Albumina - Asterisco...Albumina Protocolo de Automação - PENTRA 400 Notas: 1. Por favor, recorra a...
Transcript of Albumina - Asterisco...Albumina Protocolo de Automação - PENTRA 400 Notas: 1. Por favor, recorra a...
Rev: 3 - 02/2011
Albumina
Protocolo de Automação - PENTRA 400 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: Kovalent do Brasil Ltda. Rua Cristovão Sardinha, 110 Jardim Bom Retiro – São Gonçalo
Referência Apresentação
1110060K R 1 x 60 mL + 1 x 3 mL Padrão de Albumina
1110250K R 1 x 250 mL + 1 x 3 mL Padrão de Albumina
1110300T R 12 x 25 mL + 1 x 3 mL Padrão de Albumina
1110100M R 2 x 50 mL + 1 x 3 mL Padrão de Albumina
Rev: 3 - 02/2011
General parameters Test Name Code Channel Release Modified on
Albumin ALB # Enable App. Version #
Characteristics Pre-Dilution
Result
Sample Type Serum/Plasma Diluent Name Unit g/dl
Number of Reagents Reagent 1 Factor Decimal postion 1
Reagent Incubation time (cycles) Manual Patient Validation
Reagent short name Reagent number
ALBR #
Linearity Correlation
On Board Stability 28 Low limit High limit Slope Intercept
0.2 6.000 1.0000 0.0000
# Cassette
Delta Check
Automatic Rerun Delta Check Validity Absolute Variation Relative Variation
Post Dilution
Dilution Factor 2.0 Reference Range
Man/Default Woman Child
Post Concentration Low Check 3.5
Concentration Factor High Check 5.2
Calibration parameters Test Name Code Channel Checks
Albumin ALB # Reagent Limit Absorbance Check
Pre-Dilution Reagent Range Low
Type Calibrator Diluent
Reagent Range High
Factor 1 Factor 2 Factor 3 Factor 4 Reagent Blank Limit Absorbance Check
Factor 5 Factor 6 Factor 7 Factor 8 Blank Range – Low Limit
Blank Range – High Limit
Calibration
Calibration Mode Slope Avg Validitiy Control Required
On Request
Level 1 Control Used
Time Validity
Calibration Factor *
Interval Time Unit
Runs 2 # Days
Deviation % 5.0
Calibrator Used
Analysis parameters Test Name Code Channel
Albumin ALB #
Cleaner Wavelength (nm) Blank
Cleaner Solution
H2O Primary Wavelength 600
Reagent Blank H2O
Before Secondary Wavelength 700
After
Analysis Sequence Mixing Speed
Cycle Reagent Needle Volume (µl) Sample Needle Volume (µl) H2O Vol (µl) 70
1 R1 290.0 SAMPLE 3.0 10.0
Rev: 3 - 02/2011
Calculation parameters Test Name Code Channel
Albumin ALB #
Correlation Factor Reaction Direction Sample Limit Check
Slope 1.0000 Reaction Direction Check Sample limit ( O.D.)
Intercept 0.0000 Reaction Direction Increase Sample limit cycle
Definition
Calculation Type Endpoint
Reaction limit Check First Reading Last Reading
Reaction limit Absorbance
Cycle 0 Cycle 8
Cycle
Unit parameters
Test Name Albumin
Code ALB
Channel #
Unit Conversion Factor
g/dl 1.0000
Modified On
# Input by user * Calculated by the analyser **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
Rev: 3 - 02/2011
Bilirrubina Total (Automação) Referência Apresentação
1090075K R1 3 x 20 mL + R2 1 x 15 mL
1090250K R1 5 x 40 mL + R2 1 x 50 mL
1090250T R1 10 x 20 mL + R2 2 x 25 mL
1090100M R1 2 x 40 mL + R2 2 x 10 mL
Protocolo de Automação – PENTRA 400 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: Kovalent do Brasil Ltda. Rua Cristovão Sardinha, 110 Jardim Bom Retiro – São Gonçalo
Rev: 3 - 02/2011
General parameters Test Name Code Channel Release Modified on
Total Bili BilT # Enable App. Version #
Characteristics Pre-Dilution
Result
Sample Type Serum/Plasma Diluent Name Unit mg/dl
Number of Reagents Reagent 2 Factor Decimal postion 1
Reagent Incubation time (cycles) Manual Patient Validation
Reagent short name Reagent number
TBR #
Linearity Correlation
On Board Stability 28 Low limit High limit Slope Intercept
0.1000 30.000 1.0000 0.0000
# Cassette
Delta Check
Automatic Rerun Delta Check Validity Absolute Variation Relative Variation
Post Dilution
Dilution Factor 3.0 Reference Range
Man/Default Woman Child
Post Concentration Low Check 0.100
Concentration Factor High Check 1.200
Calibration parameters Test Name Code Channel Checks
Total Bili BilT # Reagent Limit Absorbance Check
Pre-Dilution Reagent Range Low
Type Calibrator Diluent
Reagent Range High
Factor 1 Factor 2 Factor 3 Factor 4 Reagent Blank Limit Absorbance Check
Factor 5 Factor 6 Factor 7 Factor 8 Blank Range – Low Limit
Blank Range – High Limit
Calibration
Calibration Mode Slope Avg Validitiy Control Required
On Request
Level 1 Control Used
Time Validity
Calibration Factor *
Interval Time Unit
Runs 2 # Days
Deviation % 5.0
Calibrator Used
Analysis parameters Test Name Code Channel
Total Bili BilT #
Cleaner Wavelength (nm) Blank
Cleaner Solution
H2O Primary Wavelength 550
Reagent Blank H2O
Before Secondary Wavelength 660
After
Analysis Sequence Mixing Speed
Cycle Reagent Needle Volume (µl) Sample Needle Volume (µl) H2O Vol (µl) 70
1 R1 160.0 SAMPLE 8.0 10.0
6 R2 40.0 10.0
Rev: 3 - 02/2011
Calculation parameters Test Name Code Channel
Total Bili BilT #
Correlation Factor Reaction Direction Sample Limit Check
Slope 1.0000 Reaction Direction Check Sample limit ( O.D.)
Intercept 0.0000 Reaction Direction Increase Sample limit cycle
Definition
Calculation Type Endpoint
Reaction limit Check First Reading Last Reading
Reaction limit Absorbance
Cycle 5 Cycle 55
Cycle 1
Unit parameters
Test Name Total Bili
Code BilT
Channel #
Unit Conversion Factor
mg/dl 1.0000
Modified On
# Input by user * Calculated by the analyser **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
Rev: 3 - 02/2011
Bilirrubina Direta Referência Apresentação
1080075K R1 3 x 20 mL + R2 1 x 15 mL
1080250K R1 5 x 40 mL + R2 1 x 50 mL
1080250T R1 10 x 20 mL + R2 2 x 25 mL
1080100M R1 2 x 40 mL + R2 2 x 10 mL
Protocolo de Automação – PENTRA 400
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: Kovalent do Brasil Ltda. Rua Cristovão Sardinha, 110 Jardim Bom Retiro – São Gonçalo
Rev: 3 - 02/2011
General parameters Test Name Code Channel Release Modified on
Direct Bili BilD # Enable App. Version #
Characteristics Pre-Dilution
Result
Sample Type Serum/Plasma Diluent Name Unit mg/dl
Number of Reagents Reagent 2 Factor Decimal postion 1
Reagent Incubation time (cycles) Manual Patient Validation
Reagent short name Reagent number
DBR #
Linearity Correlation
On Board Stability 28 Low limit High limit Slope Intercept
0.1000 10.000 1.0000 0.0000
# Cassette
Delta Check
Automatic Rerun Delta Check Validity Absolute Variation Relative Variation
Post Dilution
Dilution Factor 3.0 Reference Range
Man/Default Woman Child
Post Concentration Low Check 0.000
Concentration Factor High Check 0.200
Calibration parameters Test Name Code Channel Checks
Direct Bili BilD # Reagent Limit Absorbance Check
Pre-Dilution Reagent Range Low
Type Calibrator Diluent
Reagent Range High
Factor 1 Factor 2 Factor 3 Factor 4 Reagent Blank Limit Absorbance Check
Factor 5 Factor 6 Factor 7 Factor 8 Blank Range – Low Limit
Blank Range – High Limit
Calibration
Calibration Mode Slope Avg Validitiy Control Required
On Request
Level 1 Control Used
Time Validity
Calibration Factor *
Interval Time Unit
Runs 2 # Days
Deviation % 5.0
Calibrator Used
Analysis parameters Test Name Code Channel
Direct Bili BilD #
Cleaner Wavelength (nm) Blank
Cleaner Solution
H2O Primary Wavelength 550
Reagent Blank H2O
Before Secondary Wavelength 660
After
Analysis Sequence Mixing Speed
Cycle Reagent Needle Volume (µl) Sample Needle Volume (µl) H2O Vol (µl) 70
1 R1 160.0 SAMPLE 16.0 10.0
6 R2 40.0 10.0
Rev: 3 - 02/2011
Calculation parameters Test Name Code Channel
Direct Bili BilD #
Correlation Factor Reaction Direction Sample Limit Check
Slope 1.0000 Reaction Direction Check Sample limit ( O.D.)
