single point Factor * Increase

    Multipoint Standard # Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum 0 Provisory

    Replacement

    Intercept 0 Maximum 10 Average

    Discard Vol (µl) Additional Shake

    Nomencl **

    1st Reag 0 Blank (Color Meth)

    Decimals 1

    2nd Reag 0 In Cuvette

    Temperature 37 Batch

    Dilution

    1: 1

    Dilution Exclusive

  • January 2008/1

    CK-NAC FS Autolyzer / MetroLab 2300

    *calculated by the instrument # concentration entered by the user ** entered by the user

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

    Notes

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

    Test ID Name Brand Units

    CK-DI CK-NAC DIASYS U/l

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max Fast Kinetics

    Principal 340 M 24 195

    Cal. Life time

    Bichromatic 0 W 24 170 0 Days

    Vols (µl) Times (sec) Limits

    Sample 10 2nd Reag 180 Low Conc 1

    1st Reag 200 Incubation 120 High Conc 1032

    2nd Reag 50 Interval 0 Consumption 0.25

    Reference Single point Direction

    Single point Factor * Increase

    Multipoint Standard # Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum 0 Provisory

    Replacement

    Intercept 0 Maximum 10 Average

    Discard Vol (µl) Additional Shake

    Nomencl **

    1st Reag 0 Blank (Color Meth)

    Decimals 1

    2nd Reag 0 In Cuvette

    Temperature 37 Batch

    Dilution

    1: 1

    Dilution Exclusive

  • April 2006/2

    Chloride FS Autolyzer / MetroLab 2300

    *calculated by the instrument # concentration entered by the user ** 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.

    Test ID Name Brand Units

    CL CHLORIDE DIASYS mmol/l

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max Color

    Principal 450 M ** **

    Cal. Life time

    Bichromatic 0 W ** ** 0 Days

    Vols (µl) Times (sec) Limits

    Sample 3 2nd Reag 0 Low Conc 1

    1st Reag 300 Incubation 300 High Conc 130

    2nd Reag 0 Kinetics2 0 Consumption 0

    Reference Single point Direction

    Single point Factor * Increase

    Multipoint Standard # Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum 0 Provisory

    Replacement

    Intercept 0 Maximum 10 Average

    Discard Vol (µl) Additional Shake

    Nomencl **

    1st Reag 0 Blank (Color Meth)

    Decimals 1

    2nd Reag 0 In Cuvette

    Temperature 37 Batch

    Dilution

    1: 1

    Dilution Exclusive

  • April 2006/2

    Cholesterol FS Autolyzer / MetroLab 2300

    *calculated by the instrument # concentration entered by the user ** 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.

    Test ID Name Brand Units

    CHOL-DI CHOL DIASYS mg/dl

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max Color

    Principal 505 M ** **

    Cal. Life time

    Bichromatic 0 W ** ** 0 Days

    Vols (µl) Times (sec) Limits

    Sample 3 2nd Reag 0 Low Conc 3

    1st Reag 300 Incubation 600 High Conc 750

    2nd Reag 0 Interval 0 Consumption 0

    Reference Single point Direction

    Single point Factor * Increase

    Multipoint Standard # Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum 0 Provisory

    Replacement

    Intercept 0 Maximum 0.3 Average

    Discard Vol (µl) Additional Shake

    Nomencl **

    1st Reag 0 Blank (Color Meth)

    Decimals 1

    2nd Reag 0 In Cuvette

    Temperature 37 Batch

    Dilution

    1: 1

    Dilution Exclusive

  • June 2009/1

    Cholinesterase FS Autolyzer / MetroLab 2300

    *calculated by the instrument # concentration entered by the user ** entered by the user

    Order information Cat. No. 1 1401 .. .. …

    Notes

    1. Please refer to the package insert for Alkaline 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.

    Test ID Name Brand Units

    CHE-DI CHE DIASYS U/l

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max Fast Kinetics

    Principal 405 M 4620 11500

    Cal. Life time

    Bichromatic 0 W 3930 10800 0 Days

    Vols (µl) Times (sec) Limits

    Sample 4 2nd Reag 180 Low Conc 50

    1st Reag 200 Incubation 120 High Conc 20000

    2nd Reag 50 Interval 0 Consumption 0.3

    Reference Single point Direction

    Single point Factor 65692 Increase

    Multipoint Standard 0 Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum -1 Provisory

