URIC ACID FS TBHBA - KovalentDiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany...
41
July 2009/1 ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters Name UA Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version Reaction definition Reaction Mode Endpoint Up Primary Wavelength 524 Secondary Wavelength 700 Last required measrement 33 Absorbance range 0.000 – 2.500 Sample blank type Same empty cuvette Blank Assay Main Read points 31 - 33 Flex Read points 0 - 0 Raed points correction 0 - 0 Blank Read points 14 - 16 Reagent/Sample Reagent UA Reagent Volume R1 160 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 40 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0 Dilution name Std Dil 1 Dil 2 Sample volume 3.5 0.0 0.0 Vol diluted sample 0.0 0.0 0.0 Diluent volume 0 0 0 Water volume 0 0 0 Diluton factor Validation Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance Linearity Kinetic % Maximum Abs deviation 0.000 Calibration parameters Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.000 – 0.000 Cal Level Conc Sample Vol BLK 0.00 3.5 Cal 1 * 3.5 Linear Range 0.07 – 20.0 Conc Units mg/dl Decimal Places 1 Correlation Factor 1.000 Intercept 0.000 #) Data entry by the user *) Enter calibration or standard value and position **) Factor to be checked by a calibration serum URIC ACID FS TBHBA Order information Cat. No. 1 3021 .. .. … Notes 1. Please refer to the package insert for Uric Acid FS TBHBA for detailed information about the test on the following: Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding - Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison Reference Ranges Literature 2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided. 3. Manufactured by DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
Transcript of URIC ACID FS TBHBA - KovalentDiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany...
July 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name UA Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Endpoint Up Primary Wavelength 524 Secondary Wavelength 700 Last required measrement 33 Absorbance range 0.000 – 2.500 Sample blank type Same empty cuvette Blank Assay Main Read points 31 - 33 Flex Read points 0 - 0 Raed points correction 0 - 0 Blank Read points 14 - 16
Reagent/Sample
Reagent UA Reagent Volume R1 160 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 40 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 3.5 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance Linearity Kinetic % Maximum Abs deviation 0.000
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.000 – 0.000
Cal Level Conc Sample Vol
BLK 0.00 3.5
Cal 1 * 3.5
Linear Range 0.07 – 20.0 Conc Units mg/dl Decimal Places 1 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position **) Factor to be checked by a calibration serum
URIC ACID FS TBHBA Order information
Cat. No. 1 3021 .. .. …
Notes
1. Please refer to the package insert for Uric Acid FS TBHBA for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least one
month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
June 2008/1
PROTOCOLO ARCHITECT General Parameters
Name ALB Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Endpoint Up Primary Wavelength 572 Secondary Wavelength 700 Last required measrement 33 Absorbance range -0.500 – 2.500 Sample blank type Same empty cuvette Blank Assay Main Read points 31 - 33 Flex Read points 0 - 0 Raed points correction 0 - 0 Blank Read points 0 - 0
Reagent/Sample
Reagent ALB Reagent Volume R1 200 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 0 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 2.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor 0 0 0
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance Linearity Kinetic % Maximum Abs deviation 0.000
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.00 – 0.00
Cal Level Conc Sample Vol
BLK 0.00 2.0
Cal 1 * 2.0
Cal 2
Cal 3
Cal 4
Cal 5
Linear Range 0.2 – 6.0 Conc Units g/dl Decimal Places 1 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position
ALBUMIN FS Notas: 1. Por favor, recorra a bula do produto para informações detalhadas sobre os seguintes testes: Relevância clínica Método e Princípio Composição e Estabilidade dos Reagentes Amostras Calibradores e Controles Desempenho e Características considerando: - Faixa de medição - Especificidade/Interferentes - Sensibilidade/Limite de Detecção - Precisão (Reprodutibilidade, Repetibilidade) - Comparação de método - Valores de referência - Literatura 2. A estabilidade do reagente a bordo do analisador é pelo menos um mês contanto que sejam evitadas a contaminação e a evaporação 3. Fabricado por: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
July 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name Amylase Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Rate Up Primary Wavelength 404 Secondary Wavelength 660 Last required measrement 30 Absorbance range -0.500 – 2.500 Sample blank type Same empty cuvette Blank Assay Main Read points 22 - 30 Flex Read points 20 - 23 Read points correction 0 - 0 Blank Read points 0 - 0
Reagent/Sample
Reagent Amylase Reagent Volume R1 160 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 40 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 4.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor 0 0 0
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance 0 Linearity Kinetic % 15 Maximum Abs deviation
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.00 – 0.00
Cal Level Conc Sample Vol
BLK 0.00 4.0
Cal 1 * 4.0
Cal 2
Cal 3
Cal 4
Cal 5
Linear Range # – # Conc Units U/l Decimal Places 0 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position
-AMYLASE CC FS 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 6 weeks
provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
July 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name APOA Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Endpoint Up Primary Wavelength 572 Secondary Wavelength 0 Last required measrement 33 Absorbance range 0.000 – 2.500 Sample blank type Same empty cuvette Blank Assay Main Read points 33 - 33 Flex Read points 0 - 0 Raed points correction 0 - 0 Blank Read points 16 - 16
Reagent/Sample
Reagent APOA Reagent Volume R1 250 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 50 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 2.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance Linearity Kinetic % Maximum Abs deviation 0.000
Calibration parameters
Calibration Method Logit/Log 4P Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.000 – 0.000
Cal Level Conc Sample Vol
BLK 0.00 2.0
Cal 1 * 2.0
Cal 2 * 2.0
Cal 3 * 2.0
Cal 4
Cal 5
Linear Range 0.2 – 250.0 Conc Units mg/dl Decimal Places 0 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position **) Factor to be checked by a calibration serum
APOLIPOPROTEIN A1 FS Order information
Cat. No. 1 7102 .. .. …
Notes
1. Please refer to the package insert for Apolipoprotein A1 FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least one
month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
July 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name APOB Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Endpoint Up Primary Wavelength 340 Secondary Wavelength 0 Last required measrement 33 Absorbance range 0.000 – 2.500 Sample blank type Same empty cuvette Blank Assay Main Read points 33 - 33 Flex Read points 0 - 0 Raed points correction 0 - 0 Blank Read points 16 - 16
Reagent/Sample
Reagent APOB Reagent Volume R1 250 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 50 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 2.5 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance Linearity Kinetic % Maximum Abs deviation 0.000
