Traceability and Uncertainty

DiaSys TruCal U Multicalibrator

Cat. No. 5 9100

DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany) Apr 09

Traceability And Uncertainty:

Albumin FS Product Code 1 0220

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Albumin Bromcresol green (BCG) method ERM-DA470 4,14%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure

Value Uncertainty

ERM-DA470

3,97 0,08

g/dL

DiaSys Albumin reagent, Measurement at Hitachi 911 analyzer DiaSys Master calibrator 4,38 0,15 Lot. 8713
Evaluating the accuracy of DiaSys Albumin procedure by validating reference material ERM-DA470; Adjustment of DiaSys Master calibrator

g/dL

DiaSys Master calibrator Lot. 8713 DiaSys Albumin reagent, Measurement at Hitachi 911 analyzer

Ajusted master calibrator value 4,49 0,15 g/dL

TruCal U product calibrator

4,71 0,06

g/dL

4,71 0,19 4,14%

g/dL

2009-04-17
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

Albumin FSC Product Code 2 0250

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Albumin

Bromcresol green (BCG) method; Concentrated reagent ERM-DA470 2,29%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure

Value Uncertainty

ERM-DA470

3,97 0,08

g/dL

DiaSys Albumin FSC reagent, Measurement at Olympus AU 600 analyzer DiaSys Master calibrator 4,29 0,02 Lot. 8713
Evaluating the accuracy of DiaSys Albumin FSC procedure on Olympus AU 600 analyzer by validating reference material ERMDA470; Adjustment of DiaSys Master calibrator

g/dL

DiaSys Master calibrator Lot. 8713 DiaSys Albumin FSC reagent, Measurement at Olympus AU 640 analyzer

Ajusted master calibrator value 4,49 0,02 g/dL

TruCal U product calibrator

4,64 0,04

g/dL

4,64 0,11 2,29%

g/dL

2009-04-17
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

Alkaline phosphatase FS DGKC Product Code 1 0401

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Alkaline phosphatase (ALP) DGKC recommended procedure

Original formulation DGKC (Molar extinction coefficient 405 nm = 11,2 L * mmol * cm ), 37 C

-1 -1

4,86%
1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material
Molar extinction coefficient according to DGKC recommendation

Procedure

Value Uncertainty

DiaSys ALP DGKC reagent, Manual Measurement

DiaSys Master calibrator 493 22,8 Lot. 8713 DiaSys ALP DGKC reagent, Measurement at Hitachi 911 analyzer U/L

TruCal U product calibrator

500 7,6

U/L

500 24,3 4,86%

U/L

2009-04-17
Date

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber

DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

Traceability & Uncertainty Certificate

Version 1 from 2007

Traceability And Uncertainty:

Alkaline phosphatase FS IFCC 37 C Product Code 1 0441

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Alkaline phosphatase (ALP) IFCC recommended procedure

Original formulation IFCC (Molar extinction coefficient 405 nm = 11,2 L * mmol * cm ), 37 C

-1 -1

5,93%
1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material
Molar extinction coefficient according to IFCC recommendation

Procedure

Value Uncertainty

DiaSys ALP IFCC reagent, Manual Measurement

DiaSys Master calibrator 245 14,3 Lot. 8713 DiaSys ALP IFCC reagent, Measurement at Hitachi 911 analyzer U/L

TruCal U product calibrator

244 2,76

U/L

244 14,5 5,93%

U/L

2009-04-17
Date

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber

DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

Traceability & Uncertainty Certificate

Version 1 from 2007

Traceability And Uncertainty:

ALAT (GPT) (IFCC mod.) Product Code 1 2701

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U

Alanine Aminotransferase (ALAT) / Glutamic Pyruvic Transaminase (GPT) IFCC recommended procedure, with Pyridoxal-5-Phosphate (2 5010)
Original formulation IFCC (Molar extinction coefficient 340 nm = 6,3 L * mmol-1 * cm-1), 37 C

2,01%
1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure

Value Uncertainty

Molar extinction coefficient according to original IFCC procedure Original ALAT IFCC formulation, Manual measurement at INSTAND e.V. DiaSys Master calibrator 80,1 0,85 Lot. 8713
Evaluating the accuracy of DiaSys ALAT IFCC procedure in human serum; Adjustment of DiaSys Master calibrator

U/L

DiaSys Master calibrator Lot. 8713

Uncertainty of value transfer from method comparison original IFCC procedure vs. DiaSys ALAT IFCC procedure, based on PassingBablock Regression

Ajusted master calibrator value 88,6 0,53 U/L

y = 1,000 r = 0,999

Passing-Bablock Regression -0,200 X

U/L

DiaSys Master calibrator Lot. 8713 DiaSys ALAT IFCCreagent, Measurement at Hitachi 911 analyzer

Ajusted master calibrator value 88,4 0,73 U/L

TruCal U product calibrator

89,3 1,52

U/L

89,3 1,79 2,01%

U/L

2009-04-17
DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore no been signed by hand. Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

ALAT (GPT) FSC (IFCC mod.) Product Code 2 2705

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U

Alanine Aminotransferase (ALAT) / Glutamic Pyruvic Transaminase (GPT)

IFCC recommended procedure, with Pyridoxal-5-Phosphate (2 5010); Concentrated reagent Original formulation IFCC (Molar extinction coefficient 340 nm = 6,3 L * mmol-1 * cm-1), 37 C

#BEZUG!
1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material
Molar extinction coefficient according to original IFCC procedure

Procedure

Value Uncertainty

Original ALAT IFCC formulation, Manual measurement at INSTAND e.V. DiaSys Master calibrator 80,1 0,85 Lot. 8713
Evaluating the accuracy of DiaSys ALAT IFCC procedure in human serum; Adjustment of DiaSys Master calibrator

U/L

DiaSys Master calibrator Lot. 8713

Uncertainty of value transfer from method comparison original IFCC procedure vs. DiaSys ALAT IFCC procedure, based on Passing-Bablock Regression

Ajusted master calibrator value 88,6 0,53 U/L

Passing-Bablock Regression y = 1,000 X -0,200 r = 0,999 Ajusted master calibrator value 88,4 0,73 U/L

U/L

DiaSys Master calibrator Lot. 8713

Uncertainty of value transfer from method comparison DiaSys ALAT IFCC procedure on Hitachi 911 vs. DiaSys ALAT IFCC FSC on Olympus AU 600 procedure, based on Passing-Bablock Regression; n=73

Passing-Bablock Regression -0,409 y = 0,999 X r = 1,000 No ajusted of master calibrator value

U/L

DiaSys Master calibrator 88,4 0,73 Lot. 8713 DiaSys ALAT IFCC FSC reagent, Measurement at Olympus AU 640 analyzer TruCal U product calibrator U/L

88,0 2,00

U/L

88,0 2,21 2,51%

U/L

2009-04-17
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

ALAT (GPT) (IFCC mod.) Product Code 1 2701

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U

Alanine Aminotransferase (ALAT) / Glutamic Pyruvic Transaminase (GPT) Modified IFCC procedure, without Pyridoxal-5-Phosphate
Modified IFCC formulation (Molar extinction coefficient 340 nm = 6,3 L * mmol * cm ), 37 C
-1 -1