    Replacement

    Intercept 0 Maximum 10 Average

    Discard Vol (µl) Additional Shake

    Nomencl

    1st Reag 0 Blank (Color Meth)

    Decimals 0

    2nd Reag 0 In Cuvette

    Temperature 37 Batch

    Dilution

    1: 1

    Dilution Exclusive

  • April 2008/3

    Creatinine FS Autolyzer / MetroLab 2300 – MONOREAGENT APPLICATION

    *calculated by the instrument # concentration entered by the user ** 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.

    Test ID Name Brand Units

    CREA-DI CREAT DIASYS mg/dl

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max 2-Pt Kinetics

    Principal 505 M 0.9 1.3

    Cal. Life time

    Bichromatic 0 W 0.6 1.1 0 Days

    Vols (µl) Times (sec) Limits

    Sample 10 2nd Reag 0 Low Conc 0.2

    1st Reag 200 Incubation 60 High Conc 15

    2nd Reag 0 Interval 120 Consumption 0.3

    Reference Single point Direction

    Single point Factor * Increase

    Multipoint Standard # Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum -0.5 Provisory

    Replacement

    Intercept 0 Maximum 0.5 Average

    Discard Vol (µl) Additional Shake

    Nomencl **

    1st Reag 0 Blank (Color Meth)

    Decimals 2

    2nd Reag 0 In Cuvette

    Temperature 37 Batch

    Dilution

    1: 1

    Dilution Exclusive

  • April 2008/3

    Creatinine FS – Compensated Method Autolyzer / MetroLab 2300 – MONOREAGENT APPLICATION

    *calculated by the instrument # concentration entered by the user ** entered by the user

    Compensated Method

    To use the Creatinine FS Compensated Method on the Autolyzer the Calculation Intercept must be changed as follows; When the units are mg/dL

    Calculation Intercept - 0.3

    When the units are µmol/L

    Calculation Intercept - 27

    Note: Ensure that when using the Creatinine Compensated Method the relevant assigned Calibrator value is selected **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

    Test ID Name Brand Units

    CREA-DI CREAT DIASYS mg/dl

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max 2-Pt Kinetics

    Principal 505 M 0.9 1.3

    Cal. Life time

    Bichromatic 0 W 0.6 1.1 0 Days

    Vols (µl) Times (sec) Limits

    Sample 10 2nd Reag 0 Low Conc 0.2

    1st Reag 200 Incubation 60 High Conc 15

    2nd Reag 0 Interval 120 Consumption 0.3

    Reference Single point Direction

    Single point Factor * Increase

    Multipoint Standard # Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum -0.5 Provisory

    Replacement

    Intercept -0.3 Maximum 0.5 Average

    Discard Vol (µl) Additional Shake

    Nomencl **

    1st Reag 0 Blank (Color Meth)

    Decimals 2

    2nd Reag 0 In Cuvette

    Temperature 37 Batch

    Dilution

    1: 1

    Dilution Exclusive

  • April 2006/2

    Iron FS Ferene Autolyzer / MetroLab 2300

    *calculated by the instrument # concentration entered by the user ** 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.

    Test ID Name Brand Units

    IRON Iron DIASYS µg/dl

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max Color

    Principal 600 M ** **

    Cal. Life time

    Bichromatic 0 W ** ** 0 Days

    Vols (µl) Times (sec) Limits

    Sample 20 2nd Reag 120 Low Conc 2

    1st Reag 200 Incubation 600 High Conc 1000

    2nd Reag 50 Kinetics2 0 Consumption 0.3

    Reference Single point Direction

    Single point Factor * Increase

    Multipoint Standard # Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum 0 Provisory

    Replacement

    Intercept 0 Maximum 10 Average

    Discard Vol (µl) Additional Shake

    Nomencl **

    1st Reag 0 Blank (Color Meth)

    Decimals 2

    2nd Reag 0 In Cuvette

    Temperature 37 Batch

    Dilution

    1: 1

    Dilution Exclusive

  • April 2006/2

    Alkaline Phosphatase FS IFCC 37°C Autolyzer / MetroLab 2300

    *calculated by the instrument # concentration entered by the user ** 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.