Calibration parameters
Calibration Method Logit/Log 4P Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.000 – 0.000
Cal Level Conc Sample Vol
BLK 0.00 2.5
Cal 1 * 2.5
Cal 2 * 2.5
Cal 3 * 2.5
Cal 4
Cal 5
Linear Range 0.2 – 250.0 Conc Units mg/dl Decimal Places 0 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position **) Factor to be checked by a calibration serum
APOLIPOPROTEIN B FS Order information
Cat. No. 1 7112 .. .. …
Notes
1. Please refer to the package insert for Apolipoprotein B FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least one
month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
July 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name CO2 Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Rate Down Primary Wavelength 412 Secondary Wavelength 500 Last required measrement 29 Absorbance range -0.500 – 2.500 Sample blank type Same empty cuvette Blank Assay Main Read points 5 - 29 Flex Read points 0 - 0 Read points correction 0 - 0 Blank Read points 0 - 0
Reagent/Sample
Reagent CO2 Reagent Volume R1 300 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 0 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 3.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor 0 0 0
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance 0 Linearity Kinetic % 20 Maximum Abs deviation
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.00 – 0.00
Cal Level Conc Sample Vol
BLK 0.00 3.0
Cal 1 * 3.0
Cal 2
Cal 3
Cal 4
Cal 5
Linear Range # – # Conc Units mmol/l Decimal Places 1 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position
BICARBONATE FS Order information
Cat. No. 1 0950 .. .. …
Notes
1. Please refer to the package insert for Bicarbonate FS for detailed
information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is 6 weeks
provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
July 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name DB Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Endpoint Up Primary Wavelength 548 Secondary Wavelength 660 Last required measrement 33 Absorbance range 0.000 – 2.500 Sample blank type Same empty cuvette Blank Assay Main Read points 31 - 33 Flex Read points 0 - 0 Raed points correction 0 - 0 Blank Read points 14 - 16
Reagent/Sample
Reagent DB Reagent Volume R1 160 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 40 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 10.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance Linearity Kinetic % Maximum Abs deviation 0.000
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.000 – 0.000
Cal Level Conc Sample Vol
BLK 0.00 10.0
Cal 1 * 10.0
Linear Range 0.0 – 10.0 Conc Units mg/dl Decimal Places 1 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position **) Factor to be checked by a calibration serum
BILIRUBIN AUTO DIRECT FS 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.
July 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name TB Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Endpoint Up Primary Wavelength 548 Secondary Wavelength 660 Last required measrement 33 Absorbance range 0.000 – 2.500 Sample blank type Same empty cuvette Blank Assay Main Read points 31 - 33 Flex Read points 0 - 0 Raed points correction 0 - 0 Blank Read points 14 - 16
Reagent/Sample
Reagent TB Reagent Volume R1 160 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 40 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 5.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance Linearity Kinetic % Maximum Abs deviation 0.000
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.000 – 0.000
Cal Level Conc Sample Vol
BLK 0.00 5.0
Cal 1 * 5.0
Linear Range 0.0 – 30.0 Conc Units mg/dl Decimal Places 1 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position **) Factor to be checked by a calibration serum
BILIRUBIN AUTO TOTAL FS 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.
July 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name CA Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Endpoint Up Primary Wavelength 628 Secondary Wavelength 700 Last required measrement 33 Absorbance range -0.500 – 2.500 Sample blank type Same empty cuvette Blank Assay Main Read points 31 - 33 Flex Read points 0 - 0 Raed points correction 0 - 0 Blank Read points 0 - 0
Reagent/Sample
Reagent CA Reagent Volume R1 200 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 0 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 2.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor 0 0 0
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance Linearity Kinetic % Maximum Abs deviation 0.000
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.00 – 0.00
Cal Level Conc Sample Vol
BLK 0.00 2.0
Cal 1 * 2.0
Cal 2
Cal 3
Cal 4
Cal 5
Linear Range 0.00 – 25.0 Conc Units mg/dl Decimal Places 1 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position
CALCIUM AS FS Order information
Cat. No. 1 1130 .. .. …
Notes
1. Please refer to the package insert for Calcium AS FS for detailed
information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is 6 weeks
provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
July 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name CKMB Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Rate Up Primary Wavelength 340 Secondary Wavelength 416 Last required measrement 33 Absorbance range 0.000 – 2.000 Sample blank type Same empty cuvette Blank Assay Main Read points 23 - 33 Flex Read points 19 - 23 Read points correction 0 - 0 Blank Read points 0 - 0
Reagent/Sample
Reagent CKMB Reagent Volume R1 200 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 50 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 10.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor 0 0 0
Validation
Reaction check type Kinetic Quotient Range read point A 19 - 22 Calculation limit 0.500 – 1.000 Range read point B 17 - 20 Minimum Absorbance 0 Linearity Kinetic % 15 Maximum Abs deviation
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.00 – 0.00
Cal Level Conc Sample Vol
BLK 0.00 10.0
Cal 1 * 10.0
Cal 2
Cal 3
Cal 4
Cal 5
Linear Range 0 – 800 Conc Units U/l Decimal Places 0 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position
CK-MB FS Order information
Cat. No. 1 1651 .. .. …
Notes
1. Please refer to the package insert for CK-MB FS for detailed
information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is 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.
July 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name CK Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Rate Up Primary Wavelength 340 Secondary Wavelength 416 Last required measrement 33 Absorbance range 0.400 – 1.800 Sample blank type Same empty cuvette Blank Assay Main Read points 24 - 33 Flex Read points 0 - 0 Read points correction 0 - 0 Blank Read points 0 - 0
Reagent/Sample
Reagent CK Reagent Volume R1 160 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 40 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 7.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor 0 0 0
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance 0 Linearity Kinetic % 15 Maximum Abs deviation
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.00 – 0.00
Cal Level Conc Sample Vol
BLK 0.00 7.0
Cal 1 * 7.0
Cal 2
Cal 3
Cal 4
Cal 5
Linear Range 0 – 1000 Conc Units U/l Decimal Places 0 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position
CK-NAC FS 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 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.