1,74%
1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure

Value Uncertainty

Molar extinction coefficient

DiaSys ALAT reagent, Manual Measurement

DiaSys Master calibrator 85,7 0,51 Lot. 8713 DiaSys ALAT reagent, Measurement at Hitachi 911 analyzer U/L

TruCal U product calibrator

88,0 1,44

U/L

88,0 1,53 1,74%

U/L

2009-04-17
Date

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber

DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

Traceability & Uncertainty Certificate

Version 1 from 2007

Traceability And Uncertainty:

ASAT (GOT) (IFCC mod.) Product Code 1 2601

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U

Asparte Aminotransferase (ASAT) / Glutamic Oxaloacetate Transaminase (GOT) IFCC recommended procedure, with Pyridoxal-5-Phosphate (2 5010)
Original formulation IFCC (Molar extinction coefficient 340 nm = 6,3 L * mmol-1 * cm-1), 37 C

2,02%
1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material
Molar extinction coefficient according to original IFCC procedure

Procedure

Value Uncertainty

Original ASAT IFCC formulation, Manual measurement at INSTAND e.V. DiaSys Master calibrator 89,3 1,42 Lot. 8713
Evaluating the accuracy of DiaSys ASAT IFCC procedure in human serum; Adjustment of DiaSys Master calibrator

U/L

DiaSys Master calibrator Lot. 8713

Uncertainty of value transfer from method comparison original IFCC procedure vs. DiaSys ASAT IFCC procedure, based on Passing-Bablock Regression

Ajusted master calibrator value 93,2 0,54 U/L

Passing-Bablock Regression -0,200 y = 1,000 X r = 1,000 Ajusted master calibrator value 93,0 0,54 U/L

U/L

DiaSys Master calibrator Lot. 8713 DiaSys ASAT IFCC reagent, Measurement at Hitachi 911 analyzer

TruCal U product calibrator

98,7 1,23

U/L

98,7 1,99 2,02%

U/L

2009-04-17
DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

ASAT (GOT) FSC (IFCC mod.) Product Code 2 2605

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U

Asparte Aminotransferase (ASAT) / Glutamic Oxaloacetate Transaminase (GOT)

IFCC recommended procedure, with Pyridoxal-5-Phosphate (2 5010); Concentrated reagent Original formulation IFCC (Molar extinction coefficient 340 nm = 6,3 L * mmol-1 * cm-1), 37 C

#BEZUG!
1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material
Molar extinction coefficient according to original IFCC procedure

Procedure

Value Uncertainty

Original ASAT IFCC formulation, Manual measurement at INSTAND e.V. DiaSys Master calibrator 89,3 1,42 Lot. 8713
Evaluating the accuracy of DiaSys ASAT IFCC procedure in human serum; Adjustment of DiaSys Master calibrator

U/L

DiaSys Master calibrator Lot. 8713

Uncertainty of value transfer from method comparison original IFCC procedure vs. DiaSys ASAT IFCC procedure, based on Passing-Bablock Regression

Ajusted master calibrator value 93,2 0,54 U/L

Passing-Bablock Regression y = 1,000 X -0,200 r = 1,000 Ajusted master calibrator value 93,0 0,54 U/L

U/L

DiaSys Master calibrator Lot. 8713

Uncertainty of value transfer from method comparison DiaSys ASAT IFCC procedure on Hitachi 911 vs. DiaSys ASAT IFCC FSC on Olympus AU 600 procedure, based on Passing-Bablock Regression; n=73

Passing-Bablock Regression y = 0,967 X 2,989 r = 0,999 No ajusted of master calibrator value

U/L

DiaSys Master calibrator 93,0 0,54 Lot. 8713 DiaSys ASAT IFCC FSC reagent, Measurement at Olympus AU 640 analyzer TruCal U product calibrator U/L

95,7 2,62

U/L

95,7 3,03 3,17%

U/L

2009-04-17
Date

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber

DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

Traceability & Uncertainty Certificate

Version 1 from 2007

Traceability And Uncertainty:

ASAT (GOT) (IFCC mod.) Product Code 1 2601

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U

Asparte Aminotransferase (ASAT) / Glutamic Oxaloacetate Transaminase (GOT) Modified IFCC procedure, without Pyridoxal-5-Phosphate
Modified IFCC formulation (Molar extinction coefficient 340 nm = 6,3 L * mmol * cm ), 37 C
-1 -1

1,98%
1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure

Value Uncertainty

Molar extinction coefficient

DiaSys AST reagent, Manual Measurement

DiaSys Master calibrator 78,4 0,74 Lot. 8713 DiaSys AST reagent, Measurement at Hitachi 911 analyzer U/L

TruCal U product calibrator

90,1 1,57

U/L

90,1 1,78 1,98%

U/L

2009-04-17
Date

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber

DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

Traceability & Uncertainty Certificate

Version 1 from 2007

Traceability And Uncertainty:

-Amylase CC FS Product Code 1 0501

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U -Amylase

EPS-G7 method, similar to IFCC recommended procedure

Original formulation IFCC (Molar extinction coefficient 405 nm = 11,2 L * mmol * cm ), 37 C
-1 -1

4,76%
1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material
Molar extinction coefficient according to IFCC recommendation

Procedure

Value Uncertainty

DiaSys -Amylase CC reagent, Manual Measurement DiaSys Master calibrator 206 9,4 Lot. 8713
Uncertainty of value transfer from method comparison IFCC procedure vs. DiaSys -Amylase CC procedure, based on PassingBablock Regression

U/L

Passing-Bablock Regression -2,455 y = 0,964 X r = 0,998 Ajusted master calibrator value 201 11,4 U/L

U/L

DiaSys Master calibrator Lot. 8713 DiaSys -Amylase CC reagent, Measurement at Hitachi 911 analyzer

TruCal U product calibrator

199 2,73

U/L

199 9,5 4,76%

U/L

2009-04-17
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

-Amylase FS CNP-G3 Product Code 1 0510

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U -Amylase CNP-G3 method

Molar extinction coefficient 405 nm = 11,2 L * mmol-1 * cm-1, 37 C 4,89%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure

Value Uncertainty

Molar extinction coefficient

DiaSys -Amylase CNP-G3 reagent, Manual Measurement DiaSys Master calibrator 241 11,5 Lot. 8713 DiaSys -Amylase CNP-G3 reagent, Measurement at Hitachi 911 analyzer U/L

TruCal U product calibrator

238 2,69

U/L

238 11,6 4,89%

U/L

2009-04-17
Date

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber

DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

Traceability & Uncertainty Certificate

Version 1 from 2007

Traceability And Uncertainty:

Pancreatic amylase CC FS Product Code 1 0551

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Pancreatic Amylase

EPS-G7 method, immunoinhibition of salivary amylase Molar extinction coefficient 405 nm = 11,2 L * mmol-1 * cm-1, 37 C 5,38%
1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure

Value Uncertainty

Molar extinction coefficient

DiaSys Pancreatic-Amylase reagent, Manual Measurement DiaSys Master calibrator 150 7,9 Lot. 8713 DiaSys Pancreatic-Amylase reagent, Measurement at Hitachi 911 analyzer U/L

TruCal U product calibrator

128 1,4

U/L

128 6,9 5,38%

U/L

2009-04-17
Date

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber

DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

Traceability & Uncertainty Certificate

Version 1 from 2007

Traceability And Uncertainty:

Bile acids Product Code 1 2212

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Bile acids Colorimetric test with endpoint determination Primary reference material 2,22%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure

Value Uncertainty

Bile Acid Master Standard, based on primary material

Master Bile acid reagent

DiaSys Bile acids product standard Lot. 9163

35 0,45

mol/l

DiaSys Bile acids reagent, Measurement at Selectra XL analyzer DiaSys Master calibrator 122 1,58 Lot. 8713 DiaSys Bile acids reagent, Measurement at Hitachi 911 analyzer mol/l

TruCal U product calibrator

118 1,48

mol/l

118 2,61 2,22%

mol/l

2009-04-17
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

Bilirubin Auto Total FS Product Code 1 0811

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Bilirubin total DCA Jendrassik Grof 2,56%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure

Value Uncertainty

Theoretical factor according to Jendrassik L, Grf P. Vereinfachte photometrische Methoden zur Bestimmung des Blutbilirubins. Biochem Zeitschrift 1938;297:82-9

DiaSys Bilirubin Jendrassik Grof FS reagent ( 1 0849), manual measurement DiaSys Master calibrator 4,13 0,05 Lot. 8713 DiaSys Bilirubin Auto Total reagent, Measurement at Hitachi 911 analyzer mg/dL

TruCal U product calibrator

3,96 0,09

mg/dL

3,96 0,10 2,56%

mg/dL

2009-04-17
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

Bilirubin Auto Direct FS Product Code 1 0821

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Bilirubin direct DCA Jendrassik Grof 2,29%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure

Value Uncertainty

Theoretical factor according to Jendrassik L, Grf P. Vereinfachte photometrische Methoden zur Bestimmung des Blutbilirubins. Biochem Zeitschrift 1938;297:82-9

DiaSys Bilirubin Jendrassik Grof FS reagent ( 1 0849), manual measurement DiaSys Master calibrator 1,89 0,03 Lot. 8713 DiaSys Bilirubin Auto Direct reagent, Measurement at Hitachi 911 analyzer mg/dL

TruCal U product calibrator

1,67 0,03

mg/dL

1,67 0,04 2,29%

mg/dL

2009-04-17
Date

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber

DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

Traceability & Uncertainty Certificate

Version 1 from 2007

Attachment No. 1 (Form) SOP No. 27 Traceability and Uncertainty

Traceability And Uncertainty Certificate

Version 1 from 2007 Page 16 of 21

Traceability And Uncertainty:

Calcium P FS Product Code 1 1181

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Calcium Phosphonazo Atomic absorption Spectrometry 1,63%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure

Value Uncertainty

Atomic absorption Spectrometry, measurement at INSTAND e.V. DiaSys Master calibrator 14,7 0,08 Lot. 8713 DiaSys Calcium P reagent, Measurement at Hitachi 911 analyzer mg/dL

Target values SRM 956b Level 1, Level 2, Level 3 Level 1: Level 2: Level 3:
Evaluating the accuracy of DiaSys Calcium P procedure in human serum by validating reference material; Adjustment of DiaSys Master calibrator

Results 12,14 0,225 10,16 0,136 8,198 0,276 mg/dL mg/dL mg/dL Mean

Deviation 2,67% 3,21% 3,63% 3,17%

11,82 0,08 9,844 0,060 7,911 0,052

DiaSys Master calibrator Lot. 8713 DiaSys Calcium P reagent, Measurement at Hitachi 911 analyzer

Ajusted master calibrator value 14,2 0,08 mg/dL

TruCal U product calibrator

12,4 0,19

mg/dL

12,4 0,20 1,63%

mg/dL

2009-04-17
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

Calcium CPC FS Product Code 1 1121

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Calcium o-Cresolphthalein complexone method Atomic absorption Spectrometry 0,97%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure

Value Uncertainty

Atomic absorption Spectrometry, measurement at INSTAND e.V. DiaSys Master calibrator 14,7 0,08 Lot. 8713 DiaSys Calcium CPC reagent, Measurement at Hitachi 911 analyzer mg/dL

Target values SRM 956b Level 1, Level 2, Level 3 Level 1: Level 2: Level 3:
Evaluating the accuracy of DiaSys Calcium CPC procedure in human serum by validating reference material; Adjustment of DiaSys Master calibrator

Results 11,95 0,178 9,71 0,071 7,57 0,085 mg/dL mg/dL mg/dL Mean

Deviation 1,11% -1,38% -4,30% -1,52%

11,82 0,08 9,844 0,060 7,911 0,052

DiaSys Master calibrator Lot. 8713 DiaSys Calcium CPC reagent, Measurement at Hitachi 911 analyzer

No ajustment of master calibrator value 14,7 0,08 mg/dL

TruCal U product calibrator

12,5 0,10

mg/dL

12,5 0,12 0,97%

mg/dL

2009-04-17
DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

Calcium CPC FSC Product Code 2 1145

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Calcium

o-Cresolphthalein complexone method; Concentrated reagent Atomic absorption Spectrometry 0,88%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure
Atomic absorption Spectrometry, measurement at INSTAND e.V.

Value Uncertainty

DiaSys Master calibrator 14,7 0,08 Lot. 8713 DiaSys Calcium CPC reagent, Measurement at Hitachi 911 analyzer mg/dL

SRM 956b Level 1, Level 2, Level 3

Level 1: Level 2: Level 3:

Evaluating the accuracy of DiaSys Calcium CPC procedure in human serum by validating reference material; Adjustment of DiaSys Master calibrator

Target values 11,82 0,08 9,844 0,060 7,911 0,052

Results 11,95 0,178 9,71 0,071 7,57 0,085

Deviation mg/dL mg/dL mg/dL Mean 1,11% -1,38% -4,30% -1,52%

DiaSys Master calibrator Lot. 8713 DiaSys Calcium CPC FSC reagent, Measurement at Olympus AU 600 analyzer

No ajustment of master calibrator value 14,7 0,08 mg/dL

SRM 956b Level 1, Level 2, Level 3

Level 1: Level 2: Level 3:

Evaluating the accuracy of DiaSys Calcium CPC FSC procedure in human serum by validating reference material; Adjustment of DiaSys Master calibrator

Target values 11,82 0,08 9,844 0,060 7,911 0,052

Results 11,50 0,172 9,19 0,109 7,15 0,091

Deviation mg/dL mg/dL mg/dL Mean -2,71% -6,64% -9,62% -6,32%

DiaSys Master calibrator

Ajustment of master calibrator value 13,78 0,12 mg/dL

DiaSys Calcium CPC FSC reagent, Measurement at Olympus AU 640 analyzer

TruCal U product calibrator

11,6 0,08

mg/dL

11,6 0,10 0,88%

mg/dL

2009-04-17
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

Calcium AS FS Product Code 1 1130

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Calcium Arsenazo III Atomic absorption Spectrometry 1,21%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure
Atomic absorption Spectrometry, measurement at INSTAND e.V.