Intercept 0.0000 Reaction Direction Increase Sample limit cycle
Definition
Calculation Type Endpoint
Reaction limit Check First Reading Last Reading
Reaction limit Absorbance
Cycle 5 Cycle 55
Cycle 1
Unit parameters
Test Name Direct Bili
Code BilD
Channel #
Unit Conversion Factor
mg/dl 1.0000
Modified On
# Input by user * Calculated by the analyser **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
Rev: 3 - 02/2011
Cálcio Arsenazo III Referência Apresentação
3010060K R 1 x 60 mL + 1 x 3 mL Padrão de Cálcio
3010250K R 1 x 250 mL + 1 x 3 mL Padrão de Cálcio
3010300T R 12 x 25 mL + 1 x 3 mL Padrão de Cálcio
3010060M R 2 x 30 mL + 1 x 3 mL Padrão de Cálcio
Protocolo de Automação – PENTRA 400 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: Kovalent do Brasil Ltda. Rua Cristovão Sardinha, 110 Jardim Bom Retiro – São Gonçalo
Rev: 3 - 02/2011
General parameters Test Name Code Channel Release Modified on
Calcium CA # Enable App. Version #
Characteristics Pre-Dilution
Result
Sample Type Serum/Plasma Diluent Name Unit mg/dl
Number of Reagents Reagent 1 Factor Decimal postion 1
Reagent Incubation time (cycles) Manual Patient Validation
Reagent short name Reagent number
CAR #
Linearity Correlation
On Board Stability 28 Low limit High limit Slope Intercept
0.04 25.000 1.0000 0.0000
# Cassette
Delta Check
Automatic Rerun Delta Check Validity Absolute Variation Relative Variation
Post Dilution
Dilution Factor 2.0 Reference Range
Man/Default Woman Child
Post Concentration Low Check 8.6
Concentration Factor High Check 10.3
Calibration parameters Test Name Code Channel Checks
Calcium CA # Reagent Limit Absorbance Check
Pre-Dilution Reagent Range Low
Type Calibrator Diluent
Reagent Range High
Factor 1 Factor 2 Factor 3 Factor 4 Reagent Blank Limit Absorbance Check
Factor 5 Factor 6 Factor 7 Factor 8 Blank Range – Low Limit
Blank Range – High Limit
Calibration
Calibration Mode Slope Avg Validitiy Control Required
On Request
Level 1 Control Used
Time Validity
Calibration Factor *
Interval Time Unit
Runs 2 # Days
Deviation % 5.0
Calibrator Used
Analysis parameters Test Name Code Channel
Calcium CA #
Cleaner Wavelength (nm) Blank
Cleaner Solution
H2O Primary Wavelength 660
Reagent Blank H2O
Before Secondary Wavelength 700
After
Analysis Sequence Mixing Speed
Cycle Reagent Needle Volume (µl) Sample Needle Volume (µl) H2O Vol (µl) 70
1 R1 290.0 SAMPLE 3.0 10.0
Rev: 3 - 02/2011
Calculation parameters Test Name Code Channel
Calcium CA #
Correlation Factor Reaction Direction Sample Limit Check
Slope 1.0000 Reaction Direction Check Sample limit ( O.D.)
Intercept 0.0000 Reaction Direction Increase Sample limit cycle
Definition
Calculation Type Endpoint
Reaction limit Check First Reading Last Reading
Reaction limit Absorbance
Cycle 0 Cycle 50
Cycle
Unit parameters
Test Name Calcium
Code CA
Channel #
Unit Conversion Factor
mg/dl 1.0000
Modified On
# Input by user * Calculated by the analyser **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
Rev: 3 - 02/2011
CK-MB
Referência Apresentação
2120075K R1 3x20mL + R2 1x15mL
2120250K R1 5x40 mL + R2 1x50 mL
2120100M R1 2x40 mL + R2 2x10 mL
Protocolo de Automação – PENTRA 400 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: Kovalent do Brasil Ltda. Rua Cristovão Sardinha, 110 Jardim Bom Retiro – São Gonçalo
Rev: 3 - 02/2011
General parameters Test Name Code Channel Release Modified on
CK-MB CKMB # Enable App. Version #
Characteristics Pre-Dilution
Result
Sample Type Serum/Plasma Diluent Name Unit U/l
Number of Reagents Reagent 2 Factor Decimal postion 0
Reagent Incubation time (cycles) Manual Patient Validation
Reagent short name Reagent number
CKR #
Linearity Correlation
On Board Stability 28 Low limit High limit Slope Intercept
0.00 1500.00 1.0000 0.0000
# Cassette
Delta Check
Automatic Rerun Delta Check Validity Absolute Variation Relative Variation
Post Dilution
Dilution Factor 3.0 Reference Range
Man/Default Woman Child
Post Concentration Low Check 0
Concentration Factor High Check 24.00
Calibration parameters Test Name Code Channel Checks
CK-MB CKMB # Reagent Limit Absorbance Check
Pre-Dilution Reagent Range Low -0.0100
Type Calibrator Diluent
Reagent Range High 0.4000
Factor 1 Factor 2 Factor 3 Factor 4 Reagent Blank Limit Absorbance Check
Factor 5 Factor 6 Factor 7 Factor 8 Blank Range – Low Limit -0.0100
Blank Range – High Limit 0.0300
Calibration
Calibration Mode Slope Avg Validitiy Control Required
On Request
Level 1 Control Used
Time Validity
Calibration Factor *
Interval Time Unit
Runs 2 # Days
Deviation % 5.0
Calibrator Used
Analysis parameters Test Name Code Channel
CK-MB CKMB #
Cleaner Wavelength (nm) Blank
Cleaner Solution
H2O Primary Wavelength 340
Reagent Blank H2O
Before Secondary Wavelength 405
After
Analysis Sequence Mixing Speed
Cycle Reagent Needle Volume (µl) Sample Needle Volume (µl) H2O Vol (µl) 80
1 R1 160.0 SAMPLE 8.0 10.0
5 R2 40.0 10.0
Rev: 3 - 02/2011
Calculation parameters Test Name Code Channel
CK-MB CKMB #
Correlation Factor Reaction Direction Sample Limit Check
Slope 1.0000 Reaction Direction Check Sample limit ( O.D.) 0.0510
Intercept 0.0000 Reaction Direction Increase Sample limit cycle 6
Definition
Calculation Type Kinetic
Reaction limit Check First Reading Last Reading
Reaction limit Absorbance 0.3000
Cycle 20 Cycle 35
Cycle 6
Unit parameters
Test Name CK-MB
Code CKMB
Channel #
Unit Conversion Factor
U/l 1.0000
Modified On
# Input by user * Calculated by the analyser **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
Rev: 3 - 02/2011
CK-NAC DGKC/IFCC
Referência Apresentação
2020075K R1 3 x 20 mL + R2 1 x 15 mL
2020250K R1 5 x 40 mL + R2 1 x 50 mL
2020100M R1 2 x 40 mL + R2 2 x 10 mL
Protocolo de Automação – PENTRA 400 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: Kovalent do Brasil Ltda. Rua Cristovão Sardinha, 110 Jardim Bom Retiro – São Gonçalo
Rev: 3 - 02/2011
General parameters Test Name Code Channel Release Modified on
CK-NAC CK # Enable App. Version #
Characteristics Pre-Dilution
Result
Sample Type Serum/Plasma Diluent Name Unit U/l
Number of Reagents Reagent 2 Factor Decimal postion 0
Reagent Incubation time (cycles) Manual Patient Validation
Reagent short name Reagent number
CKR #
Linearity Correlation
On Board Stability 28 Low limit High limit Slope Intercept
0.00 1900.00 1.0000 0.0000
# Cassette
Delta Check
Automatic Rerun Delta Check Validity Absolute Variation Relative Variation
Post Dilution
Dilution Factor 3.0 Reference Range
Man/Default Woman Child
Post Concentration Low Check 0
Concentration Factor High Check 171.00
Calibration parameters Test Name Code Channel Checks
CK-NAC CK # Reagent Limit Absorbance Check
Pre-Dilution Reagent Range Low -0.0100
Type Calibrator Diluent
Reagent Range High 0.4000
Factor 1 Factor 2 Factor 3 Factor 4 Reagent Blank Limit Absorbance Check
Factor 5 Factor 6 Factor 7 Factor 8 Blank Range – Low Limit -0.0100
Blank Range – High Limit 0.0300
Calibration
Calibration Mode Slope Avg Validitiy Control Required
On Request
Level 1 Control Used
Time Validity
Calibration Factor *
Interval Time Unit
Runs 2 # Days
Deviation % 5.0
Calibrator Used
Analysis parameters Test Name Code Channel
CK-NAC CK #
Cleaner Wavelength (nm) Blank
Cleaner Solution
H2O Primary Wavelength 340
Reagent Blank H2O
Before Secondary Wavelength 405
After
Analysis Sequence Mixing Speed
Cycle Reagent Needle Volume (µl) Sample Needle Volume (µl) H2O Vol (µl) 80
1 R1 160.0 SAMPLE 8.0 10.0
5 R2 40.0 10.0
Rev: 3 - 02/2011
Calculation parameters Test Name Code Channel
CK-NAC CK #
Correlation Factor Reaction Direction Sample Limit Check
Slope 1.0000 Reaction Direction Check Sample limit ( O.D.) 0.0510
Intercept 0.0000 Reaction Direction Increase Sample limit cycle 6
Definition
Calculation Type Kinetic
Reaction limit Check First Reading Last Reading
Reaction limit Absorbance 0.3000
Cycle 20 Cycle 35
Cycle 6
Unit parameters
Test Name CK-MB
Code CKMB
Channel #
Unit Conversion Factor
U/l 1.0000
Modified On
# Input by user * Calculated by the analyser **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
Rev: 3 - 02/2011
Colesterol CHOD PAP Referência Apresentação
1020250K R 1 x 250 mL + 1 x 3 mL padrão de Colesterol
1020500K R 2 x 250 mL + 1 x 3 mL padrão de Colesterol
1020300T R 12 x 25 mL + 1 x 3 mL padrão de Colesterol
1020200M R 4 x 50 mL + 1 x 3 mL padrão de Colesterol
Protocolo de Automação – PENTRA 400 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: Kovalent do Brasil Ltda. Rua Cristovão Sardinha, 110 Jardim Bom Retiro – São Gonçalo
Rev: 3 - 02/2011
General parameters Test Name Code Channel Release Modified on
Cholesterol CHOL # Enable App. Version #
Characteristics Pre-Dilution
Result
Sample Type Serum/Plasma Diluent Name Unit mg/dl
Number of Reagents Reagent 1 Factor Decimal postion 0
Reagent Incubation time (cycles) Manual Patient Validation
Reagent short name Reagent number
CHOR #
Linearity Correlation
On Board Stability 28 Low limit High limit Slope Intercept
3.000 750.000 1.0000 0.0000
# Cassette
Delta Check
Automatic Rerun Delta Check Validity Absolute Variation Relative Variation
Post Dilution
Dilution Factor 2.0 Reference Range
Man/Default Woman Child
Post Concentration Low Check 0
Concentration Factor High Check 200
Calibration parameters Test Name Code Channel Checks
Cholesterol CHOL # Reagent Limit Absorbance Check
Pre-Dilution Reagent Range Low
Type Calibrator Diluent
Reagent Range High
Factor 1 Factor 2 Factor 3 Factor 4 Reagent Blank Limit Absorbance Check
Factor 5 Factor 6 Factor 7 Factor 8 Blank Range – Low Limit
Blank Range – High Limit
Calibration
Calibration Mode Slope Avg Validitiy Control Required
On Request
Level 1 Control Used
Time Validity
Calibration Factor *
Interval Time Unit
Runs 2 # Days
Deviation % 5.0
Calibrator Used
Analysis parameters Test Name Code Channel
Cholesterol CHOL #
Cleaner Wavelength (nm) Blank
Cleaner Solution
H2O Primary Wavelength 505
Reagent Blank H2O
Before Secondary Wavelength 700
After
Analysis Sequence Mixing Speed
Cycle Reagent Needle Volume (µl) Sample Needle Volume (µl) H2O Vol (µl) 70
1 R1 290.0 SAMPLE 3.0 10.0
Rev: 3 - 02/2011
Calculation parameters Test Name Code Channel
Cholesterol CHOL #
Correlation Factor Reaction Direction Sample Limit Check
Slope 1.0000 Reaction Direction Check Sample limit ( O.D.)