12.08.2005
APLICAÇÃO ARCHITECT
Cloro FS 1. Informações para compra Artigo Apresentação 10 120 021 R1 5 x 25 ml + 1 x 3 ml padrão 2. Programação do Analisador
GENERAL PARAMETERS
Name Cl Assay type Photometric
Assay number Assay availability Enabled
Assay version Cal version
REACTION DEFENITION
Reaction mode End Up Main read time 31 - 33
Primary wavelength 480 Flex read time 0 - 0
Secondary wavelength 700 Color correction read time 0 - 0
Last read required 33 Blank read time 0 - 0
Absorbance range 0.000 – 0.000
Sample blank type -
Blank assay
REAGENT/SAMPLE
Reagent Cl
R1 reagent volume 200 R2 reagent volume 0
R1 water volume 0 R2 water volume 0
R1 dispense mode Type 0 R2 dispense mode Type 0
Diluent name Salina Diluent dispense mode Type 0
Diluent name Sample volume Diluted S. Vol. Diluent volume Water volume Dilution factor
STANDARD 2.0 0.0 0 0 1:1
DIL1 10.0 2.0 90 0 1:10
DIL2 5.0 2.0 90 0 1:20
VALIDITY CHECKS
Reaction check type None
Read time A range Read time B range
Calculation limit Minimum absorbance
Rate linearity %
Maximum abs. variation 0.000
CALIBRATION PARAMETERS
Calibration method Linear
Use cal factor from Factor 1.0
Full interval hours 720 Adjustment interval hours
Expected cal factor 0 Adjustment level
Expected cal factor tol. % 0 Default ordering type Full
Blank absorbance rate 0.00 – 0.00
Span Span absorbance rate 0 – 0
Maximum curve fit 0
Calibrator set name TruCal U Replicates 3
Cal level Concentration Sample volume Diluted S. vol. Diluent volume Water volume
Blank 0 2.0 0 0 0
Std 1 * 2.0 0 0 0
SMART WASH
Component Reagent/Assay Wash Volume Replicates Wash protocol
Reagent probe (R1) All Water 345 1
Reagent probe (R2) All Water 345 1
RESULT PARAMETERS
Linearity range
Flag range specifications
RESULT UNITS
Result concentration units mmol/l Correlation factor 1.00
Result decimal places 1 Intercept 0.00
*Valor do Calibrador, consulte a bula do mesmo. 3. Notas 1. Para informações detalhadas do kit de Clorol FS consulte a bula conforme a seguir: Relevância Clínica Método e Principio Composição e Estabilidade dos Reagentes Amostras Calibradores e Controles
12.08.2005
Performance Características com relação a: - Faixa de Medição - Especificidade/Interferentes - Sensibilidade/Limite de Detecção - Precisão (Reprodutibilidade, Repetibilidade) - Comparação de Método Valores de Referencia Literatura 2. A estabilidade do reagente no equipamento e ao menos de 4 semanas se a contaminação e evaporação for evitada.
Produzido por: Diasys Diagnostics Systems GmbH Importado e distribuído por: Biosys LTDA
CGC: 02220795/0001-79
Resp. téc.: Vera Lúcia A. Janoni – CRF: 2848/RJ SVS: 10350840022
SAC (21) 3907-2534 - [email protected]
July 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name CHOL Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Endpoint Up Primary Wavelength 500 Secondary Wavelength 660 Last required measrement 33 Absorbance range -0.500 – 2.500 Sample blank type Same empty cuvette Blank Assay Main Read points 31 - 33 Flex Read points 0 - 0 Raed points correction 0 - 0 Blank Read points 0 - 0
Reagent/Sample
Reagent CHOL Reagent Volume R1 200 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 0 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 2.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor 0 0 0
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance Linearity Kinetic % Maximum Abs deviation 0.000
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.00 – 0.00
Cal Level Conc Sample Vol
BLK 0.00 2.0
Cal 1 * 2.0
Cal 2
Cal 3
Cal 4
Cal 5
Linear Range 3.0 – 750.0 Conc Units mg/dl Decimal Places 1 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position
CHOLESTEROL FS Order information
Cat. No. 1 1300 .. .. …
Notes
1. Please refer to the package insert for Cholesterol FS for detailed
information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is 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.
July 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name CHE Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Rate Down Primary Wavelength 404 Secondary Wavelength Last required measrement 33 Absorbance range -0.500 – 2.500 Sample blank type Same empty cuvette Blank Assay Main Read points 21 - 33 Flex Read points 0 - 0 Read points correction 0 - 0 Blank Read points 0 - 0
Reagent/Sample
Reagent CHE Reagent Volume R1 200 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 50 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 4.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor 0 0 0
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance 0 Linearity Kinetic % 15 Maximum Abs deviation
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.00 – 0.00
Cal Level Conc Sample Vol
BLK 0.00 4.0
Cal 1 * 4.0
Cal 2
Cal 3
Cal 4
Cal 5
Linear Range 0 – 20000 Conc Units U/l Decimal Places 0 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position
CHOLINESTERASE FS Order information
Cat. No. 1 1401 .. .. …
Notes
1. Please refer to the package insert for Cholinesterase FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is 6 weeks
provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
July 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name CREA Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Rate Up Primary Wavelength 500 Secondary Wavelength 572 Last required measrement 24 Absorbance range -0.500 – 2.500 Sample blank type Same empty cuvette Blank Assay Main Read points 20 - 24 Flex Read points 0 - 0 Raed points correction 0 - 0 Blank Read points 0 - 0
Reagent/Sample
Reagent CREA Reagent Volume R1 160 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 40 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 8.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor 0 0 0
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance Linearity Kinetic % Maximum Abs deviation 0.000
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.00 – 0.00
Cal Level Conc Sample Vol
BLK 0.00 8.0
Cal 1 * 8.0
Cal 2
Cal 3
Cal 4
Cal 5
Linear Range 0.2 – 15.0 Conc Units mg/dl Decimal Places 1 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position
CREATININE FS Order information
Cat. No. 1 1711 .. .. …
Notes
1. Please refer to the package insert for Creatinine FS for detailed
information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is 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.