Value Uncertainty

DiaSys Master calibrator 14,7 0,08 Lot. 8713 12,172 DiaSys Calcium Arsenazo reagent, Measurement at Hitachi 911 analyzer 0,2531 10,254 0,1279 8,199444 0,087075 mg/dL

SRM 956b Level 1, Level 2, Level 3

Level 1: Level 2: Level 3:

Evaluating the accuracy of DiaSys Calcium Arsenazo procedure in human serum by validating reference material; Adjustment of DiaSys Master calibrator

Target values 11,82 0,08 9,844 0,060 7,911 0,052

Results 12,17 0,253 10,25 0,128 8,199 0,087

Deviation mg/dL mg/dL mg/dL Mean 2,98% 4,16% 3,65% 3,59%

DiaSys Master calibrator Lot. 8713 DiaSys Calcium Arsenazo reagent, Measurement at Hitachi 911 analyzer

Ajusted master calibrator value 14,2 0,08 mg/dL

TruCal U product calibrator

12,1 0,13

mg/dL

12,1 0,15 1,21%

mg/dL

2009-04-17
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

Cholinesterase FS Product Code 1 1401

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Cholinesterase (CHE)

Butyrylthiocholine method (Optimized DGKC formulation)

Original formulation DGKC (Molar extinction coefficient 405 nm = 11,2 L * mmol-1 * cm-1), 37 C

6,62%
1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure

Value Uncertainty

Molar extinction coefficient according to DGKC recommendation

DiaSys CHE reagent, Manual Measurement

DiaSys Master calibrator 6770 439,3 Lot. 8713

Uncertainty of value transfer from method comparison DGKC procedure vs. DiaSys CHE procedure, based on PassingBablock Regression

U/L

y = 0,948 r = 0,994

Passing-Bablock Regression 89 x +

U/L

DiaSys Master calibrator Lot. 8713 DiaSys CHE reagent, Measurement at Hitachi 911 analyzer

Ajusted master calibrator value 6502 421,9 U/L

TruCal U product calibrator

6482 84,5

U/L

6482 429 6,62%

U/L

2009-04-17
Date

This certificate of traceability & uncertainty is a computer printout and has therefore not bee signed by hand. Sign.: Benno Weber

DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

Traceability & Uncertainty Certificate

Version 1 from 2007

Traceability And Uncertainty:

Cholesterol FS Product Code 1 1300

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Cholesterol CHOD-PAP - Trinder reaction

Gas-Chromatography isotope dilution spectrometry 1,21%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure
Gas-Chromatography isotope dilution spectrometry, measurement at INSTAND e.V.

Value Uncertainty

DiaSys Master calibrator 149 0,8 Lot. 8713 DiaSys Cholesterol 5 min reagent, Measurement at Hitachi 911 analyzer mg/dL

SRM 1951b Level 1 and Level 2

Level 1: Level 2:

Target values 185,76 0,55 266,58 0,84

Results 191,70 1,97 275,39 1,94

Deviation mg/dL mg/dL Mean 3,20% 3,30% 3,25%

Evaluating the accuracy of DiaSys Cholesterol procedure in human serum by validating reference material; Adjustment of DiaSys Master calibrator

DiaSys Master calibrator Lot. 8713 DiaSys Cholesterol 10 min reagent, Measurement at Hitachi 911 analyzer

Ajusted master calibrator value 144 1,02 mg/dL

TruCal U product calibrator

146 1,58

mg/dL

146 1,76 1,21%

mg/dL

2009-04-17
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

Cholesterol FSC Product Code 2 1300

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Cholesterol

CHOD-PAP - Trinder reaction; Concentrated reagent Gas-Chromatography isotope dilution spectrometry 1,04%
1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure
Gas-Chromatography isotope dilution spectrometry, measurement at INSTAND e.V.

Value Uncertainty

DiaSys Master calibrator 149 0,8 Lot. 8713 DiaSys Cholesterol 5 min reagent, Measurement at Hitachi 911 analyzer mg/dL

SRM 1951b Level 1 and Level 2

Level 1: Level 2:

Target values 185,76 0,55 266,58 0,84

Results 191,70 1,97 275,39 1,94

Deviation mg/dL mg/dL Mean 3,20% 3,30% 3,25%

Evaluating the accuracy of DiaSys Cholesterol procedure in human serum by validating reference material; Adjustment of DiaSys Master calibrator

DiaSys Master calibrator Lot. 8713 DiaSys Cholesterol FSC reagent, Measurement at Olympus AU 600 analyzer

Ajusted master calibrator value 144 1,02 mg/dL

SRM 1951b Level 1 and Level 2

Level 1: Level 2:

Target values 185,76 0,55 266,58 0,84

Results 186,50 1,30 267,18 1,55

Deviation mg/dL mg/dL Mean 0,40% 0,23% 0,31%

Evaluating the accuracy of DiaSys Cholesterol FSC procedure in human serum by validating reference material; Adjustment of DiaSys Master calibrator

DiaSys Master calibrator Lot. 8713 DiaSys Cholesterol FSC reagent, Measurement at Olympus AU 640 analyzer

No ajustment of master calibrator value 144 1,02 mg/dL

TruCal U product calibrator

141 1,26

mg/dL

141 1,47 1,04%

mg/dL

2009-04-17
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

Free cholesterol FS Product Code 1 1360

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Non-esterified cholesterol CHOD-PAP - Trinder reaction

Gas-Chromatography isotope dilution spectrometry 3,36%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure
Gas-Chromatography isotope dilution spectrometry, measurement at INSTAND e.V.