Intercept 0.0000 Reaction Direction Increase Sample limit cycle
Definition
Calculation Type Endpoint
Reaction limit Check First Reading Last Reading
Reaction limit Absorbance
Cycle 0 Cycle 50
Cycle
Unit parameters
Test Name Cholesterol
Code CHOL
Channel #
Unit Conversion Factor
mg/dl 1.0000
Modified On
# Input by user * Calculated by the analyser **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
Rev: 3 - 02/2011
Creatinina Referência Apresentação
1030250K R1 1 x 200 mL + R2 1 x 50 mL + 1 x 3 mL Padrão de Creatinina
1030500K R1 2 x 200 mL + R2 1 x 100 mL + 1 x 3 mL Padrão de Creatinina
1030250T R1 10 x 20 mL + R2 2 x 25 mL + 1 x 3 mL Padrão de Creatinina
1030200M R1 4 x 40 mL + R2 4 x 10 mL + 1 x 3 mL Padrão de Creatinina
Protocolo de Automação – PENTRA 400 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: Kovalent do Brasil Ltda. Rua Cristovão Sardinha, 110 Jardim Bom Retiro – São Gonçalo
Rev: 3 - 02/2011
Calibration parameters Test Name Code Channel Checks
Creatinine CRE # Reagent Limit Absorbance Check
Pre-Dilution Reagent Range Low
Type Calibrator Diluent
Reagent Range High
Factor 1 Factor 2 Factor 3 Factor 4 Reagent Blank Limit Absorbance Check
Factor 5 Factor 6 Factor 7 Factor 8 Blank Range – Low Limit
Blank Range – High Limit
Calibration
Calibration Mode Slope Avg Validitiy Control Required
On Request
Level 1 Control Used
Time Validity
Calibration Factor *
Interval Time Unit
Runs 2 # Days
Deviation % 5.0
Calibrator Used
Analysis parameters Test Name Code Channel
Creatinine CRE #
Cleaner Wavelength (nm) Blank
Cleaner Solution
H2O Primary Wavelength 505
Reagent Blank H2O
Before Secondary Wavelength 580
After
Analysis Sequence Mixing Speed
Cycle Reagent Needle Volume (µl) Sample Needle Volume (µl) H2O Vol (µl) 80
1 R1 160.0 SAMPLE 8.0 10.0
5 R2 40.0 10.0
General parameters Test Name Code Channel Release Modified on
Creatinine CRE # Enable App. Version #
Characteristics Pre-Dilution
Result
Sample Type Serum/Plasma Diluent Name Unit mg/dl
Number of Reagents Reagent 2 Factor Decimal postion 1
Reagent Incubation time (cycles) 1 Manual Patient Validation
Reagent short name Reagent number
CRE #
Linearity Correlation
On Board Stability 28 Low limit High limit Slope Intercept
0.2 15.000 1.0000 0.0000
# Cassette
Delta Check
Automatic Rerun Delta Check Validity Absolute Variation Relative Variation
Post Dilution
Dilution Factor 5.0 Reference Range
Man/Default Woman Child
Post Concentration Low Check 0.9
Concentration Factor High Check 1.3
Rev: 3 - 02/2011
Calculation parameters Test Name Code Channel
Creatinine CRE #
Correlation Factor Reaction Direction Sample Limit Check
Slope 1.0000 Reaction Direction Check Sample limit ( O.D.)
Intercept 0.0000 Reaction Direction Increase Sample limit cycle 1
Definition
Calculation Type Endpoint
Reaction limit Check First Reading Last Reading
Reaction limit Absorbance
Cycle 10 Cycle 19
Cycle 1
Unit parameters
Test Name Creatinine
Code CRE
Channel #
Unit Conversion Factor
mg/dl 1.0000
Modified On
# Input by user * Calculated by the analyser **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
Rev: 3 - 02/2011
Ferro Ferene Referência Apresentação
3020075K R1 3 x 20 mL + R2 1 x 15 mL + 1 x 3 mL padrão de Ferro
3020250K R1 5 x 40 mL + R2 1 x 50 mL + 1 x 3 mL padrão de Ferro
3020100M R1 2 x 40 mL + R2 2 x 10 mL + 1 x 3 mL padrão de Ferro
3020200M R1 4 x 40 mL + R2 4 x 10 mL + 1 x 3 mL padrão de Ferro
Protocolo de Automação – PENTRA 400 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: Kovalent do Brasil Ltda. Rua Cristovão Sardinha, 110 Jardim Bom Retiro – São Gonçalo
Rev: 3 - 02/2011
Calibration parameters Test Name Code Channel Checks
Iron FE # Reagent Limit Absorbance Check
Pre-Dilution Reagent Range Low
Type Calibrator Diluent
Reagent Range High
Factor 1 Factor 2 Factor 3 Factor 4 Reagent Blank Limit Absorbance Check
Factor 5 Factor 6 Factor 7 Factor 8 Blank Range – Low Limit
Blank Range – High Limit
Calibration
Calibration Mode Slope Avg Validitiy Control Required
On Request
Level 1 Control Used
Time Validity
Calibration Factor *
Interval Time Unit
Runs 2 # Days
Deviation % 5.0
Calibrator Used
Analysis parameters Test Name Code Channel
Iron FE #
Cleaner Wavelength (nm) Blank
Cleaner Solution
H2O Primary Wavelength 600
Reagent Blank H2O
Before Secondary Wavelength 700
After
Analysis Sequence Mixing Speed
Cycle Reagent Needle Volume (µl) Sample Needle Volume (µl) H2O Vol (µl) 70
1 R1 200.0 SAMPLE 2.0 10.0
15 R2 50.0 10.0
General parameters Test Name Code Channel Release Modified on
Iron FE # Enable App. Version #
Characteristics Pre-Dilution
Result
Sample Type Serum/Plasma Diluent Name Unit µg/dl
Number of Reagents Reagent 2 Factor Decimal postion 0
Reagent Incubation time (cycles) Manual Patient Validation
Reagent short name Reagent number
FER #
Linearity Correlation
On Board Stability 28 Low limit High limit Slope Intercept
5.0000 1000.000 1.0000 0.0000
# Cassette
Delta Check
Automatic Rerun Delta Check Validity Absolute Variation Relative Variation
Post Dilution
Dilution Factor 3.0 Reference Range
Man/Default Woman Child
Post Concentration Low Check 23.000
Concentration Factor High Check 168.000
Rev: 3 - 02/2011
Calculation parameters Test Name Code Channel
Iron FE #
Correlation Factor Reaction Direction Sample Limit Check
Slope 1.0000 Reaction Direction Check Sample limit ( O.D.)