July 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name CREAP Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Endpoint Up Primary Wavelength 546 Secondary Wavelength 700 Last required measrement 33 Absorbance range 0.000 – 2.500 Sample blank type Same empty cuvette
Blank Assay Main Read points 31 - 33 Flex Read points 0 - 0 Raed points correction 0 - 0 Blank Read points 14 - 16
Reagent/Sample
Reagent CREAP Reagent Volume R1 140 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 70 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 3 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance Linearity Kinetic % Maximum Abs deviation 0.000
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.000 – 0.000
Cal Level Conc Sample Vol
BLK 0.00 3
Cal 1 * 3
Linear Range 0.03 – 30.0 Conc Units mg/dl Decimal Places 1 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position **) Factor to be checked by a calibration serum
Creatinina PAP Este protocolo foi validado em versão de equipamento disponível na época. Notas: 1. Por favor, recorra a bula do produto para informações detalhadas sobre os seguintes testes: Relevância clínica Método e Princípio Composição e Estabilidade dos Reagentes Amostras Calibradores e Controles Desempenho e Características considerando: - Faixa de medição - Especificidade/Interferentes - Sensibilidade/Limite de Detecção - Precisão (Reprodutibilidade, Repetibilidade) - Comparação de método - Valores de referência - Literatura 2. A estabilidade do reagente a bordo do analisador é pelo menos e semanas contanto que sejam evitadas a contaminação e a evaporação. Produzido por: DiaSys Diagnostic Systems GmbH
Alte Strasse 9 IVD 65558 Holzheim Alemanha Distribuído por: Biosys Ltda. Rua Coronel Gomes Machado, 358 Niterói – Rio de Janeiro (21) 3907-2534
July 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name FERR Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Endpoint Up Primary Wavelength 572 Secondary Wavelength 804 Last required measrement 28 Absorbance range 0.000 – 2.500 Sample blank type Same empty cuvette Blank Assay Main Read points 28 - 28 Flex Read points 0 - 0 Raed points correction 0 - 0 Blank Read points 18 - 18
Reagent/Sample
Reagent FERR Reagent Volume R1 160 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 80 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 8.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance Linearity Kinetic % Maximum Abs deviation 0.000
Calibration parameters
Calibration Method Spline Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.000 – 0.000
Cal Level Conc Sample Vol
BLK 0.00 8.0
Cal 1 * 8.0
Cal 2 * 8.0
Cal 3 * 8.0
Cal 4 * 8.0
Cal 5
Linear Range 5 – 1000 Conc Units µg/l Decimal Places 0 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position **) Factor to be checked by a calibration serum
FERRITIN FS Order information
Cat. No. 1 7059 .. .. …
Notes
1. Please refer to the package insert for Ferritin FS for detailed
information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least one
month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
July 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name FE Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Endpoint Up Primary Wavelength 604 Secondary Wavelength 700 Last required measrement 33 Absorbance range 0.000 – 2.500 Sample blank type Same empty cuvette Blank Assay Main Read points 31 - 33 Flex Read points 0 - 0 Raed points correction 0 - 0 Blank Read points 14 - 16
Reagent/Sample
Reagent FE Reagent Volume R1 160 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 40 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 10.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance Linearity Kinetic % Maximum Abs deviation 0.000
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.000 – 0.000
Cal Level Conc Sample Vol
BLK 0.00 10.0
Cal 1 * 10.0
Linear Range 5 – 1000 Conc Units µg/dl Decimal Places 0 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position **) Factor to be checked by a calibration serum
IRON FS Ferene 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.
July 2009/1
PROTOCOLO ARCHITECT General Parameters
Name ALP Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Rate Up Primary Wavelength 404 Secondary Wavelength 660 Last required measrement 30 Absorbance range -0.500 – 2.500 Sample blank type Same empty cuvette Blank Assay Main Read points 20 - 30 Flex Read points 19 - 21 Read points correction 0 - 0 Blank Read points 0 - 0
Reagent/Sample
Reagent ALP Reagent Volume R1 160 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 40 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 3.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor 0 0 0
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance 0 Linearity Kinetic % 15 Maximum Abs deviation
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.00 – 0.00
Cal Level Conc Sample Vol
BLK 0.00 3.0
Cal 1 * 3.0
Cal 2
Cal 3
Cal 4
Cal 5
Linear Range # – # Conc Units U/l Decimal Places 0 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position
ALKALINE PHOSPHATASE FS IFCC 37°C
Notas: 1. Por favor, recorra a bula do produto para informações detalhadas sobre os seguintes testes: Relevância clínica Método e Princípio Composição e Estabilidade dos Reagentes Amostras Calibradores e Controles Desempenho e Características considerando: - Faixa de medição - Especificidade/Interferentes - Sensibilidade/Limite de Detecção - Precisão (Reprodutibilidade, Repetibilidade) - Comparação de método - Valores de referência - Literatura 2. A estabilidade do reagente a bordo do analisador é pelo menos um mês contanto que sejam evitadas a contaminação e a evaporação 3. Fabricado por: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
12.08.2005
APLICAÇÃO ARCHITECT
Fosfato UV FS 1. Informações para compra Artigo Apresentação 1 5211 99 10 021 R1 4 x 20 ml R2 1 x 20 ml + 1 x 3 ml padrão 1 5211 99 10 704 R1 8 x 50 ml + R2 8 x 12,5 ml 2. Programação do Analisador
GENERAL PARAMETERS
Name Fos Assay type Photometric
Assay number Assay availability Enabled
Assay version Cal version
REACTION DEFENITION
Reaction mode End Up Main read time 31 - 33
Primary wavelength 340 Flex read time 0 - 0
Secondary wavelength 380 Color correction read time 0 - 0
Last read required 33 Blank read time 14 - 16
Absorbance range 0.000 – 0.000
Sample blank type Self
Blank assay
REAGENT/SAMPLE
Reagent Fos
R1 reagent volume 160 R2 reagent volume 40
R1 water volume 0 R2 water volume 0
R1 dispense mode Type 0 R2 dispense mode Type 0
Diluent name Salina Diluent dispense mode Type 0
Diluent name Sample volume Diluted S. Vol. Diluent volume Water volume Dilution factor
STANDARD 2.0 0.0 0 0 1:1
DIL1 10.0 8.0 90 0 1:10
DIL2 10.0 4.0 90 0 1:20
VALIDITY CHECKS
Reaction check type None
Read time A range Read time B range
Calculation limit Minimum absorbance
Rate linearity %
Maximum abs. variation 0.000
CALIBRATION PARAMETERS
Calibration method Linear
Use cal factor from Factor 1.0
Full interval hours 720 Adjustment interval hours
Expected cal factor 0 Adjustment level
Expected cal factor tol. % 0 Default ordering type Full
Blank absorbance rate 0.00 – 0.00
Span Span absorbance rate 0 – 0
Maximum curve fit 0
Calibrator set name TruCal U Replicates 3
Cal level Concentration Sample volume Diluted S. vol. Diluent volume Water volume
Blank 0 2.0 0 0 0
Std 1 * 2.0 0 0 0
SMART WASH
Component Reagent/Assay Wash Volume Replicates Wash protocol
Reagent probe (R1) All Water 345 1
Reagent probe (R2) All Water 345 1
RESULT PARAMETERS
Linearity range
Flag range specifications
RESULT UNITS
Result concentration units mg/dl Correlation factor 1.00
Result decimal places 1 Intercept 0.00
*Valor do Calibrador, consulte a bula do mesmo. 3. Notas 1. Para informações detalhadas do kit de Fosfato UV FS consulte a bula conforme a seguir: Relevância Clínica Método e Principio Composição e Estabilidade dos Reagentes Amostras Calibradores e Controles
12.08.2005
Performance Características com relação a: - Faixa de Medição - Especificidade/Interferentes - Sensibilidade/Limite de Detecção - Precisão (Reprodutibilidade, Repetibilidade) - Comparação de Método Valores de Referencia Literatura 2. A estabilidade do reagente no equipamento e ao menos de 4 semanas se a contaminação e evaporação for evitada.