Value Uncertainty

DiaSys Cholesterol Master standard I. Ref. 11/07

201 1,12

mg/dL

DiaSys Free Cholesterol reagent, Measurement at Hitachi 911 analyzer DiaSys Master calibrator 28,4 0,65 Lot. 8713 DiaSys Free Cholesterol reagent, Measurement at Hitachi 911 analyzer mg/dL

TruCal U product calibrator

28,0 0,67

mg/dL

28,0 0,94 3,36%

mg/dL

2009-04-17
Date

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber

DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

Traceability & Uncertainty Certificate

Version 1 from 2007

Traceability And Uncertainty:

CK-NAC FS Product Code 1 1601

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Creatine Kinase (CK) DGKC / IFCC recommended procedure

Original formulation IFCC (Molar extinction coefficient 340 nm = 6,3 L * mmol-1 * cm-1), 37 C

3,53%
1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material
Molar extinction coefficient according to original IFCC procedure

Procedure

Value Uncertainty

Original CK IFCC formulation, Manual measurement at INSTAND e.V. DiaSys Master calibrator 244,0 4,66 Lot. 8713
Evaluating the accuracy of DiaSys CK-NAC (11601) procedure in human serum; Adjustment of DiaSys Master calibrator

U/L

DiaSys Master calibrator Lot. 8713

Uncertainty of value transfer from method comparison original IFCC procedure vs. DiaSys CKNAC (11601) procedure, based on Passing-Bablock Regression

Ajusted master calibrator value 244,8 2,98 U/L

Passing-Bablock Regression -0,249 y = 0,997 X r = 0,999 Ajusted master calibrator value 243,8 2,97 U/L

U/L

DiaSys Master calibrator Lot. 8713 DiaSys CK-NAC reagent (11601), Measurement at Hitachi 911 analyzer

TruCal U product calibrator

241 7,14

U/L

241 8,50 3,53%

U/L

2009-04-17
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

CK-MB FS Product Code 1 1651

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Creatinekinase isoenzyme MB (CK-MB)

Based on DGKC / IFCC recommendation, immunoinhibition method Molar extinction coefficient 340 nm = 6,3 L * mmol-1 * cm-1, 37 C 2,67%
1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure

Value Uncertainty

Molar extinction coefficient according to IFCC recommendation DiaSys CK-MB reagent (11651), Measurement at Epos analyzer (R2 start, factor calculation) DiaSys Master calibrator 76,72 Lot. 8713 Method comparison for DiaSys CK-MB reagent (11651), n=42: Measurement at Epos analyzer (R2 start, factor calculation) against Hitachi analyzer calibrated with DiaSys Master calibrator Lot 8713 76,72 U/L U/L

y = 0,904x + 0,586 U/L

Adjustment of DiaSys master calibrator according to the results from method comparison

83,50

U/L

DiaSys CK-MB reagent (11651), Measurement at Hitachi 911 analyzer

TruCal U product calibrator

100 2,66

U/L

100 2,66 2,67%

U/L

2008-05-21
Date

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber

DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

Traceability & Uncertainty Certificate

Version 2 from 2008

Traceability And Uncertainty:

CK-MB FS Product Code 1 1641

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Creatinekinase isoenzyme MB (CK-MB)

Based on IFCC recommendation, immunoinhibition method DiaSys master calibrator related to ERM - AD455/IFCC 6,55 %

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure

Value Uncertainty

DiaSys Master calibrator Lot 8713 related to ERM AD455/IFCC

101 3,96% 99,4 1,59%

% %

Uncertainty of value transfer

3,09

Uncertainty of method comparison to Roche CKMB method

5,77

TruCal U product calibrator

90,3 6,55

2010-05-12
Date

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber

Traceability And Uncertainty:

Chloride FS Product Code 1 1200

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Chloride Thiocyanate method Coulometry 1,28%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure

Value Uncertainty

Coulometry, measurement at INSTAND e.V.

DiaSys Master calibrator 107 0,6 Lot. 8713 DiaSys Chloride reagent, Measurement at Hitachi 911 analyzer mmol/L

SRM 956b Level 1, Level 2, Level 3

Level 1: Level 2: Level 3:

Evaluating the accuracy of DiaSys Cholride procedure in human serum by validating reference material; Adjustment of DiaSys Master calibrator

Target values 99,01 0,66 111,88 0,82 126,85 0,81

Results 96,14 1,55 104,01 3,40 116,61 3,07

Deviation mmol/L mmol/L mmol/L Mean -2,89% -7,04% -8,07% -6,00%

Target values of SRM 956b based on isotope dilution thermal ionization mass spectrometry (ID-TIMS)

DiaSys Master calibrator Lot. 8713 DiaSys Chloride reagent, Measurement at Hitachi 911 analyzer

No ajustment of master calibrator value 107 0,6 mmol/L

TruCal U product calibrator

105 1,2

mmol/L

105 1,3 1,28%

mmol/L

2009-04-17
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

Creatinin PAP FS Product Code 1 1759

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Creatinin Enzymatic PAP method

Gas-Chromatography isotope dilution spectrometry 1,40%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure
Gas-Chromatography isotope dilution spectrometry, measurement at INSTAND e.V.

Value Uncertainty

DiaSys Master calibrator 3,82 0,03 Lot. 8713 DiaSys Creatinin PAP reagent, Measurement at Hitachi 911 analyzer mg/dL

SRM 967 SRM 967 Level 1 and Level 2 Level 1: Level 2:

Target values 0,753 0,021 3,916 0,083

Results 0,719 0,018 3,801 0,025

Deviation mg/dL mg/dL Mean -4,53% -2,93% -3,73%

Evaluating the accuracy of DiaSys Creatinin PAP procedure in human serum by validating reference material; Adjustment of DiaSys Master calibrator

DiaSys Master calibrator Lot. 8713 DiaSys Creatinin PAP reagent, Measurement at Hitachi 911 analyzer

Ajusted master calibrator value 3,96 0,03 mg/dL

TruCal U product calibrator

4,13 0,05

mg/dL

4,13 0,06 1,40%

mg/dL

2009-04-17
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

Creatinin FS Product Code 1 1711

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Creatinin Jaffe method without compensation Gas-Chromatography isotope dilution spectrometry 1,90%
1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland

2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure
Gas-Chromatography isotope dilution spectrometry, measurement at INSTAND e.V.

Value Uncertainty

DiaSys Master calibrator 3,82 0,027 Lot. 8713 DiaSys Creatinin Jaffe reagent, Measurement at Hitachi 911 analyzer without compensation SRM 967 SRM 967 Level 1 and Level 2 Level 1: Level 2: Target values 0,753 0,021 3,916 0,083 Results 0,972 0,014 3,816 0,057 Deviation mg/dL mg/dL Mean
Evaluating the accuracy of DiaSys Creatinin Jaffe procedure in human serum by validating reference material; Adjustment of DiaSys Master calibrator

mg/dL

29,11% -2,56% 13,27%

DiaSys Master calibrator Lot. 8713 DiaSys Creatinin Jaffe reagent, Measurement at Hitachi 911 analyzer without compensation TruCal U product calibrator

No ajustment of master calibrator value 3,820 0,027 mg/dL

3,98 0,07

mg/dL

3,98 0,075 1,90%

mg/dL

2008-07-22
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

Creatinin FS Product Code 1 1711

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Creatinin Jaffe method with compensation Gas-Chromatography isotope dilution spectrometry 2,12%
1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure
Gas-Chromatography isotope dilution spectrometry, measurement at INSTAND e.V.