    Test ID Name Brand Units

    ALP-DI ALP DIASYS U/l

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max Fast Kinetics

    Principal 405 M 53 128

    Cal. Life time

    Bichromatic 0 W 42 98 0 Days

    Vols (µl) Times (sec) Limits

    Sample 4 2nd Reag 60 Low Conc 2

    1st Reag 200 Incubation 60 High Conc 858

    2nd Reag 50 Interval 0 Consumption 0.25

    Reference Single point Direction

    Single point Factor * Increase

    Multipoint Standard # Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum 0 Provisory

    Replacement

    Intercept 0 Maximum 10 Average

    Discard Vol (µl) Additional Shake

    Nomencl **

    1st Reag 0 Blank (Color Meth)

    Decimals 1

    2nd Reag 0 In Cuvette

    Temperature 37 Batch

    Dilution

    1: 1

    Dilution Exclusive

  • April 2006/2

    Gamma GT FS (Szasz mod.) Autolyzer / MetroLab 2300

    *calculated by the instrument # concentration entered by the user ** 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.

    Test ID Name Brand Units

    GGT GGT DIASYS U/l

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max Fast Kinetics

    Principal 405 M 0 55

    Cal. Life time

    Bichromatic 0 W 0 38 0 Days

    Vols (µl) Times (sec) Limits

    Sample 20 2nd Reag 60 Low Conc 2

    1st Reag 200 Incubation 60 High Conc 284

    2nd Reag 50 Interval 0 Consumption 0.2

    Reference Single point Direction

    Single point Factor * Increase

    Multipoint Standard # Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum 0 Provisory

    Replacement

    Intercept 0 Maximum 10 Average

    Discard Vol (µl) Additional Shake

    Nomencl **

    1st Reag 0 Blank (Color Meth)

    Decimals 2

    2nd Reag 0 In Cuvette

    Temperature 37 Batch

    Dilution

    1: 1

    Dilution Exclusive

  • April 2006/2

    Glucose GOD FS Autolyzer / MetroLab 2300

    *calculated by the instrument # concentration entered by the user ** 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.

    Test ID Name Brand Units

    GLUC-DI Glucose DIASYS mg/dl

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max Color

    Principal 550 M ** **

    Cal. Life time

    Bichromatic 0 W ** ** 0 Days

    Vols (µl) Times (sec) Limits

    Sample 3 2nd Reag 0 Low Conc 1

    1st Reag 300 Incubation 600 High Conc 400

    2nd Reag 0 Interval 0 Consumption 0

    Reference Single point Direction

    Single point Factor * Increase

    Multipoint Standard # Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum 0 Provisory

    Replacement

    Intercept 0 Maximum 0.3 Average

    Discard Vol (µl) Additional Shake

    Nomencl **

    1st Reag 0 Blank (Color Meth)

    Decimals 1

    2nd Reag 0 In Cuvette

    Temperature 37 Batch

    Dilution

    1: 1

    Dilution Exclusive

  • January 2009/4

    oneHbA1c FS Autolyzer / MetroLab 2300

    *calculated by the instrument # concentration entered by the user ** 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.

    Test ID Name Brand Units

    HbA1c HbA1c DIASYS **

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max Color

    Principal 650 M ** **

    Cal. Life time

    Bichromatic 0 W ** ** 0 Days

    Vols (µl) Times (sec) Limits

    Sample 4 2nd Reag 300 Low Conc #

    1st Reag 180 Incubation 300 High Conc #

    2nd Reag 90 Interval 0 Consumption 0.3

    Reference Single point Direction

    Single point Factor 1 Increase

    Multipoint Standard 0 Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum 0 Provisory

    Replacement

    Intercept 0 Maximum 10 Average

    Discard Vol (µl) Additional Shake

    Nomencl **

    1st Reag 0 Blank (Color Meth)

    Decimals 2

    2nd Reag 0 In Cuvette

    Temperature 37 Batch

    Dilution

    1: 1

    Dilution Exclusive

  • January 2010/1

    HDL-C Immuno FS Autolyzer / MetroLab 2300

    *calculated by the instrument # concentration entered by the user ** 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.