Produzido por: Diasys Diagnostics Systems GmbH Importado e distribuído por: Biosys LTDA
CGC: 02220795/0001-79
Resp. téc.: Vera Lúcia A. Janoni – CRF: 2848/RJ SVS: SAC (21) 3907-2534 - [email protected]
July 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name GGT Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Rate Up Primary Wavelength 404 Secondary Wavelength 660 Last required measrement 33 Absorbance range -0.500 – 2.500 Sample blank type Same empty cuvette Blank Assay Main Read points 21 - 33 Flex Read points 18 - 22 Read points correction 0 - 0 Blank Read points 0 - 0
Reagent/Sample
Reagent GGT Reagent Volume R1 160 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 40 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 4.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor 0 0 0
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance 0 Linearity Kinetic % 15 Maximum Abs deviation
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.00 – 0.00
Cal Level Conc Sample Vol
BLK 0.00 4.0
Cal 1 * 4.0
Cal 2
Cal 3
Cal 4
Cal 5
Linear Range 0 – 570 Conc Units U/l Decimal Places 0 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position
GAMMA GT FS (Szasz mod.) Order information
Cat. No. 1 2801 .. .. …
Notes
1. Please refer to the package insert for Gamma Gt FS (Szasz
mod.) for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least one
month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
July 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name GLUC Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Endpoint Up Primary Wavelength 500 Secondary Wavelength 660 Last required measrement 33 Absorbance range -0.500 – 2.500 Sample blank type Same empty cuvette Blank Assay Main Read points 31 - 33 Flex Read points 0 - 0 Raed points correction 0 - 0 Blank Read points 0 - 0
Reagent/Sample
Reagent GLUC Reagent Volume R1 200 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 0 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 2.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor 0 0 0
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance Linearity Kinetic % Maximum Abs deviation 0.000
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.00 – 0.00
Cal Level Conc Sample Vol
BLK 0.00 2.0
Cal 1 * 2.0
Cal 2
Cal 3
Cal 4
Cal 5
Linear Range 1 – 400 Conc Units mg/dl Decimal Places 1 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position
GLUCOSE GOD FS Order information
Cat. No. 1 2500 .. .. …
Notes
1. Please refer to the package insert for Glucose 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 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.
12.08.2005
APLICAÇÃO ARCHITECT
HbA1c FS 1. Informações para compra Artigo Apresentação 1 3308 99 10 730 R1 4 x 22.5 mLl + R2a 2 x 14.25 mL + R2b 2 x 0,75 mL 1 3308 99 10 735 R1 4 x 22.5 mLl + R2a 2 x 14.25 mL + R2b 2 x 0,75 mL 1 3300 99 10 058 4 x 0.5 mL TruCal HbA1c Conjunto de calibradores com 4 níveis diferentes. 2. Programação no Analisador
GENERAL PARAMETERS
Name Hb Assay type Photometric
Assay number Assay availability Enabled
Assay version Cal version
REACTION DEFENITION
Reaction mode End up Main read time 31 – 33
Primary wavelength 660 Flex read time 0
Secondary wavelength Color correction read time 0 – 0
Last read required 33 Blank read time 0 – 0
Absorbance range 0.000 – 0.000
Sample blank type -
Blank assay
REAGENT/SAMPLE
Reagent Hb
R1 reagent volume 180 R2 reagent volume 90
R1 water volume 0 R2 water volume 0
R1 dispense mode Type 0 R2 dispense mode Type 0
Diluent name Salina Diluent dispense mode Type 0
Diluent name Sample volume Diluted S. Vol. Diluent volume Water volume Dilution factor
STANDARD 5.0 0.0 0 0 1:1
DIL1 10.0 8.0 90 0 1:20
VALIDITY CHECKS
Reaction check type None
Read time A range Read time B range
Calculation limit Minimum absorbance
Rate linearity %
Maximum abs. variation 0.000
CALIBRATION PARAMETERS
Calibration method Spline
Use cal factor from Factor 1.0
Full interval hours 720 Adjustment interval hours
Expected cal factor 0 Adjustment level
Expected cal factor tol. % 0 Default ordering type Full
Blank absorbance rate 0.00 – 0.00
Span Span absorbance rate 0 – 0
Maximum curve fit 0
Calibrator set name TruCal HbA1c Replicates 3
Cal level Concentration Sample volume Diluted S. vol. Diluent volume Water volume
Blank 0 5.0 0 0 0
Std 1 * 5.0 0 0 0
Std 2 * 5.0
Std 3 * 5.0
Std 4 * 5.0
SMART WASH
Component Reagent/Assay Wash Volume Replicates Wash protocol
Reagent probe (R1) All Water 345 1
Reagent probe (R2) All Water 345 1
RESULT PARAMETERS
Linearity range
Flag range specifications
RESULT UNITS
Result concentration units % Correlation factor 1.00
Result decimal places 1 Intercept 0.00
*Valor do Calibrador, consulte a bula do mesmo. 3. Notas 1. Para informações detalhadas do kit de HbA1c consulte a bula conforme a seguir: Relevância Clínica Método e Principio Composição e Estabilidade dos Reagentes Amostras
12.08.2005
Calibradores e Controles Performance Características com relação a - Faixa de Medição - Especificidade/Interferentes - Sensibilidade/Limite de Detecção - Precisão (Reprodutibilidade, Repetibilidade) - Comparação de Método Valores de Referencia Literatura 2. A estabilidade do reagente no equipamento e ao menos de 4 semanas se a contaminação e evaporação forem evitadas. Fabricado por: DiaSys Diagnostic Systems GmbH & Co. KG
Importado e Distribuído por: Kovalent do Brasil Ltda. Rua Cristóvão Sardinha, 110 – Jd Bom Retiro – São Gonçalo - RJ.