Value Uncertainty

DiaSys Master calibrator 3,82 0,027 Lot. 8713 DiaSys Creatinin Jaffe reagent, Measurement at Hitachi 911 analyzer without compensation SRM 967 SRM 967 Level 1 and Level 2
Evaluating the accuracy of DiaSys Creatinin Jaffe procedure in human serum by validating reference material and human serum samples; Adjustment of DiaSys Master calibrator

mg/dL

Level 1: Level 2:

Target values 0,753 0,021 3,916 0,083

Results 0,972 0,014 3,816 0,057

Deviation mg/dL mg/dL Mean 29,11% -2,56% 13,27%

Ajusted master calibrator value 4,294 0,030 mg/dL

DiaSys Master calibrator Lot. 8713

Evaluating the accuracy of DiaSys Creatinin Jaffe procedure in human serum by validating reference material; Adjustment of DiaSys Master calibrator

SRM 967 Level 1: Level 2:

Target values 0,753 0,021 3,916 0,083

Results 0,793 0,014 3,989 0,057

Deviation mg/dL mg/dL Mean 5,28% 1,86% 3,57%

DiaSys Master calibrator Lot. 8713 DiaSys Creatinin Jaffe reagent, Measurement at Hitachi 911 analyzer with compensation

No further ajustment of master calibrator value 4,294 0,030 mg/dL

TruCal U product calibrator

4,50 0,09

mg/dL

4,50 0,096 2,12%

mg/dL

2008-07-22
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

Creatinin FSC Product Code 2 1739

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Creatinin

Jaffe method with compensation; Concentrated reagent Gas-Chromatography isotope dilution spectrometry 1,18%
1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure
Gas-Chromatography isotope dilution spectrometry, measurement at INSTAND e V

Value Uncertainty

DiaSys Master calibrator Lot. 8713

3,82 0,03 DiaSys Creatinin Jaffe reagent, Measurement at Hitachi 911 analyzer without compensation

mg/dL

SRM 967 Level 1 and Level 2

Evaluating the accuracy of DiaSys Creatinin Jaffe procedure in human serum by validating reference material and human serum samples; Adjustment of DiaSys Master calibrator

SRM 967 Level 1: Level 2:

Target values 0,753 0,021 3,916 0,083

Results 0,972 0,014 3,816 0,057

mg/dL mg/dL Mean

Deviation 29,11% -2,56% 13,27%

Ajusted master calibrator value 4,29 0,03 mg/dL

DiaSys Master calibrator Lot. 8713

Evaluating the accuracy of DiaSys Creatinin Jaffe procedure in human serum by validating reference material; Adjustment of DiaSys Master calibrator

SRM 967 Level 1: Level 2:

Target values 0,753 0,021 3,916 0,083

Results 0,793 0,014 3,989 0,057

mg/dL mg/dL Mean

Deviation 5,28% 1,86% 3,57%

DiaSys Master calibrator Lot. 8713

DiaSys Creatinin Jaffe FSC reagent, Measurement at Olympus AU 600 analyzer with compensation

No further ajustment of master calibrator value 4,29 0,03 mg/dL

SRM 967 Level 1 and Level 2

Evaluating the accuracy of DiaSys Creatinin Jaffe FSC with compensation procedure in human serum by validating reference material; Adjustment of DiaSys Master calibrator

SRM 967 Level 1: Level 2:

Target values 0,753 0,021 3,916 0,083

Results 0,768 0,014 4,070 0,047

mg/dL mg/dL Mean

Deviation 1,99% 3,93% 2,96%

DiaSys Master calibrator Lot. 8713 DiaSys Creatinin Jaffe FSC reagent, Measurement at Olympus AU 640 analyzer with compensation TruCal U product calibrator

No further ajustment of master calibrator value 4,29 0,03 mg/dL

4,25 0,04

mg/dL

4,25 0,05 1,18%

mg/dL

2009-04-17
Date

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

Traceability And Uncertainty:

Gamma-GT FS (Szasz mod. / IFCC mod.) Product Code 1 2801

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Gamma-glutamyltransferase (Gamma-GT)

Kinetic photometric test according to Szasz / Persijn

Original formulation IFCC (Molar extinction coefficient 405 nm), 37 C

1,56%
1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material
Molar extinction coefficient according to original IFCC procedure

Procedure

Value Uncertainty

Original GGT IFCC formulation, Manual measurement at INSTAND e.V. DiaSys Master calibrator 128,0 0,36 Lot. 8713
Evaluating the accuracy of DiaSys GGT IFCC procedure in human serum; Adjustment of DiaSys Master calibrator

U/L

DiaSys Master calibrator Lot. 8713

Uncertainty of value transfer from method comparison original IFCC procedure vs. DiaSys GGT IFCC procedure, based on Passing-Bablock Regression

Ajusted master calibrator value 106,6 3,19 U/L

Passing-Bablock Regression -0,741 y = 1,005 X r = 0,999 Ajusted master calibrator value 106,4 3,18 U/L

U/L

DiaSys Master calibrator Lot. 8713 DiaSys GGT IFCC reagent, Measurement at Hitachi 911 analyzer

TruCal U product calibrator

104 1,59

U/L

104 1,62 1,56%

U/L

2009-04-17
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

Gamma-GT FSC (Szasz mod. / IFCC mod.) Product Code 2 2805

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U

Gamma-glutamyltransferase (Gamma-GT) Kinetic photometric test according to Szasz / Persijn, Concentrated reagent
Original formulation IFCC (Molar extinction coefficient 405 nm), 37 C

0,82%
1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material
Molar extinction coefficient according to original IFCC procedure

Procedure

Value Uncertainty

Original GGT IFCC formulation, Manual measurement at INSTAND e.V. DiaSys Master calibrator 128,0 0,36 Lot. 8713
Evaluating the accuracy of DiaSys GGT IFCC procedure in human serum; Adjustment of DiaSys Master calibrator

U/L

DiaSys Master calibrator Lot. 8713

Uncertainty of value transfer from method comparison original IFCC procedure vs. DiaSys GGT IFCC procedure, based on PassingBablock Regression

Ajusted master calibrator value 106,6 3,19 U/L

Passing-Bablock Regression y = 1,005 X -0,741 r = 0,999 Ajusted master calibrator value 106,4 3,18 U/L

U/L

DiaSys Master calibrator Lot. 8713

Uncertainty of value transfer from method comparison DiaSys GGT IFCC procedure on Hitachi 911 vs. DiaSys GGT IFCC FSC on Olympus AU 600 procedure, based on Passing-Bablock Regression; n=74

Passing-Bablock Regression -2,892 y = 1,038 X r = 1,000 No ajusted of master calibrator value

U/L

DiaSys Master calibrator 106,4 3,18 Lot. 8713 DiaSys GGT IFCC FSC reagent, Measurement at Olympus AU 640 analyzer U/L

TruCal U product calibrator

102 0,78

U/L

102 0,83 0,82%

U/L

2009-04-17
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

GLDH FS DGKC Product Code 1 2411

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Glutamate Dehydrogenase (GLDH) DGKC recommended procedure

Molar extinction coefficient 340 nm = 6,3 L * mmol-1 * cm-1, 37 C 10,80%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material
Molar extinction coefficient according to DGKC recommendation

Procedure

Value Uncertainty

DiaSys GLDH reagent, Manual Measurement

DiaSys Master calibrator 37,25 3,97 Lot. 8713 DiaSys GLDH reagent, Measurement at Hitachi 911 analyzer U/L

TruCal U product calibrator

31,2 0,55

U/L

31,2 3,37 10,80%

U/L

2009-04-17
Date

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber

DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

Traceability & Uncertainty Certificate

Version 1 from 2007

Traceability And Uncertainty:

Glucose GOD FS Product Code 1 2500

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Glucose GOD-PAP method - Trinder reaction

Gas-Chromatography isotope dilution spectrometry 0,95%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure
Gas-Chromatography isotope dilution spectrometry, measurement at INSTAND e.V.