    Test ID Name Brand Units

    HDL HDL DIASYS mg/dl

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max Endpoint

    Principal 600 M ** **

    Cal. Life time

    Bichromatic 700 W ** ** 0 Days

    Vols (µl) Times (sec) Limits

    Sample 3 2nd Reag 300 Low Conc 1

    1st Reag 240 Incubation 300 High Conc 180

    2nd Reag 60 Kinetics2 0 Consumption 0

    Reference Single point Direction

    Single point Factor * Increase

    Multipoint Standard # Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum 0 Provisory

    Replacement

    Intercept 0 Maximum 10 Average

    Discard Vol (µl) Additional Shake

    Nomencl **

    1st Reag 0 Blank (Color Meth)

    Decimals 1

    2nd Reag 0 In Cuvette

    Temperature 37 Batch

    Dilution

    1: 1

    Dilution Exclusive

  • April 2006/2

    LDH FS DGKC Autolyzer / MetroLab 2300 – MONOREAGENT APPLICATION

    *calculated by the instrument # concentration entered by the user ** 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.

    Test ID Name Brand Units

    LDH LDH DIASYS U/l

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max Fast Kinetics

    Principal 340 M ** **

    Cal. Life time

    Bichromatic 0 W ** ** 0 Days

    Vols (µl) Times (sec) Limits

    Sample 3 2nd Reag 0 Low Conc 5

    1st Reag 300 Incubation 60 High Conc 3059

    2nd Reag 0 Interval 0 Consumption 0.15

    Reference Single point Direction

    Single point Factor * Increase

    Multipoint Standard # Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum 0 Provisory

    Replacement

    Intercept 0 Maximum 10 Average

    Discard Vol (µl) Additional Shake

    Nomencl **

    1st Reag 0 Integrity

    Decimals 2

    2nd Reag 0 Blank

    Temperature 37

    Dilution

    1: 1

    Dilution Exclusive

  • September 2008/1

    Lipase DC FS Autolyzer / MetroLab 2300

    *calculated by the instrument # concentration entered by the user ** 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.

    Test ID Name Brand Units

    LIP-DI Lipase DIASYS U/l

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max Fast Kinetics

    Principal 550 M 0 60

    Cal. Life time

    Bichromatic 0 W 0 60 0 Days

    Vols (µl) Times (sec) Limits

    Sample 5 2nd Reag 180 Low Conc 2

    1st Reag 200 Incubation 90 High Conc 300

    2nd Reag 50 Interval 0 Consumption 0.25

    Reference Single point Direction

    Single point Factor * Increase

    Multipoint Standard # Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum 0 Provisory

    Replacement

    Intercept 0 Maximum 100 Average

    Discard Vol (µl) Additional Shake

    Nomencl **

    1st Reag 0 Blank (Color Meth)

    Decimals 1

    2nd Reag 0 In Cuvette

    Temperature 37 Batch

    Dilution

    1: 1

    Dilution Exclusive

  • June 2009/1

    Lp(a) 21 FS Autolyzer / MetroLab 2300

    *calculated by the instrument # concentration entered by the user ** entered by the user

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

    Notes

    1. Please refer to the package insert for Lp(a) 21 FS for detailed information about the test on the following:

    Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

    2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

    3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

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

    Test ID Name Brand Units

    LPA-DI Lp(a) DIASYS mg/dl

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max 2-Pt Kinetics

    Principal 700 M 0 30

    Cal. Life time

    Bichromatic 0 W 0 30 0 Days

    Vols (µl) Times (sec) Limits

    Sample 5 2nd Reag 0 Low Conc 3

    1st Reag 200 Incubation 600 High Conc 130

    2nd Reag 100 Interval 240 Consumption 0.3

    Reference Single point Direction

    Single point Factor * Increase

    Multipoint Standard # Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum 0 Provisory

    Replacement

    Intercept 0 Maximum 1.0 Average

    Discard Vol (µl) Additional Shake

    Nomencl **

    1st Reag 0 Blank (Color Meth)

    Decimals 1

    2nd Reag 0 In Cuvette

    Temperature 37 Batch

    Dilution

    1: 1

    Dilution Exclusive

  • April 2006/2

    Magnesium XL FS Autolyzer / MetroLab 2300

    *calculated by the instrument # concentration entered by the user ** 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.