CNPJ-04.842.199/0001-56
MS/ANVISA Nº 80115310066 SAC: +55 21 3907-2534 - [email protected] - www.kovalent.com.br
July 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name HDL Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Endpoint Up Primary Wavelength 604 Secondary Wavelength 700 Last required measrement 33 Absorbance range 0.000 – 2.500 Sample blank type Same empty cuvette Blank Assay Main Read points 31 - 33 Flex Read points 0 - 0 Raed points correction 0 - 0 Blank Read points 14 - 16
Reagent/Sample
Reagent HDL Reagent Volume R1 160 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 40 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 2.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance Linearity Kinetic % Maximum Abs deviation 0.000
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.000 – 0.000
Cal Level Conc Sample Vol
BLK 0.00 2.0
Cal 1 * 2.0
Linear Range 1 – 180 Conc Units mg/dl Decimal Places 1 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position **) Factor to be checked by a calibration serum
HDL-C IMMUNO FS 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.
October 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name LACT Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Endpoint Up Primary Wavelength 340 Secondary Wavelength 0 Last required measrement 33 Absorbance range 0.000 – 2.500 Sample blank type Same empty cuvette Blank Assay Main Read points 31 - 33 Flex Read points 0 - 0 Raed points correction 0 - 0 Blank Read points 14 - 16
Reagent/Sample
Reagent LACT Reagent Volume R1 160 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 40 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 3.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance Linearity Kinetic % Maximum Abs deviation 0.000
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.000 – 0.000
Cal Level Conc Sample Vol
BLK 0.00 3.0
Cal 1 * 3.0
Linear Range 0.0 – 120.0 Conc Units mg/dl Decimal Places 1 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position **) Factor to be checked by a calibration serum
LACTATE FS Order information
Cat. No. 1 4001 .. .. …
Notes
1. Please refer to the package insert for Lactate FS for detailed
information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least one
month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
July 2009/1
PROTOCOLO DE AUTOMAÇÃO ARCHITECT
General Parameters
Name LDH Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Rate Down Primary Wavelength 340 Secondary Wavelength 380 Last required measrement 30 Absorbance range 0.400 – 1.800 Sample blank type Same empty cuvette Blank Assay Main Read points 21 - 30 Flex Read points 18 - 22 Read points correction 0 - 0 Blank Read points 0 - 0
Reagent/Sample
Reagent LDH Reagent Volume R1 160 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 40 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 3.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor 0 0 0
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance 0 Linearity Kinetic % 15 Maximum Abs deviation
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.00 – 0.00
Cal Level Conc Sample Vol
BLK 0.00 3.0
Cal 1 * 3.0
Cal 2
Cal 3
Cal 4
Cal 5
Linear Range 0 – 1000 Conc Units U/l Decimal Places 0 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position
LDH FS DGKC Notas: 1. Por favor, recorra a bula do produto para informações detalhadas sobre os seguintes testes: Relevância clínica Método e Princípio Composição e Estabilidade dos Reagentes Amostras Calibradores e Controles Desempenho e Características considerando: - Faixa de medição - Especificidade/Interferentes - Sensibilidade/Limite de Detecção - Precisão (Reprodutibilidade, Repetibilidade) - Comparação de método
- Valores de referência - Literatura
2. A estabilidade do reagente a bordo do analisador é pelo menos
um mês contanto que sejam evitadas a contaminação e a evaporação
3. Fabricado por:
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
July 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name LDL Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Endpoint Up Primary Wavelength 604 Secondary Wavelength 700 Last required measrement 33 Absorbance range 0.000 – 2.500 Sample blank type Same empty cuvette Blank Assay Main Read points 31 - 33 Flex Read points 0 - 0 Raed points correction 0 - 0 Blank Read points 14 - 16
Reagent/Sample
Reagent LDL Reagent Volume R1 160 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 40 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 2.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance Linearity Kinetic % Maximum Abs deviation 0.000
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.000 – 0.000
Cal Level Conc Sample Vol
BLK 0.00 2.0
Cal 1 * 2.0
Linear Range 1 – 400 Conc Units mg/dl Decimal Places 1 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position **) Factor to be checked by a calibration serum
LDL-C SELECT FS Order information
Cat. No. 1 4121 .. .. …
Notes
1. Please refer to the package insert forLDL-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.
July 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name LIP Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Rate Up Primary Wavelength 572 Secondary Wavelength 700 Last required measrement 29 Absorbance range -0.500 – 2.500 Sample blank type Same empty cuvette Blank Assay Main Read points 24 - 29 Flex Read points 0 - 0 Read points correction 0 - 0 Blank Read points 0 - 0
Reagent/Sample
Reagent LIP Reagent Volume R1 160 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 40 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 4.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor 0 0 0
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance 0 Linearity Kinetic % 15 Maximum Abs deviation
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.00 – 0.00
Cal Level Conc Sample Vol
BLK 0.00 4.0
Cal 1 * 4.0
Cal 2
Cal 3
Cal 4
Cal 5
Linear Range 0 – 300 Conc Units U/l Decimal Places 0 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position
LIPASE DC FS Order information
Cat. No. 1 4321 .. .. …
Notes
1. Please refer to the package insert for Lipase DC FS for detailed
information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least 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.