Value Uncertainty

DiaSys Master calibrator 174 0,6 Lot. 8713

DiaSys Glucose GOD 5 min reagent, Measurement at Hitachi 911 analyzer

mg/dL

SRM 965a Level 1 - 4

Level 1: Level 2: Level 3: Level 4:

Evaluating the accuracy of DiaSys Glucose GOD procedure in human serum by validating reference material; Adjustment of DiaSys Master calibrator

Target values 34,56 0,36 78,50 0,86 122,1 1,3 292,6 3,5

Results 35,64 0,27 79,80 0,40 122,7 0,82 292,3 2,27

Deviation mg/dL mg/dL mg/dL mg/dL Mean 3,13% 1,66% 0,50% -0,09% 1,30%

DiaSys Master calibrator Lot. 8713

DiaSys Glucose GOD 10 min reagent, Measurement at Hitachi 911 analyzer

No ajustment of master calibrator value 174 0,6 mg/dL

TruCal U product calibrator

180 1,6

mg/dL

180 1,7 0,95%

mg/dL

2009-04-17
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

Glucose Hexokinase FS Product Code 1 2511

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Glucose Hexokinase method

Gas-Chromatography isotope dilution spectrometry 0,92%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure
Gas-Chromatography isotope dilution spectrometry, measurement at INSTAND e.V.

Value Uncertainty

DiaSys Master calibrator 174 0,6 Lot. 8713 DiaSys Glucose Hexokinase reagent, Measurement at Hitachi 911 analyzer mg/dL

SRM 965a Level 1 - 4

Level 1: Level 2: Level 3: Level 4:

Evaluating the accuracy of DiaSys Glucose Hexokinase procedure in human serum by validating reference material; Adjustment of DiaSys Master calibrator

Target values 34,56 0,36 78,50 0,86 122,1 1,3 292,6 3,5

Results 34,19 0,76 76,44 0,36 118,1 0,80 283,6 2,43

Deviation mg/dL mg/dL mg/dL mg/dL Mean -1,07% -2,63% -3,29% -3,07% -2,51%

DiaSys Master calibrator Lot. 8713 DiaSys Glucose Hexokinase reagent, Measurement at Hitachi 911 analyzer TruCal U product calibrator

No ajustment of master calibrator value 174 0,6 mg/dL

180 1,5

mg/dL

180 1,7 0,92%

mg/dL

2009-04-17
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

Glucose Gluc-DH FS Product Code 1 2539

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Glucose

Glucose Dehydrogenase method (Gluc-DH) Gas-Chromatography isotope dilution spectrometry 0,95%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure
Gas-Chromatography isotope dilution spectrometry, measurement at INSTAND e.V.

Value Uncertainty

DiaSys Master calibrator 174 0,6 Lot. 8713 DiaSys Glucose Gluc-DH reagent, Measurement at Hitachi 911 analyzer mg/dL

SRM 965a Level 1 - 4

Level 1: Level 2: Level 3: Level 4:

Evaluating the accuracy of DiaSys Glucose Gluc-DH procedure in human serum by validating reference material; Adjustment of DiaSys Master calibrator

Target values 34,56 0,36 78,50 0,86 122,1 1,3 292,6 3,5

Results 34,18 0,52 76,97 0,78 118,7 1,34 280,5 2,57

Deviation mg/dL mg/dL mg/dL mg/dL Mean -1,11% -1,95% -2,78% -4,14% -2,49%

DiaSys Master calibrator Lot. 8713 DiaSys Glucose Gluc-DH reagent, Measurement at Hitachi 911 analyzer

No ajustment of master calibrator value 174 0,6 mg/dL

TruCal U product calibrator

180 1,6

mg/dL

180 1,7 0,95%

mg/dL

2009-04-17
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

Glucose Gluc-DH FSC Product Code 2 2539

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Glucose

Glucose Dehydrogenase method (Gluc-DH); Concentrated reagent Gas-Chromatography isotope dilution spectrometry 1,22%
1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure
Gas-Chromatography isotope dilution spectrometry, measurement at INSTAND e V

Value Uncertainty

DiaSys Master calibrator Lot. 8713

174 0,6

mg/dL

DiaSys Glucose Gluc-DH reagent, Measurement at Hitachi 911 analyzer

SRM 965a Level 1 - 4

Level 1: Level 2: Level 3: Level 4:

Evaluating the accuracy of DiaSys Glucose Gluc-DH procedure in human serum by validating reference material; Adjustment of DiaSys Master calibrator

Target values 34,56 0,36 78,50 0,86 122,1 1,3 292,6 3,5

Results 34,18 0,52 76,97 0,78 118,7 1,34 280,5 2,57

mg/dL mg/dL mg/dL mg/dL Mean

Deviation -1,11% -1,95% -2,78% -4,14% -2,49%

DiaSys Master calibrator Lot. 8713 DiaSys Glucose Gluc-DH FSC reagent, Measurement at Hitachi Olympus AU 600 analyzer

No ajustment of master calibrator value 174 0,6 mg/dL

SRM 965a Level 1 - 4

Level 1: Level 2: Level 3: Level 4:

Evaluating the accuracy of DiaSys Glucose Gluc-DH FSC procedure in human serum by validating reference material; Adjustment of DiaSys Master calibrator

Target values 34,56 0,36 78,50 0,86 122,1 1,3 292,6 3,5

Results 35,37 1,87 77,80 1,90 121,4 1,08 286,8 2,31

mg/dL mg/dL mg/dL mg/dL Mean

Deviation 2,34% -0,89% -0,60% -2,00% -0,29%

DiaSys Master calibrator Lot. 8713 DiaSys Glucose Gluc-DH FSC reagent, Measurement at Olympus AU 640 analyzer TruCal U product calibrator

No ajustment of master calibrator value 174 0,6 mg/dL

180 2,1

mg/dL

180 2,2 1,22%

mg/dL

2009-04-17
Date

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

Traceability And Uncertainty:

-HBDH FS Product Code 1 3201

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U

-Hydroxy-butyrate-dehydrogenase -HBDH) ( DGKC recommended procedure Molar extinction coefficient 340 nm = 6,3 L * mmol-1 * cm-1, 37 C 3,98%
1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material
Molar extinction coefficient according to DGKC recommendation

Procedure

Value Uncertainty

DiaSys HBDH reagent, Manual Measurement

DiaSys Master calibrator 196 7,21 Lot. 8713 DiaSys HBDH reagent, Measurement at Hitachi 911 analyzer U/L