    Test ID Name Brand Units

    MAG-DI Mag DIASYS mg/dl

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max Color

    Principal 550 M 1.8 2.6

    Cal. Life time

    Bichromatic 0 W 1.8 2.6 0 Days

    Vols (µl) Times (sec) Limits

    Sample 3 2nd Reag 0 Low Conc 0

    1st Reag 300 Incubation 300 High Conc 5

    2nd Reag 0 Interval 0 Consumption 0.3

    Reference Single point Direction

    Single point Factor * Increase

    Multipoint Standard # Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum 0 Provisory

    Replacement

    Intercept 0 Maximum 10 Average

    Discard Vol (µl) Additional Shake

    Nomencl **

    1st Reag 0 Blank (Color Meth)

    Decimals 2

    2nd Reag 0 In Cuvette

    Temperature 37 Batch

    Dilution

    1: 1

    Dilution Exclusive

  • May 2010/1

    CRP U-hs High sensitive (hs) application Autolyzer / MetroLab 2300

    *calculated by the instrument # concentration entered by the user ** entered by the user

    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.

    Test ID Name Brand Units

    CRP CRP DIASYS mg/l

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max 2-Pt Kinetics

    Principal 505 M 0 5

    Cal. Life time

    Bichromatic 0 W 0 5 0 Days

    Vols (µl) Times (sec) Limits

    Sample 15 2nd Reag 0 Low Conc 0.05

    1st Reag 150 Incubation 600 High Conc 20.0

    2nd Reag 150 Interval 240 Consumption 0.3

    Reference Single point Direction

    Single point Factor * Increase

    Multipoint Standard # Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum 0 Provisory

    Replacement

    Intercept 0 Maximum 1.0 Average

    Discard Vol (µl) Additional Shake

    Nomencl **

    1st Reag 0 Blank (Color Meth)

    Decimals 2

    2nd Reag 0 In Cuvette

    Temperature 37 Batch

    Dilution

    1: 1

    Dilution Exclusive

  • April 2006/2

    Total Protein FS Autolyzer / MetroLab 2300 – MONOREAGENT APPLICATION

    *calculated by the instrument # concentration entered by the user ** entered by the user

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

    Notes

    1. Please refer to the package insert for Total Protein FS for detailed information about the test on the following:

    Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

    2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

    3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

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

    Test ID Name Brand Units

    TP-DI TPROT DIASYS g/dl

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max Color

    Principal 550 M ** **

    Cal. Life time

    Bichromatic 0 W ** ** 0 Days

    Vols (µl) Times (sec) Limits

    Sample 4 2nd Reag 0 Low Conc 0.05

    1st Reag 200 Incubation 300 High Conc 15

    2nd Reag 0 Kinetics2 0 Consumption 0

    Reference Single point Direction

    Single point Factor * Increase

    Multipoint Standard # Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum 0 Provisory

    Replacement

    Intercept 0 Maximum 0.2 Average

    Discard Vol (µl) Additional Shake

    Nomencl **

    1st Reag 0 Blank (Color Meth)

    Decimals 2

    2nd Reag 0 In Cuvette

    Temperature 37 Batch

    Dilution

    1: 1

    Dilution Exclusive

  • April 2006/2

    ASAT (GOT) FS (IFCC mod.) Autolyzer / MetroLab 2300 – MONOREAGENT APPLICATION

    *calculated by the instrument # concentration entered by the user ** 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.