July 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name Lp(a) Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Rate Up Primary Wavelength 700 Secondary Wavelength Last required measrement 25 Absorbance range 0.000 – 2.500 Sample blank type Same empty cuvette Blank Assay Main Read points 31 - 33 Flex Read points 0 - 0 Raed points correction 0 - 0 Blank Read points 19 - 21
Reagent/Sample
Reagent Lp(a) Reagent Volume R1 120 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 60 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 3.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance Linearity Kinetic % Maximum Abs deviation 0.000
Calibration parameters
Calibration Method Spline Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.000 – 0.000
Cal Level Conc Sample Vol
BLK 0.00 3.0
Cal 1 * 3.0
Cal 2 * 3.0
Cal 3 * 3.0
Cal 4 * 3.0
Cal 5 * 3.0
Linear Range 3.0 – 130.0 Conc Units mg/dl Decimal Places 1 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position **) Factor to be checked by a calibration serum
Lp(a) 21 FS Order information
Cat. No. 1 7139 .. .. …
Notes
1. Please refer to the package insert for Lp(a) 21 FS for detailed
information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least one
month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
July 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name MAG Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Endpoint Up Primary Wavelength 548 Secondary Wavelength 700 Last required measrement 33 Absorbance range -0.500 – 2.500 Sample blank type Same empty cuvette Blank Assay Main Read points 33 - 33 Flex Read points 0 - 0 Raed points correction 0 - 0 Blank Read points 0 - 0
Reagent/Sample
Reagent MAG Reagent Volume R1 200 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 0 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 2.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor 0 0 0
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance Linearity Kinetic % Maximum Abs deviation 0.000
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.00 – 0.00
Cal Level Conc Sample Vol
BLK 0.00 2.0
Cal 1 * 2.0
Cal 2
Cal 3
Cal 4
Cal 5
Linear Range 0.0 – 5.0 Conc Units mg/dl Decimal Places 1 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position
MAGNESIUM XL FS Order information
Cat. No. 1 4610 .. .. …
Notes
1. Please refer to the package insert for Magnesium XL FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is is 3 weeks
provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
January 2008/3
PROTOCOLO ARCHITECT General Parameters
Name CRP Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Endpoint Up Primary Wavelength 500 Secondary Wavelength - Last required measrement 26 Absorbance range 0.000 – 0.000 Sample blank type Same empty cuvette Blank Assay Main Read points 24 - 26 Flex Read points 0 - 0 Raed points correction 0 - 0 Blank Read points 18 - 18
Reagent/Sample
Reagent CRPus Reagent Volume R1 100 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 100 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 10.0 20.0 10.0
Vol diluted sample 0.0 4.0 4.0
Diluent volume 0 80 90
Water volume 0 0 0
Diluton factor 1:1.00 1:2.52 1:504
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance Linearity Kinetic % Maximum Abs deviation 0.000
Calibration parameters
Calibration Method Logit 4 Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.00 – 0.00
Cal Level Conc Sample Vol
BLK 0.00 10.0
Cal 1 * 10.0
Cal 2 * 10.0
Cal 3 * 10.0
Cal 4 * 10.0
Cal 5 * 10.0
Linear Range 0.00 – 35.0 Conc Units mg/dl Decimal Places 2 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position **) Factor to be checked by a calibration serum
CRP U-hs Aplicação Ultra sensível
Notas: 1. Por favor, recorra a bula do produto para informações detalhadas sobre os seguintes testes: Relevância clínica Método e Princípio Composição e Estabilidade dos Reagentes Amostras Calibradores e Controles Desempenho e Características considerando: - Faixa de medição - Especificidade/Interferentes - Sensibilidade/Limite de Detecção - Precisão (Reprodutibilidade, Repetibilidade) - Comparação de método - Valores de referência - Literatura 2. A estabilidade do reagente a bordo do analisador é pelo menos um mês contanto que sejam evitadas a contaminação e a evaporação 3. Fabricado por: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
February 2009/1
PROTOCOLO ARCHITECT General Parameters
Name CRP Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Endpoint Up Primary Wavelength 500 Secondary Wavelength 700 Last required measrement 33 Absorbance range 0.700 – 3.200 Sample blank type Same empty cuvette Blank Assay Main Read points 33 - 33 Flex Read points 0 - 0 Raed points correction 0 - 0 Blank Read points 20 - 20
Reagent/Sample
Reagent CRP Reagent Volume R1 100 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 100 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 3.0 2.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance Linearity Kinetic % Maximum Abs deviation 0.000
Calibration parameters
Calibration Method Spline Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.000 – 0.000
Cal Level Conc Sample Vol
BLK 0.00 3.0
Cal 1 * 3.0
Cal 2 * 3.0
Cal 3 * 3.0
Cal 4 * 3.0
Cal 5 * 3.0
Linear Range 0.10 – 24.0 Conc Units mg/dl Decimal Places 2 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position **) Factor to be checked by a calibration serum
CRP U-hs Aplicação Universal
Notas: 1. Por favor, recorra a bula do produto para informações detalhadas sobre os seguintes testes: Relevância clínica Método e Princípio Composição e Estabilidade dos Reagentes Amostras Calibradores e Controles Desempenho e Características considerando: - Faixa de medição - Especificidade/Interferentes - Sensibilidade/Limite de Detecção - Precisão (Reprodutibilidade, Repetibilidade) - Comparação de método - Valores de referência - Literatura 2. A estabilidade do reagente a bordo do analisador é pelo menos um mês contanto que sejam evitadas a contaminação e a evaporação 3. Fabricado por: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
July 2009/1
PROTOCOLO ARCHITECT General Parameters
Name TP Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Endpoint Up Primary Wavelength 548 Secondary Wavelength 700 Last required measrement 33 Absorbance range 0.000 – 2.500 Sample blank type Same empty cuvette Blank Assay Main Read points 31 - 33 Flex Read points 0 - 0 Raed points correction 0 - 0 Blank Read points 14 - 16
Reagent/Sample
Reagent TP Reagent Volume R1 160 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 40 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 4.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance Linearity Kinetic % Maximum Abs deviation 0.000
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.000 – 0.000
Cal Level Conc Sample Vol
BLK 0.00 4.0
Cal 1 * 4.0
Linear Range 0.05 – 15.0 Conc Units g/dl Decimal Places 1 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position **) Factor to be checked by a calibration serum
TOTAL PROTEIN FS Notas: 1. Por favor, recorra a bula do produto para informações detalhadas sobre os seguintes testes: Relevância clínica Método e Princípio Composição e Estabilidade dos Reagentes Amostras Calibradores e Controles Desempenho e Características considerando: - Faixa de medição - Especificidade/Interferentes - Sensibilidade/Limite de Detecção - Precisão (Reprodutibilidade, Repetibilidade) - Comparação de método - Valores de referência - Literatura 2. A estabilidade do reagente a bordo do analisador é pelo menos um mês contanto que sejam evitadas a contaminação e a evaporação 3. Fabricado por: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
July 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name TPU Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Endpoint Up Primary Wavelength 604 Secondary Wavelength 700 Last required measrement 33 Absorbance range -0.500 – 2.500 Sample blank type Same empty cuvette Blank Assay Main Read points 31 - 33 Flex Read points 0 - 0 Raed points correction 0 - 0 Blank Read points 0 - 0
Reagent/Sample
Reagent TPU Reagent Volume R1 200 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 0 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 4.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor 0 0 0
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance Linearity Kinetic % Maximum Abs deviation 0.000
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.00 – 0.00
Cal Level Conc Sample Vol
BLK 0.00 4.0
Cal 1 * 4.0
Cal 2
Cal 3
Cal 4
Cal 5
Linear Range 24 – 3000 Conc Units mg/L Decimal Places 0 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position
TOTAL PROTEIN UC FS Order information
Cat. No. 1 0210 .. .. …
Notes
1. Please refer to the package insert for Total Protein UC FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is 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.