Intercept 0.0000 Reaction Direction Increase Sample limit cycle
Definition
Calculation Type Endpoint
Reaction limit Check First Reading Last Reading
Reaction limit Absorbance
Cycle 14 Cycle 55
Cycle 1
Unit parameters
Test Name Iron
Code DFE
Channel #
Unit Conversion Factor
µg/dl 1.0000
Modified On
# Input by user * Calculated by the analyser **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
Rev: 3 - 02/2011
Fosfatase Alcalina (IFCC) Referência Apresentação
2030075K R1 3 x 20 ml + R2 1 x 15 ml
2030250K R1 5 x 40 ml + R2 1 X 50 ml
2030250T R1 10 x 20 ml + R2 2 x 25 ml
2030100M R1 2 x 40 ml + R2 2 x 10 ml
Protocolo de Automação – PENTRA 400 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: Kovalent do Brasil Ltda. Rua Cristovão Sardinha, 110 Jardim Bom Retiro – São Gonçalo
Rev: 3 - 02/2011
General parameters Test Name Code Channel Release Modified on
ALP ALP # Enable App. Version #
Characteristics Pre-Dilution
Result
Sample Type Serum/Plasma Diluent Name Unit U/l
Number of Reagents Reagent 2 Factor Decimal postion 0
Reagent Incubation time (cycles) Manual Patient Validation
Reagent short name Reagent number
ALPR #
Linearity Correlation
On Board Stability 28 Low limit High limit Slope Intercept
0.00 1400.00 1.0000 0.0000
# Cassette
Delta Check
Automatic Rerun Delta Check Validity Absolute Variation Relative Variation
Post Dilution
Dilution Factor 4.0 Reference Range
Man/Default Woman Child
Post Concentration Low Check 53 42
Concentration Factor High Check 128 141
Calibration parameters Test Name Code Channel Checks
ALP ALP # Reagent Limit Absorbance Check
Pre-Dilution Reagent Range Low -0.2000
Type Calibrator Diluent
Reagent Range High 2.5000
Factor 1 Factor 2 Factor 3 Factor 4 Reagent Blank Limit Absorbance Check
Factor 5 Factor 6 Factor 7 Factor 8 Blank Range – Low Limit -0.0100
Blank Range – High Limit 2.5000
Calibration
Calibration Mode Slope Avg Validitiy Control Required
On Request
Level 1 Control Used
Time Validity
Calibration Factor *
Interval Time Unit
Runs 2 # Days
Deviation % 5.0
Calibrator Used
Analysis parameters Test Name Code Channel
ALP ALP #
Cleaner Wavelength (nm) Blank
Cleaner Solution
H2O Primary Wavelength 405
Reagent Blank H2O
Before Secondary Wavelength 700
After
Analysis Sequence Mixing Speed
Cycle Reagent Needle Volume (µl) Sample Needle Volume (µl) H2O Vol (µl) 80
1 R1 160.0 SAMPLE 4.0 10.0
5 R2 40.0 10.0
Rev: 3 - 02/2011
Calculation parameters Test Name Code Channel
ALP ALP #
Correlation Factor Reaction Direction Sample Limit Check
Slope 1.0000 Reaction Direction Check Sample limit ( O.D.) 0.2500
Intercept 0.0000 Reaction Direction Increase Sample limit cycle 2
Definition
Calculation Type Kinetic
Reaction limit Check First Reading Last Reading
Reaction limit Absorbance 0.3000
Cycle 10 Cycle 25
Cycle 6
Unit parameters
Test Name ALP
Code ALP
Channel #
Unit Conversion Factor
U/l 1.0000
Modified On
# Input by user * Calculated by the analyser **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
Rev: 3 - 02/2011
Fosfato UV Referência Apresentação
3040075K R1 3 x 20 mL + R2 1 x 15 mL + 1 x 3 mL padrão de Fosfato
3040250K R1 5 x 40 mL + R2 1 x 50 mL + 1 x 3 mL padrão de Fosfato
3040250T R1 10 x 20 mL + R2 2 x 25 mL + 1 x 3 mL padrão de Fosfato
3040100M R1 2 x 40 mL + R2 2 x 10 mL + 1 x 3 mL padrão de Fosfato
Protocolo de Automação – PENTRA 400 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: Kovalent do Brasil Ltda. Rua Cristovão Sardinha, 110 Jardim Bom Retiro – São Gonçalo
Rev: 3 - 02/2011
Calibration parameters Test Name Code Channel Checks
Phosphate PO # Reagent Limit Absorbance Check
Pre-Dilution Reagent Range Low
Type Calibrator Diluent
Reagent Range High
Factor 1 Factor 2 Factor 3 Factor 4 Reagent Blank Limit Absorbance Check
Factor 5 Factor 6 Factor 7 Factor 8 Blank Range – Low Limit
Blank Range – High Limit
Calibration
Calibration Mode Slope Avg Validitiy Control Required
On Request
Level 1 Control Used
Time Validity
Calibration Factor *
Interval Time Unit
Runs 2 # Days
Deviation % 5.0
Calibrator Used
Analysis parameters Test Name Code Channel
Phosphate PO #
Cleaner Wavelength (nm) Blank
Cleaner Solution
H2O Primary Wavelength 340
Reagent Blank H2O
Before Secondary Wavelength 660
After
Analysis Sequence Mixing Speed
Cycle Reagent Needle Volume (µl) Sample Needle Volume (µl) H2O Vol (µl) 70
1 R1 160.0 SAMPLE 2.0 10.0
15 R2 40.0 10.0
General parameters Test Name Code Channel Release Modified on
Phosphate PO # Enable App. Version #
Characteristics Pre-Dilution
Result
Sample Type Serum/Plasma Diluent Name Unit mg/dl
Number of Reagents Reagent 2 Factor Decimal postion 0
Reagent Incubation time (cycles) Manual Patient Validation
Reagent short name Reagent number
POR #
Linearity Correlation
On Board Stability 28 Low limit High limit Slope Intercept
0.2000 30.000 1.0000 0.0000
# Cassette
Delta Check
Automatic Rerun Delta Check Validity Absolute Variation Relative Variation
Post Dilution
Dilution Factor 3.0 Reference Range
Man/Default Woman Child
Post Concentration Low Check 2.600
Concentration Factor High Check 4.500
Rev: 3 - 02/2011
Calculation parameters Test Name Code Channel
Phosphate PO #
Correlation Factor Reaction Direction Sample Limit Check
Slope 1.0000 Reaction Direction Check Sample limit ( O.D.)
Intercept 0.0000 Reaction Direction Increase Sample limit cycle
Definition
Calculation Type Endpoint
Reaction limit Check First Reading Last Reading
Reaction limit Absorbance
Cycle 14 Cycle 55
Cycle 1
Unit parameters
Test Name Phosphate
Code PO
Channel #
Unit Conversion Factor
mg/dl 1.0000
Modified On
# Input by user * Calculated by the analyser **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
Rev: 3 - 02/2011
Gama GT - IFCC Referência Apresentação
2070075K R1 3 x 20 mL + R2 1 x 15 mL
2070250K R1 5 x 40 mL + R2 1 x 50 mL
2070250T R1 10 x 20 mL + R2 2 x 25 mL
2070100M R1 2 x 40 mL + R2 2 x 10 mL
Protocolo de Automação – PENTRA 400 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: Kovalent do Brasil Ltda. Rua Cristovão Sardinha, 110 Jardim Bom Retiro – São Gonçalo
Rev: 3 - 02/2011
General parameters Test Name Code Channel Release Modified on
GGT GGT # Enable App. Version #
Characteristics Pre-Dilution
Result
Sample Type Serum/Plasma Diluent Name Unit U/l
Number of Reagents Reagent 2 Factor Decimal postion 0
Reagent Incubation time (cycles) Manual Patient Validation
Reagent short name Reagent number
GGTR #
Linearity Correlation
On Board Stability 28 Low limit High limit Slope Intercept
0.00 285.00 1.0000 0.0000
# Cassette
Delta Check
Automatic Rerun Delta Check Validity Absolute Variation Relative Variation
Post Dilution
Dilution Factor 3.0 Reference Range
Man/Default Woman Child
Post Concentration Low Check 0
Concentration Factor High Check 55.00
Calibration parameters Test Name Code Channel Checks
GGT GGT # Reagent Limit Absorbance Check
Pre-Dilution Reagent Range Low -0.2000
Type Calibrator Diluent
Reagent Range High 2.0000
Factor 1 Factor 2 Factor 3 Factor 4 Reagent Blank Limit Absorbance Check
Factor 5 Factor 6 Factor 7 Factor 8 Blank Range – Low Limit -0.0400
Blank Range – High Limit 2.0000
Calibration
Calibration Mode Slope Avg Validitiy Control Required
On Request
Level 1 Control Used
Time Validity
Calibration Factor *
Interval Time Unit
Runs 2 # Days
Deviation % 5.0
Calibrator Used
Analysis parameters Test Name Code Channel
GGT GGT #
Cleaner Wavelength (nm) Blank
Cleaner Solution
H2O Primary Wavelength 405
Reagent Blank H2O
Before Secondary Wavelength 660
After
Analysis Sequence Mixing Speed
Cycle Reagent Needle Volume (µl) Sample Needle Volume (µl) H2O Vol (µl) 80
1 R1 160.0 SAMPLE 16.0 10.0
15 R2 40.0 10.0
Rev: 3 - 02/2011
Calculation parameters Test Name Code Channel
GGT GGT #
Correlation Factor Reaction Direction Sample Limit Check