    Test ID Name Brand Units

    ASAT ASAT DIASYS U/l

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max Fast Kinetics

    Principal 340 M ** **

    Cal. Life time

    Bichromatic 0 W ** ** 0 Days

    Vols (µl) Times (sec) Limits

    Sample 30 2nd Reag 0 Low Conc 2

    1st Reag 300 Incubation 60 High Conc 349

    2nd Reag 0 Interval 0 Consumption 0.16

    Reference Single point Direction

    Single point Factor * Increase

    Multipoint Standard # Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum 0 Provisory

    Replacement

    Intercept 0 Maximum 10 Average

    Discard Vol (µl) Additional Shake

    Nomencl **

    1st Reag 0 Integrity

    Decimals 2

    2nd Reag 0 Blank

    Temperature 37

    Dilution

    1: 1

    Dilution Exclusive

  • April 2006/2

    ALAT (GPT) FS (IFCC mod.) Autolyzer / MetroLab 2300 – MONOREAGENT APPLICATION

    *calculated by the instrument # concentration entered by the user ** 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.

    Test ID Name Brand Units

    ALAT ALAT DIASYS U/l

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max Fast Kinetics

    Principal 340 M ** **

    Cal. Life time

    Bichromatic 0 W ** ** 0 Days

    Vols (µl) Times (sec) Limits

    Sample 30 2nd Reag 0 Low Conc 4

    1st Reag 300 Incubation 60 High Conc 349

    2nd Reag 0 Interval 0 Consumption 0.16

    Reference Single point Direction

    Single point Factor * Increase

    Multipoint Standard # Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum 0 Provisory

    Replacement

    Intercept 0 Maximum 10 Average

    Discard Vol (µl) Additional Shake

    Nomencl **

    1st Reag 0 Integrity

    Decimals 2

    2nd Reag 0 Blank

    Temperature 37

    Dilution

    1: 1

    Dilution Exclusive

  • April 2006/2

    Triglycerides FS Autolyzer / MetroLab 2300

    *calculated by the instrument # concentration entered by the user ** entered by the user

    Order information Cat. No. 1 5710 .. .. …

    Notes

    1. Please refer to the package insert for Triglycerides FS for detailed information about the test on the following:

    Clinical Relevance, Method and Principle, Composition and Stability of the Reagents, Specimens, Calibrators and Controls, Performance Characteristics regarding Measuring Range / Specificity/Interferences / Sensitivity/Limit of Detection / Precision (Reproducibility, Repeatability) / Method Comparison / Reference Ranges / Literature

    2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided.

    3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

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

    Test ID Name Brand Units

    TRIG-DI TRIG DIASYS mg/dl

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max Color

    Principal 550 M ** **

    Cal. Life time

    Bichromatic 0 W ** ** 0 Days

    Vols (µl) Times (sec) Limits

    Sample 3 2nd Reag 0 Low Conc 1

    1st Reag 300 Incubation 600 High Conc 1000

    2nd Reag 0 Interval 0 Consumption 0

    Reference Single point Direction

    Single point Factor * Increase

    Multipoint Standard # Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum 0 Provisory

    Replacement

    Intercept 0 Maximum 0.3 Average

    Discard Vol (µl) Additional Shake

    Nomencl **

    1st Reag 0 Blank (Color Meth)

    Decimals 1

    2nd Reag 0 In Cuvette

    Temperature 37 Batch

    Dilution

    1: 1

    Dilution Exclusive

  • April 2006/2

    Urea FS Autolyzer / MetroLab 2300 – MONOREAGENT APPLICATION

    *calculated by the instrument # concentration entered by the user ** 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.

    Test ID Name Brand Units

    Urea Urea DIASYS mg/dl

    Chemistry

    Definition

    Wavelength (nm) Reference values Type

    Min Max Fast Kinetics

    Principal 340 M ** **

    Cal. Life time

    Bichromatic 0 W ** ** 0 Days

    Vols (µl) Times (sec) Limits

    Sample 3 2nd Reag 0 Low Conc 2

    1st Reag 300 Incubation 40 High Conc 300

    2nd Reag 0 Interval 0 Consumption 1.00

    Reference Single point Direction

    Single point Factor * Increase

    Multipoint Standard # Decrease

    Detail

    Calculation Blank Abs Factor Calculation

    Slope 1 Minimum 0 Provisory

    Replacement

    Intercept 0 Maximum 10 Average

    Discard Vol (µl) Additional Shake

    Nomencl **

    1st Reag 0 Integrity

    Decimals 1

    2nd Reag 0 Blank

    Temperature 37

    Dilution

    1: 1

    Dilution Exclusive