July 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name AST Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Rate Down Primary Wavelength 340 Secondary Wavelength 380 Last required measrement 33 Absorbance range 0.400 – 1.800 Sample blank type Same empty cuvette Blank Assay Main Read points 21 - 33 Flex Read points 17 - 22 Read points correction 0 - 0 Blank Read points 0 - 0
Reagent/Sample
Reagent AST Reagent Volume R1 160 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 40 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 8.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor 0 0 0
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance 0 Linearity Kinetic % 15 Maximum Abs deviation
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.00 – 0.00
Cal Level Conc Sample Vol
BLK 0.00 8.0
Cal 1 * 8.0
Cal 2
Cal 3
Cal 4
Cal 5
Linear Range # – # Conc Units U/l Decimal Places 0 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position
ASAT(GOT) FS (IFCC mod.) Order information
Cat. No. 1 2601 .. .. …
Notes
1. Please refer to the package insert for ASAT(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 6 weeks
provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
July 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name ALT Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Rate Down Primary Wavelength 340 Secondary Wavelength 380 Last required measrement 33 Absorbance range 0.400 – 1.800 Sample blank type Same empty cuvette Blank Assay Main Read points 21 - 33 Flex Read points 18 - 22 Read points correction 0 - 0 Blank Read points 0 - 0
Reagent/Sample
Reagent ALT Reagent Volume R1 160 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 40 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 8.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor 0 0 0
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance 0 Linearity Kinetic % 15 Maximum Abs deviation
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.00 – 0.00
Cal Level Conc Sample Vol
BLK 0.00 8.0
Cal 1 * 8.0
Cal 2
Cal 3
Cal 4
Cal 5
Linear Range # – # Conc Units U/l Decimal Places 0 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position
ALAT(GPT) FS (IFCC mod.) Order information
Cat. No. 1 2701 .. .. …
Notes
1. Please refer to the package insert for ALAT(GPT) FS (IFCC
Mod.) for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is 6 weeks
provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
July 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name TRIG Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Endpoint Up Primary Wavelength 500 Secondary Wavelength 660 Last required measrement 33 Absorbance range -0.500 – 2.500 Sample blank type Same empty cuvette Blank Assay Main Read points 31 - 33 Flex Read points 0 - 0 Raed points correction 0 - 0 Blank Read points 0 - 0
Reagent/Sample
Reagent TRIG Reagent Volume R1 200 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 0 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 2.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor 0 0 0
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance Linearity Kinetic % Maximum Abs deviation 0.000
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.00 – 0.00
Cal Level Conc Sample Vol
BLK 0.00 2.0
Cal 1 * 2.0
Cal 2
Cal 3
Cal 4
Cal 5
Linear Range 1.0 – 1000.0 Conc Units mg/dl Decimal Places 1 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position
TRIGLYCERIDES FS Order information
Cat. No. 1 5710 .. .. …
Notes
1. Please refer to the package insert for Triglycerides FS for detailed
information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is 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.
July 2009/1
ARCHITECT SYSTEM ASSAY PARAMETERS General Parameters
Name UREA Assay Nr # Assay version 1 Assay Type Photometric Availablity Activated Cal- Version
Reaction definition
Reaction Mode Rate Down Primary Wavelength 340 Secondary Wavelength 380 Last required measrement 27 Absorbance range -0.500 – 2.500 Sample blank type Same empty cuvette Blank Assay Main Read points 22 - 27 Flex Read points 0 - 0 Read points correction 0 - 0 Blank Read points 0 - 0
Reagent/Sample
Reagent UREA Reagent Volume R1 160 Water Volume R1 0 Dispense Mode R1 Typ 0 Diluent Name NaCl Reagent Volume R2 40 Water Volume R2 0 Dispense Mode R2 Typ 0 Dispense Mode Diluent Typ 0
Dilution name Std Dil 1 Dil 2
Sample volume 2.0 0.0 0.0
Vol diluted sample 0.0 0.0 0.0
Diluent volume 0 0 0
Water volume 0 0 0
Diluton factor 0 0 0
Validation
Reaction check type No Range read point A Calculation limit Range read point B Minimum Absorbance 0 Linearity Kinetic % 15 Maximum Abs deviation
Calibration parameters
Calibration Method Linear Applied Cal Factor Interval 0 Adjustment type No Blank Abs Range 0.000 – 0.000 Abs Range 0.00 – 0.00
Cal Level Conc Sample Vol
BLK 0.00 2.0
Cal 1 * 2.0
Cal 2
Cal 3
Cal 4
Cal 5
Linear Range 2 – 300 Conc Units mg/dl Decimal Places 1 Correlation Factor 1.000 Intercept 0.000
#) Data entry by the user *) Enter calibration or standard value and position
UREA FS Order information
Cat. No. 1 3101 .. .. …
Notes
1. Please refer to the package insert for Urea FS for detailed
information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is 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.