Slope 1.0000 Reaction Direction Check Sample limit ( O.D.) 0.200
Intercept 0.0000 Reaction Direction Increase Sample limit cycle 2
Definition
Calculation Type Kinetic
Reaction limit Check First Reading Last Reading
Reaction limit Absorbance 0.200
Cycle 20 Cycle 35
Cycle 16
Unit parameters
Test Name GGT
Code GGT
Channel #
Unit Conversion Factor
U/l 1.0000
Modified On
# Input by user * Calculated by the analyser **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
Rev: 1 - 07/2011
Glicose Hexokinase
Referência Apresentação
1130250T R1 10 x 20 mL + R2 2 x 25 mL
1130500K R1 2 x 200 mL + R2 1 x 100 mL
Protocolo de Automação – PENTRA 400
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: Kovalent do Brasil Ltda. Rua Cristovão Sardinha, 110 Jardim Bom Retiro – São Gonçalo
Rev: 1 - 07/2011
General parameters Test Name Code Channel Release Modified on
Glucose Gluc # Enable App. Version #
Characteristics Pre-Dilution
Result
Sample Type Serum/Plasma Diluent Name Unit mg/dl
Number of Reagents Reagent 2 Factor Decimal postion 0
Reagent Incubation time (cycles) Manual Patient Validation
Reagent short name Reagent number
GLR #
Linearity Correlation
On Board Stability 28 Low limit High limit Slope Intercept
2.0000 900.000 1.0000 0.0000
# Cassette
Delta Check
Automatic Rerun Delta Check Validity Absolute Variation Relative Variation
Post Dilution
Dilution Factor 3.0 Reference Range
Man/Default Woman Child
Post Concentration Low Check 70.000
Concentration Factor High Check 115.000
Calibration parameters Test Name Code Channel Checks
Glucose Gluc # Reagent Limit Absorbance Check
Pre-Dilution Reagent Range Low
Type Calibrator Diluent
Reagent Range High
Factor 1 Factor 2 Factor 3 Factor 4 Reagent Blank Limit Absorbance Check
Factor 5 Factor 6 Factor 7 Factor 8 Blank Range – Low Limit
Blank Range – High Limit
Calibration
Calibration Mode Slope Avg Validitiy Control Required
On Request
Level 1 Control Used
Time Validity
Calibration Factor *
Interval Time Unit
Runs 2 # Days
Deviation % 5.0
Calibrator Used
Analysis parameters Test Name Code Channel
Glucose Gluc #
Cleaner Wavelength (nm) Blank
Cleaner Solution
H2O Primary Wavelength 340
Reagent Blank H2O
Before Secondary Wavelength 405
After
Analysis Sequence Mixing Speed
Cycle Reagent Needle Volume (µl) Sample Needle Volume (µl) H2O Vol (µl) 70
1 R1 160.0 SAMPLE 2.0 10.0
6 R2 40.0 10.0
Rev: 1 - 07/2011
Calculation parameters Test Name Code Channel
Glucose Gluc #
Correlation Factor Reaction Direction Sample Limit Check
Slope 1.0000 Reaction Direction Check Sample limit ( O.D.)
Intercept 0.0000 Reaction Direction Increase Sample limit cycle
Definition
Calculation Type Endpoint
Reaction limit Check First Reading Last Reading
Reaction limit Absorbance
Cycle 5 Cycle 55
Cycle 1
Unit parameters
Test Name Glucose
Code Gluc
Channel #
Unit Conversion Factor
mg/dl 1.0000
Modified On
# Input by user * Calculated by the analyser **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
Rev: 3 - 02/2011
Glicose GOD-PAP
Referência Apresentação
1040250K R 1 x 250 mL + 1 x 3 mL padrão de Glicose
1040500K R 2 x 250 mL + 1 x 3 mL padrão de Glicose
1040300T R 12 x 25 mL + 1 x 3 mL padrão de Glicose
1040200M R 4 x 50 mL + 1 x 3 mL padrão de Glicose
Protocolo de Automação – PENTRA 400
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: Kovalent do Brasil Ltda. Rua Cristovão Sardinha, 110 Jardim Bom Retiro – São Gonçalo
Rev: 3 - 02/2011
General parameters Test Name Code Channel Release Modified on
Glucose GLU # Enable App. Version #
Characteristics Pre-Dilution
Result
Sample Type Serum/Plasma Diluent Name Unit mg/dl
Number of Reagents Reagent 1 Factor Decimal postion 0
Reagent Incubation time (cycles) Manual Patient Validation
Reagent short name Reagent number
GLUR #
Linearity Correlation
On Board Stability 28 Low limit High limit Slope Intercept
1.000 400.000 1.0000 0.0000
# Cassette
Delta Check
Automatic Rerun Delta Check Validity Absolute Variation Relative Variation
Post Dilution
Dilution Factor 2.0 Reference Range
Man/Default Woman Child
Post Concentration Low Check 70
Concentration Factor High Check 115
Calibration parameters Test Name Code Channel Checks
Glucose GLU # Reagent Limit Absorbance Check
Pre-Dilution Reagent Range Low
Type Calibrator Diluent
Reagent Range High
Factor 1 Factor 2 Factor 3 Factor 4 Reagent Blank Limit Absorbance Check
Factor 5 Factor 6 Factor 7 Factor 8 Blank Range – Low Limit
Blank Range – High Limit
Calibration
Calibration Mode Slope Avg Validitiy Control Required
On Request
Level 1 Control Used
Time Validity
Calibration Factor *
Interval Time Unit
Runs 2 # Days
Deviation % 5.0
Calibrator Used
Analysis parameters Test Name Code Channel
Glucose GLU #
Cleaner Wavelength (nm) Blank
Cleaner Solution
H2O Primary Wavelength 505
Reagent Blank H2O
Before Secondary Wavelength 700
After
Analysis Sequence Mixing Speed
Cycle Reagent Needle Volume (µl) Sample Needle Volume (µl) H2O Vol (µl) 70
1 R1 290.0 SAMPLE 3.0 10.0
Rev: 3 - 02/2011
Calculation parameters Test Name Code Channel
Glucose GLU #
Correlation Factor Reaction Direction Sample Limit Check
Slope 1.0000 Reaction Direction Check Sample limit ( O.D.)
Intercept 0.0000 Reaction Direction Increase Sample limit cycle
Definition
Calculation Type Endpoint
Reaction limit Check First Reading Last Reading
Reaction limit Absorbance
Cycle 0 Cycle 24
Cycle
Unit parameters
Test Name Glucose
Code GLU
Channel #
Unit Conversion Factor
g/dl 1.0000
Modified On
# Input by user * Calculated by the analyser **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
Rev: 3 - 02/2011
HDL-C Imuno Referência Apresentação
1050075K R1 3 x 20 mL + R2 1 x 15 mL
1050250K R1 1 x 200 mL + R2 1 x 50 mL
1050075T R1 2 x 30 mL + R2 1 x 15 mL
1050250T R1 10 x 20 mL + R2 2 x 25 mL
1050200M R1 4 x 40 mL + R2 4 x 10 mL
Protocolo de Automação – PENTRA 400 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: Kovalent do Brasil Ltda. Rua Cristovão Sardinha, 110 Jardim Bom Retiro – São Gonçalo
Rev: 3 - 02/2011
General parameters Test Name Code Channel Release Modified on
HDL HDL # Enable App. Version #
Characteristics Pre-Dilution
Result
Sample Type Serum/Plasma Diluent Name Unit mg/dl
Number of Reagents Reagent 2 Factor Decimal postion 1
Reagent Incubation time (cycles) Manual Patient Validation
Reagent short name Reagent number
HDLR #
Linearity Correlation
On Board Stability 28 Low limit High limit Slope Intercept
1.0000 180.000 1.0000 0.0000
# Cassette
Delta Check
Automatic Rerun Delta Check Validity Absolute Variation Relative Variation
Post Dilution
Dilution Factor 3.0 Reference Range
Man/Default Woman Child
Post Concentration Low Check 35.000
Concentration Factor High Check 80.000
Calibration parameters Test Name Code Channel Checks
HDL HDL # Reagent Limit Absorbance Check
Pre-Dilution Reagent Range Low
Type Calibrator Diluent
Reagent Range High
Factor 1 Factor 2 Factor 3 Factor 4 Reagent Blank Limit Absorbance Check
Factor 5 Factor 6 Factor 7 Factor 8 Blank Range – Low Limit
Blank Range – High Limit
Calibration
Calibration Mode Slope Avg Validitiy Control Required
On Request
Level 1 Control Used
Time Validity
Calibration Factor *
Interval Time Unit
Runs 2 # Days
Deviation % 5.0
Calibrator Used
Analysis parameters Test Name Code Channel
HDL HDL #
Cleaner Wavelength (nm) Blank
Cleaner Solution
H2O Primary Wavelength 600
Reagent Blank H2O
Before Secondary Wavelength 700
After
Analysis Sequence Mixing Speed
Cycle Reagent Needle Volume (µl) Sample Needle Volume (µl) H2O Vol (µl) 70
1 R1 200.0 SAMPLE 2.0 10.0
15 R2 50.0 10.0
Rev: 3 - 02/2011
Calculation parameters Test Name Code Channel
HDL HDL #
Correlation Factor Reaction Direction Sample Limit Check
Slope 1.0000 Reaction Direction Check Sample limit ( O.D.)
Intercept 0.0000 Reaction Direction Increase Sample limit cycle
Definition
Calculation Type Endpoint
Reaction limit Check First Reading Last Reading
Reaction limit Absorbance
Cycle 14 Cycle 55
Cycle 1
Unit parameters
Test Name HDL
Code HDL
Channel #
Unit Conversion Factor
mg/dl 1.0000
Modified On
# Input by user * Calculated by the analyser **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
04/2012
Lactato
Referência Apresentação
1100075K R1 3x20mL + R2 1x15mL
1100250K R1 5x40mL + R2 1x50mL
Protocolo de Automação – PENTRA 400
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: Kovalent do Brasil Ltda. Rua Cristovão Sardinha, 110 Jardim Bom Retiro – São Gonçalo
04/2012
General parameters Test Name Code Channel Release Modified on
Lactato Lac # Enable App. Version #
Characteristics Pre-Dilution
Result
Sample Type Serum/Plasma Diluent Name Unit mg/dl
Number of Reagents Reagent 2 Factor Decimal postion 0
Reagent Incubation time (cycles) Manual Patient Validation
Reagent short name Reagent number
Lact #
Linearity Correlation
On Board Stability 28 Low limit High limit Slope Intercept
1.000 120.000 1.0000 0.0000
# Cassette
Delta Check
Automatic Rerun Delta Check Validity Absolute Variation Relative Variation
Post Dilution
Dilution Factor 2.0 Reference Range
Man/Default Woman Child
Post Concentration Low Check
Concentration Factor High Check
Calibration parameters Test Name Code Channel Checks
Lactato Lac # Reagent Limit Absorbance Check
Pre-Dilution Reagent Range Low
Type Calibrator Diluent
Reagent Range High
Factor 1 Factor 2 Factor 3 Factor 4 Reagent Blank Limit Absorbance Check
Factor 5 Factor 6 Factor 7 Factor 8 Blank Range – Low Limit
Blank Range – High Limit
Calibration
Calibration Mode Slope Avg Validitiy Control Required
On Request
Level 1 Control Used
Time Validity
Calibration Factor *
Interval Time Unit
Runs 1 # Days
Deviation % 5.0
Calibrator Used
Analysis parameters Test Name Code Channel
Lactato Lac #
Cleaner Wavelength (nm) Blank
Cleaner Solution
H2O Primary Wavelength 340
Reagent Blank H2O
Before Secondary Wavelength -
After
Analysis Sequence Mixing Speed
Cycle Reagent Needle Volume (µl) Sample Needle Volume (µl) H2O Vol (µl) 70
1 R1 180.0 SAMPLE 3.0 10.0
15 R2 45 10.0
04/2012
Calculation parameters Test Name Code Channel
Lactato Lac #
Correlation Factor Reaction Direction Sample Limit Check
Slope 1.0000 Reaction Direction Check Sample limit ( O.D.)
Intercept 0.0000 Reaction Direction Increase Sample limit cycle
Definition
Calculation Type Endpoint
Reaction limit Check First Reading Last Reading
Reaction limit Absorbance
Cycle 0 Cycle 24
Cycle
Unit parameters
Test Name Lactato
Code Lac
Channel #
Unit Conversion Factor
mg/dl 1.0000
Modified On
# Input by user * Calculated by the analyser **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
Rev: 3 - 02/2011
LDH - DGKC Referência Apresentação
2100075K R1 3 x 20 mL + R2 1 x 15 mL
2100250T R1 10 x 20 mL + R2 2 x 25 mL
2100100M R1 2 x 40 mL + R2 2 x 10 mL
Protocolo de Automação – PENTRA 400 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: Kovalent do Brasil Ltda. Rua Cristovão Sardinha, 110 Jardim Bom Retiro – São Gonçalo
Rev: 3 - 02/2011
General parameters Test Name Code Channel Release Modified on
LDH LDH # Enable App. Version #
Characteristics Pre-Dilution
Result
Sample Type Serum/Plasma Diluent Name Unit U/l
Number of Reagents Reagent 2 Factor Decimal postion 0
Reagent Incubation time (cycles) Manual Patient Validation
Reagent short name Reagent number
LDHR #
Linearity Correlation
On Board Stability 28 Low limit High limit Slope Intercept
0.00 1700.00 1.0000 0.0000
# Cassette
Delta Check
Automatic Rerun Delta Check Validity Absolute Variation Relative Variation
Post Dilution
Dilution Factor 3.0 Reference Range
Man/Default Woman Child
Post Concentration Low Check 0
Concentration Factor High Check 480.00
Calibration parameters Test Name Code Channel Checks
LDH LDH # Reagent Limit Absorbance Check
Pre-Dilution Reagent Range Low -0.2000
Type Calibrator Diluent
Reagent Range High 2.0000
Factor 1 Factor 2 Factor 3 Factor 4 Reagent Blank Limit Absorbance Check
Factor 5 Factor 6 Factor 7 Factor 8 Blank Range – Low Limit -0.0400
Blank Range – High Limit 0.1000
Calibration
Calibration Mode Slope Avg Validitiy Control Required
On Request
Level 1 Control Used
Time Validity
Calibration Factor *
Interval Time Unit
Runs 2 # Days
Deviation % 5.0
Calibrator Used
Analysis parameters Test Name Code Channel
LDH LDH #
Cleaner Wavelength (nm) Blank
Cleaner Solution
H2O Primary Wavelength 340
Reagent Blank H2O
Before Secondary Wavelength 420
After
Analysis Sequence Mixing Speed
Cycle Reagent Needle Volume (µl) Sample Needle Volume (µl) H2O Vol (µl) 80
1 R1 160.0 SAMPLE 3.0 10.0
15 R2 40.0 10.0
Rev: 3 - 02/2011
Calculation parameters Test Name Code Channel
LDH LDH #
Correlation Factor Reaction Direction Sample Limit Check
Slope 1.0000 Reaction Direction Check Sample limit ( O.D.) 0.1200
Intercept 0.0000 Reaction Direction Decrease Sample limit cycle 2
Definition
Calculation Type Kinetic
Reaction limit Check First Reading Last Reading
Reaction limit Absorbance 0.0800
Cycle 19 Cycle 28
Cycle 16
Unit parameters
Test Name LDH
Code LDH
Channel #
Unit Conversion Factor
U/l 1.0000
Modified On
# Input by user * Calculated by the analyser **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
Rev: 3 - 02/2011
Magnésio
Referência Apresentação
3030060K R 1 x 60 mL + 1 x 3 mL Padrão de Magnésio
3030250K R 1 x 250 mL + 1 x 3 mL Padrão de Magnésio
3030300T R 12 x 25mL + 1 x 3 mL Padrão de Magnésio
3030060M R 2 x 30 mL + 1 x 3 mL Padrão de Magnésio
3030100M R 2 x 50 mL + 1 x 3 mL Padrão de Magnésio
Protocolo de Automação – PENTRA 400 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: Kovalent do Brasil Ltda. Rua Cristovão Sardinha, 110 Jardim Bom Retiro – São Gonçalo
Rev: 3 - 02/2011
General parameters Test Name Code Channel Release Modified on
Magnesium MG # Enable App. Version #
Characteristics Pre-Dilution
Result
Sample Type Serum/Plasma Diluent Name Unit mg/dl
Number of Reagents Reagent 1 Factor Decimal postion 1
Reagent Incubation time (cycles) Manual Patient Validation
Reagent short name Reagent number
MGR #
Linearity Correlation
On Board Stability 28 Low limit High limit Slope Intercept
0.05 5.000 1.0000 0.0000
# Cassette
Delta Check
Automatic Rerun Delta Check Validity Absolute Variation Relative Variation
Post Dilution
Dilution Factor 2.0 Reference Range
Man/Default Woman Child
Post Concentration Low Check 1.8
Concentration Factor High Check 2.6
Calibration parameters Test Name Code Channel Checks
Magnesium MG # Reagent Limit Absorbance Check
Pre-Dilution Reagent Range Low
Type Calibrator Diluent
Reagent Range High
Factor 1 Factor 2 Factor 3 Factor 4 Reagent Blank Limit Absorbance Check
Factor 5 Factor 6 Factor 7 Factor 8 Blank Range – Low Limit
Blank Range – High Limit
Calibration
Calibration Mode Slope Avg Validitiy Control Required
On Request
Level 1 Control Used
Time Validity
Calibration Factor *
Interval Time Unit
Runs 2 # Days
Deviation % 5.0
Calibrator Used
Analysis parameters Test Name Code Channel
Magnesium MG #
Cleaner Wavelength (nm) Blank
Cleaner Solution
H2O Primary Wavelength 550
Reagent Blank H2O
Before Secondary Wavelength 700
After
Analysis Sequence Mixing Speed
Cycle Reagent Needle Volume (µl) Sample Needle Volume (µl) H2O Vol (µl) 70
1 R1 290.0 SAMPLE 3.0 10.0
Rev: 3 - 02/2011
Calculation parameters Test Name Code Channel
Magnesium MG #
Correlation Factor Reaction Direction Sample Limit Check
Slope 1.0000 Reaction Direction Check Sample limit ( O.D.)
Intercept 0.0000 Reaction Direction Increase Sample limit cycle
Definition
Calculation Type Endpoint
Reaction limit Check First Reading Last Reading
Reaction limit Absorbance
Cycle 0 Cycle 50
Cycle
Unit parameters
Test Name Magnesium
Code MG
Channel #
Unit Conversion Factor
mg/dl 1.0000
Modified On
# Input by user * Calculated by the analyser **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
Rev: 3 - 02/2011
Proteína Total Referência Apresentação
1120075K R1 3 x 20 mL + R2 1 x 15 mL + 1 x 3 mL Padrão de Proteína Total
1120250K R1 5 x 40 mL + R2 1 x 50 mL + 1 x 3 mL Padrão de Proteína Total
1120250T R1 10 x 20 mL + R2 2 x 25 mL + 1 x 3 mL Padrão de Proteína Total
1120100M R1 2 x 40 mL + R2 2 x 10 mL + 1 x 3 mL Padrão de Proteína Total
Protocolo de Automação – PENTRA 400 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: Kovalent do Brasil Ltda. Rua Cristovão Sardinha, 110 Jardim Bom Retiro – São Gonçalo
Rev: 3 - 02/2011
General parameters Test Name Code Channel Release Modified on
Total Protein TP # Enable App. Version #
Characteristics Pre-Dilution
Result
Sample Type Serum/Plasma Diluent Name Unit g/l
Number of Reagents Reagent 2 Factor Decimal postion 1
Reagent Incubation time (cycles) Manual Patient Validation
Reagent short name Reagent number
TPR #
Linearity Correlation
On Board Stability 28 Low limit High limit Slope Intercept
1.5000 150.000 1.0000 0.0000
# Cassette
Delta Check
Automatic Rerun Delta Check Validity Absolute Variation Relative Variation
Post Dilution
Dilution Factor 3.0 Reference Range
Man/Default Woman Child
Post Concentration Low Check 66.000
Concentration Factor High Check 88.000
Calibration parameters Test Name Code Channel Checks
Total Protein TP # Reagent Limit Absorbance Check
Pre-Dilution Reagent Range Low
Type Calibrator Diluent
Reagent Range High
Factor 1 Factor 2 Factor 3 Factor 4 Reagent Blank Limit Absorbance Check
Factor 5 Factor 6 Factor 7 Factor 8 Blank Range – Low Limit
Blank Range – High Limit
Calibration
Calibration Mode Slope Avg Validitiy Control Required
On Request
Level 1 Control Used
Time Validity
Calibration Factor *
Interval Time Unit
Runs 2 # Days
Deviation % 5.0
Calibrator Used
Analysis parameters Test Name Code Channel
Total Protein TP #
Cleaner Wavelength (nm) Blank
Cleaner Solution
H2O Primary Wavelength 550
Reagent Blank H2O
Before Secondary Wavelength 700
After
Analysis Sequence Mixing Speed
Cycle Reagent Needle Volume (µl) Sample Needle Volume (µl) H2O Vol (µl) 70
1 R1 160.0 SAMPLE 4.0 10.0
6 R2 40.0 10.0
Rev: 3 - 02/2011
Calculation parameters Test Name Code Channel
Total Protein TP #
Correlation Factor Reaction Direction Sample Limit Check
Slope 1.0000 Reaction Direction Check Sample limit ( O.D.)
Intercept 0.0000 Reaction Direction Increase Sample limit cycle
Definition
Calculation Type Endpoint
Reaction limit Check First Reading Last Reading
Reaction limit Absorbance
Cycle 5 Cycle 55
Cycle 1
Unit parameters
Test Name Total Protein
Code TP
Channel #
Unit Conversion Factor
g/l 1.0000
Modified On
# Input by user * Calculated by the analyser **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
Rev: 3 - 02/2011
TGO (IFCC) Referência Apresentação
2040075K R1 3 x 20 mL + R2 1 x 15 mL
2040250K R1 5 x 40 mL + R2 1 x 50 mL
2040250T R1 10 x 20 mL + R2 2 x 25 mL
2040100M R1 2 x 40 mL + R2 2 x 10 mL
Protocolo de Automação – PENTRA 400 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: Kovalent do Brasil Ltda. Rua Cristovão Sardinha, 110 Jardim Bom Retiro – São Gonçalo
Rev: 3 - 02/2011
General parameters Test Name Code Channel Release Modified on
AST AST # Enable App. Version #
Characteristics Pre-Dilution
Result
Sample Type Serum/Plasma Diluent Name Unit U/l
Number of Reagents Reagent 2 Factor Decimal postion 0
Reagent Incubation time (cycles) Manual Patient Validation
Reagent short name Reagent number
ASTR #
Linearity Correlation
On Board Stability 28 Low limit High limit Slope Intercept
4.00 450.00 1.0000 0.0000
# Cassette
Delta Check
Automatic Rerun Delta Check Validity Absolute Variation Relative Variation
Post Dilution
Dilution Factor 3.0 Reference Range
Man/Default Woman Child
Post Concentration Low Check 0
Concentration Factor High Check 37.00
Calibration parameters Test Name Code Channel Checks
AST AST # Reagent Limit Absorbance Check
Pre-Dilution Reagent Range Low -0.2000
Type Calibrator Diluent
Reagent Range High 1.6000
Factor 1 Factor 2 Factor 3 Factor 4 Reagent Blank Limit Absorbance Check
Factor 5 Factor 6 Factor 7 Factor 8 Blank Range – Low Limit -0.0400
Blank Range – High Limit 0.0100
Calibration
Calibration Mode Slope Avg Validitiy Control Required
On Request
Level 1 Control Used
Time Validity
Calibration Factor *
Interval Time Unit
Runs 2 # Days
Deviation % 5.0
Calibrator Used
Analysis parameters Test Name Code Channel
AST AST #
Cleaner Wavelength (nm) Blank
Cleaner Solution
H2O Primary Wavelength 340
Reagent Blank H2O
Before Secondary Wavelength 420
After
Analysis Sequence Mixing Speed
Cycle Reagent Needle Volume (µl) Sample Needle Volume (µl) H2O Vol (µl) 80
1 R1 160.0 SAMPLE 20.0 10.0
15 R2 40.0 10.0
Rev: 3 - 02/2011
Calculation parameters Test Name Code Channel
AST AST #
Correlation Factor Reaction Direction Sample Limit Check
Slope 1.0000 Reaction Direction Check Sample limit ( O.D.) 0.1200
Intercept 0.0000 Reaction Direction Decrease Sample limit cycle 2
Definition
Calculation Type Kinetic
Reaction limit Check First Reading Last Reading
Reaction limit Absorbance 0.0800
Cycle 18 Cycle 30
Cycle 16
Unit parameters
Test Name AST
Code AST
Channel #
Unit Conversion Factor
U/l 1.0000
Modified On
# Input by user * Calculated by the analyser **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
Rev: 3 - 02/2011
TGP (IFCC) Referência Apresentação
2050075K R1 3 x 20 mL + R2 1 x 15 mL
2050250K R1 5 x 40 mL + R2 1 x 50 mL
2050250T R1 10 x 20 mL + R2 2 x 25 mL
2050100T R1 2 x 40 mL + R2 2 x 10 mL
Protocolo de Automação – PENTRA 400 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: Kovalent do Brasil Ltda. Rua Cristovão Sardinha, 110 Jardim Bom Retiro – São Gonçalo
Rev: 3 - 02/2011
General parameters Test Name Code Channel Release Modified on
ALT ALT # Enable App. Version #
Characteristics Pre-Dilution
Result
Sample Type Serum/Plasma Diluent Name Unit U/l
Number of Reagents Reagent 2 Factor Decimal postion 0
Reagent Incubation time (cycles) Manual Patient Validation
Reagent short name Reagent number
ALTR #
Linearity Correlation
On Board Stability 28 Low limit High limit Slope Intercept
4.00 600.00 1.0000 0.0000
# Cassette
Delta Check
Automatic Rerun Delta Check Validity Absolute Variation Relative Variation
Post Dilution
Dilution Factor 3.0 Reference Range
Man/Default Woman Child
Post Concentration Low Check 0
Concentration Factor High Check 41.00
Calibration parameters Test Name Code Channel Checks
ALT ALT # Reagent Limit Absorbance Check
Pre-Dilution Reagent Range Low -0.2000
Type Calibrator Diluent
Reagent Range High 1.6000
Factor 1 Factor 2 Factor 3 Factor 4 Reagent Blank Limit Absorbance Check
Factor 5 Factor 6 Factor 7 Factor 8 Blank Range – Low Limit -0.0400
Blank Range – High Limit 0.0100
Calibration
Calibration Mode Slope Avg Validitiy Control Required
On Request
Level 1 Control Used
Time Validity
Calibration Factor *
Interval Time Unit
Runs 2 # Days
Deviation % 5.0
Calibrator Used
Analysis parameters Test Name Code Channel
ALT ALT #
Cleaner Wavelength (nm) Blank
Cleaner Solution
H2O Primary Wavelength 340
Reagent Blank H2O
Before Secondary Wavelength 420
After
Analysis Sequence Mixing Speed
Cycle Reagent Needle Volume (µl) Sample Needle Volume (µl) H2O Vol (µl) 80
1 R1 160.0 SAMPLE 20.0 10.0
15 R2 40.0 10.0
Rev: 3 - 02/2011
Calculation parameters Test Name Code Channel
ALT ALT #
Correlation Factor Reaction Direction Sample Limit Check
Slope 1.0000 Reaction Direction Check Sample limit ( O.D.) 0.1200
Intercept 0.0000 Reaction Direction Decrease Sample limit cycle 2
Definition
Calculation Type Kinetic
Reaction limit Check First Reading Last Reading
Reaction limit Absorbance 0.0800
Cycle 18 Cycle 30
Cycle 16
Unit parameters
Test Name ALT
Code ALT
Channel #
Unit Conversion Factor
U/l 1.0000
Modified On
# Input by user * Calculated by the analyser **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
Rev: 3 - 02/2011
Triglicerídeos GPO-PAP
Referência Apresentação
1060250K R 1 x 250 mL + 1 x 3 mL padrão de Triglicerídeos
1060500K R 2 x 250 mL + 1 x 3 mL padrão de Triglicerídeos
1060300T R 12 x 25 mL + 1 x 3 mL padrão de Triglicerídeos
1060200M R 4 x 50 mL + 1 x 3 mL padrão de Triglicerídeos
Protocolo de Automação – PENTRA 400 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: Kovalent do Brasil Ltda. Rua Cristovão Sardinha, 110 Jardim Bom Retiro – São Gonçalo
Rev: 3 - 02/2011
General parameters Test Name Code Channel Release Modified on
Triglycerides TRIG # Enable App. Version #
Characteristics Pre-Dilution
Result
Sample Type Serum/Plasma Diluent Name Unit mg/dl
Number of Reagents Reagent 1 Factor Decimal postion 0
Reagent Incubation time (cycles) Manual Patient Validation
Reagent short name Reagent number
TRIR #
Linearity Correlation
On Board Stability 28 Low limit High limit Slope Intercept
1.000 1000.000 1.0000 0.0000
# Cassette
Delta Check
Automatic Rerun Delta Check Validity Absolute Variation Relative Variation
Post Dilution
Dilution Factor 2.0 Reference Range
Man/Default Woman Child
Post Concentration Low Check 0
Concentration Factor High Check 200
Calibration parameters Test Name Code Channel Checks
Triglycerides TRIG # Reagent Limit Absorbance Check
Pre-Dilution Reagent Range Low
Type Calibrator Diluent
Reagent Range High
Factor 1 Factor 2 Factor 3 Factor 4 Reagent Blank Limit Absorbance Check
Factor 5 Factor 6 Factor 7 Factor 8 Blank Range – Low Limit
Blank Range – High Limit
Calibration
Calibration Mode Slope Avg Validitiy Control Required
On Request
Level 1 Control Used
Time Validity
Calibration Factor *
Interval Time Unit
Runs 2 # Days
Deviation % 5.0
Calibrator Used
Analysis parameters Test Name Code Channel
Triglycerides TRIG #
Cleaner Wavelength (nm) Blank
Cleaner Solution
H2O Primary Wavelength 505
Reagent Blank H2O
Before Secondary Wavelength 700
After
Analysis Sequence Mixing Speed
Cycle Reagent Needle Volume (µl) Sample Needle Volume (µl) H2O Vol (µl) 70
1 R1 290.0 SAMPLE 3.0 10.0
Rev: 3 - 02/2011
Calculation parameters Test Name Code Channel
Triglycerides TRIG #
Correlation Factor Reaction Direction Sample Limit Check
Slope 1.0000 Reaction Direction Check Sample limit ( O.D.)
Intercept 0.0000 Reaction Direction Increase Sample limit cycle
Definition
Calculation Type Endpoint
Reaction limit Check First Reading Last Reading
Reaction limit Absorbance
Cycle 0 Cycle 50
Cycle
Unit parameters
Test Name Triglycerides
Code TRIG
Channel #
Unit Conversion Factor
mg/dl 1.0000
Modified On
# Input by user * Calculated by the analyser **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
Capacidade Fixação de Ferro Insaturado - UIBC Referência Apresentação
3050050K R1 2 x 20 mL + R2 1 x 10 mL
3050075K R1 3 x 20 mL + R2 1 x 15 mL
Protocolo de Automação – PENTRA 400 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: Kovalent do Brasil Ltda. Rua Cristovão Sardinha, 110 Jardim Bom Retiro – São Gonçalo
General parameters Test Name Code Channel Release Modified on
UIBC UIBC # Enable App. Version #
Characteristics Pre-Dilution
Result
Sample Type Serum/Plasma Diluent Name Unit µg/dl
Number of Reagents Reagent 2 Factor Decimal postion 0
Reagent Incubation time (cycles) Manual Patient Validation
Reagent short name Reagent number
UIB #
Linearity Correlation
On Board Stability 28 Low limit High limit Slope Intercept
65.0000 750.000 1.0000 0.0000
# Cassette
Delta Check
Automatic Rerun Delta Check Validity Absolute Variation Relative Variation
Post Dilution
Dilution Factor 3.0 Reference Range
Man/Default Woman Child
Post Concentration Low Check 120.000
Concentration Factor High Check 470.000
Calibration parameters Test Name Code Channel Checks
UIBC UIBC # Reagent Limit Absorbance Check
Pre-Dilution Reagent Range Low
Type Calibrator Diluent
Reagent Range High
Factor 1 Factor 2 Factor 3 Factor 4 Reagent Blank Limit Absorbance Check
Factor 5 Factor 6 Factor 7 Factor 8 Blank Range – Low Limit
Blank Range – High Limit
Calibration
Calibration Mode Slope Avg Validitiy Control Required
On Request
Level 1 Control Used
Time Validity
Calibration Factor *
Interval Time Unit
Runs 2 # Days
Deviation % 5.0
Calibrator Used
Analysis parameters Test Name Code Channel
UIBC UIBC #
Cleaner Wavelength (nm) Blank
Cleaner Solution
H2O Primary Wavelength 600
Reagent Blank H2O
Before Secondary Wavelength 700
After
Analysis Sequence Mixing Speed
Cycle Reagent Needle Volume (µl) Sample Needle Volume (µl) H2O Vol (µl) 70
1 R1 200.0 SAMPLE 15.0 10.0
15 R2 50.0 10.0
Calculation parameters Test Name Code Channel
UIBC UIBC #
Correlation Factor Reaction Direction Sample Limit Check
Slope 1.0000 Reaction Direction Check Sample limit ( O.D.)
Intercept 0.0000 Reaction Direction Increase Sample limit cycle
Definition
Calculation Type Endpoint
Reaction limit Check First Reading Last Reading
Reaction limit Absorbance
Cycle 14 Cycle 55
Cycle 1
Unit parameters
Test Name UIBC
Code #
Channel #
Unit Conversion Factor
µg/dl 1.0000
Modified On
# Input by user * Calculated by the analyser **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
Rev: 3 - 02/2011
Uréia UV Referência Apresentação
1070250K R1 1 x 200 mL + R2 1 x 50 mL + 1 x 3 mL Padrão de Uréia
1070500K R1 2 x 200 mL + R2 1 x 100 mL + 1 x 3 mL Padrão de Uréia
1070250T R1 10 x 20 mL + R2 2 x 25 mL + 1 x 3 mL Padrão de Uréia
1070200M R1 4 x 40 mL + R2 4 x 10 mL + 1 x 3 mL Padrão de Uréia
Protocolo de Automação – PENTRA 400 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: Kovalent do Brasil Ltda. Rua Cristovão Sardinha, 110 Jardim Bom Retiro – São Gonçalo
Rev: 3 - 02/2011
General parameters Test Name Code Channel Release Modified on
Urea UREA # Enable App. Version #
Characteristics Pre-Dilution
Result
Sample Type Serum/Plasma Diluent Name Unit mg/dl
Number of Reagents Reagent 2 Factor Decimal postion 0
Reagent Incubation time (cycles) Manual Patient Validation
Reagent short name Reagent number
URER #
Linearity Correlation
On Board Stability 28 Low limit High limit Slope Intercept
2.00 300.00 1.0000 0.0000
# Cassette
Delta Check
Automatic Rerun Delta Check Validity Absolute Variation Relative Variation
Post Dilution
Dilution Factor 3.0 Reference Range
Man/Default Woman Child
Post Concentration Low Check 17.00
Concentration Factor High Check 43.00
Calibration parameters Test Name Code Channel Checks
Urea UREA # Reagent Limit Absorbance Check
Pre-Dilution Reagent Range Low -0.2000
Type Calibrator Diluent
Reagent Range High 1.8000
Factor 1 Factor 2 Factor 3 Factor 4 Reagent Blank Limit Absorbance Check
Factor 5 Factor 6 Factor 7 Factor 8 Blank Range – Low Limit -0.0400
Blank Range – High Limit 1.8000
Calibration
Calibration Mode Slope Avg Validitiy Control Required
On Request
Level 1 Control Used
Time Validity
Calibration Factor *
Interval Time Unit
Runs 2 # Days
Deviation % 5.0
Calibrator Used
Analysis parameters Test Name Code Channel
Urea UREA #
Cleaner Wavelength (nm) Blank
Cleaner Solution
H2O Primary Wavelength 340
Reagent Blank H2O
Before Secondary Wavelength 405
After
Analysis Sequence Mixing Speed
Cycle Reagent Needle Volume (µl) Sample Needle Volume (µl) H2O Vol (µl) 80
1 R1 200.0 SAMPLE 2.00 10.0
15 R2 50.0 10.0
Rev: 3 - 02/2011
Calculation parameters Test Name Code Channel
Urea UREA #
Correlation Factor Reaction Direction Sample Limit Check
Slope 1.0000 Reaction Direction Check Sample limit ( O.D.)
Intercept 0.0000 Reaction Direction Decrease Sample limit cycle
Definition
Calculation Type Kinetic
Reaction limit Check First Reading Last Reading
Reaction limit Absorbance
Cycle 20 Cycle 25
Cycle
Unit parameters
Test Name Urea
Code UREA
Channel #
Unit Conversion Factor
mg/dl 1.0000
Modified On
# Input by user * Calculated by the analyser **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.