TruCal U product calibrator

210 3,20

U/L

210 8,37 3,98%

U/L

2009-04-17
Date

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber

DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

Traceability & Uncertainty Certificate

Version 1 from 2007

Traceability And Uncertainty:

-Hydroxybutyrate FS Product Code 1 3701

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U -Hydroxybutyrate Enzymatic endpoint method Primary reference material 3,03%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure

Value Uncertainty

DL-Hydroxybutyrat, Sigma Cat. No. H-65017 Preparation of an Hydroxybutyrate working solution for use as internal standard Total uncertainty of Standard DiaSys -Hydroxybutyrate Master standard E 02/06 1,00 0,02 mmol/L

DiaSys -Hydroxybutyrate reagent, Measurement at Hitachi 911 analyzer DiaSys Master calibrator 1,04 0,01 Lot. 8713 DiaSys -Hydroxybutyrate reagent, Measurement at Hitachi 911 analyzer mmol/L

TruCal U product calibrator

1,02 0,02

mmol/L

1,02 0,03 3,03%

mmol/L

2009-04-17
Date

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber

DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

Traceability & Uncertainty Certificate

Version 1 from 2007

Traceability And Uncertainty:

Iron FS Ferene Product Code 1 1911

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Iron Ferene SRM 682 - High Purity Zinc 3,74%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material
SRM 682 High Purity Zinc

Procedure

Value Uncertainty

Preparation of an Zinc solution based on SRM 682, used for verification of a Titriplex III (EDTA) solution by complexometric titration

Titriplex III (EDTA)

Complexometric titration Total uncertainty of Tritrisol 1000000 2000 g/dL

Titrisol FeCl3

Production procedure Master Calibrator Iron Standard Lot: QC 12/06 DiaSys Iron reagent, Measurement at Hitachi 911 analyzer DiaSys Master calibrator 179 2,63 Lot. 8713 DiaSys Iron reagent, Measurement at Hitachi 911 analyzer TruCal U product calibrator g/dL

100 0,29

g/dL

203 6,94

g/dL

203 7,6 3,74%

g/dL

2009-04-17
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

Lactate FS Product Code 1 4001

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Lactate LDH UV endpoint method

Primary reference material Molar extinction coefficient 340 nm e = 6,3 L * mmo-1 * cm-1 5,24%
1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure

Value Uncertainty

Molar extinction coefficient Enzymatic Lactate assay according to Bergmeyer, Methods of Enzymatic Analysis, III, 1974, p1464 Uncertainty of Lithium L-lactate Lithium L-lactate; Sigma Cat. No. L-2250 97,00 3,00 mg/dg

Preparation of an lactate working solution for use as internal standard

Internal L-lactate standard

27,6 0,69

mg/dL

DiaSys Lactate reagent, Measurement at Hitachi 911 analyzer DiaSys Master calibrator 25,79 0,82 Lot. 8713 DiaSys Lactate reagent, Measurement at Hitachi 911 analyzer mg/dL

TruCal U product calibrator

28,4 0,35

mg/dL

28,4 1,49 5,24%

mg/dL

2009-04-17
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

LDH FS IFCC Product Code 1 4211

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Lactate Dehydrogenase (LDH) IFCC recommended procedure

Original formulation IFCC (Molar extinction coefficient 340 nm = 6,3 L * mmol-1 * cm-1), 37 C

1,88%
1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material
Molar extinction coefficient according to original IFCC procedure

Procedure

Value Uncertainty

Original LDH IFCC formulation, Manual measurement at INSTAND e.V. DiaSys Master calibrator 218 1,55 Lot. 8713
Evaluating the accuracy of DiaSys LDH IFCC procedure in human serum; Adjustment of DiaSys Master calibrator

U/L

DiaSys Master calibrator Lot. 8713

Uncertainty of value transfer from method comparison original IFCC procedure vs. DiaSys LDH IFCC procedure, based on Passing-Bablock Regression

Ajusted master calibrator value 228 3,48 U/L

Passing-Bablock Regression 8,451 y = 0,949 X + r = 0,990 Ajusted master calibrator value 224 3,44 U/L

U/L

DiaSys Master calibrator Lot. 8713 DiaSys LDH IFCC reagent, Measurement at Hitachi 911 analyzer

TruCal U product calibrator

245 4,27

U/L

245 4,61 1,88%

U/L

2009-04-17
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

LDH FSC IFCC Product Code 2 4269

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Lactate Dehydrogenase (LDH)

IFCC recommended procedure; Concentrated reagent

Original formulation IFCC (Molar extinction coefficient 340 nm = 6,3 L * mmol-1 * cm-1), 37 C

0,91%
1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material
Molar extinction coefficient according to original IFCC procedure

Procedure

Value Uncertainty

Original LDH IFCC formulation, Manual measurement at INSTAND e.V. DiaSys Master calibrator 218 1,55 Lot. 8713
Evaluating the accuracy of DiaSys LDH IFCC procedure in human serum; Adjustment of DiaSys Master calibrator

U/L

DiaSys Master calibrator Lot. 8713

Uncertainty of value transfer from method comparison original IFCC procedure vs. DiaSys LDH IFCC procedure, based on PassingBablock Regression

Ajusted master calibrator value 228 3,48 U/L

Passing-Bablock Regression y = 0,949 X + 8,451 r = 0,990 Ajusted master calibrator value 224 3,44 U/L

U/L

DiaSys Master calibrator Lot. 8713

Uncertainty of value transfer from method comparison DiaSys LDH IFCC procedure on Hitachi 911 vs. DiaSys LDH IFCC FSC on Olympus AU 600 procedure, based on Passing-Bablock Regression; n=74

Passing-Bablock Regression -7,058 y = 1,033 X r = 0,998 No ajusted of master calibrator value

U/L

DiaSys Master calibrator 224 3,44 Lot. 8713 DiaSys LDH IFCC FSC reagent, Measurement at Olympus AU 640 analyzer U/L

TruCal U product calibrator

242 1,37

U/L

242 2,20 0,91%

U/L

2009-04-17
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

LDH FS DGKC Product Code 1 4201

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Lactate Dehydrogenase (LDH) DGKC recommended procedure

Molar extinction coefficient 340 nm = 6,3 L * mmol-1 * cm-1, 37 C 7,44%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material
Molar extinction coefficient according to DGKC recommendation

Procedure

Value Uncertainty

DiaSys LDH DGKC reagent, Manual Measurement

DiaSys Master calibrator 378 27,78 Lot. 8713 DiaSys LDH DGKC reagent, Measurement at Hitachi 911 analyzer U/L

TruCal U product calibrator

411 4,89

U/L

411 30,6 7,44%

U/L

2009-04-17
Date

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber

DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

Traceability & Uncertainty Certificate

Version 1 from 2007

Traceability And Uncertainty:

Lipase DC FS Product Code 1 4321

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Lipase Direct colorimetric method

Roche formulation (Molar extinction coefficient) 2,93%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material
Molar extinction coefficient according to Roche procedure

Procedure

Value Uncertainty

Roche formulation, Manual measurement

Roche C.f.a.s calibrator 72,2 1,42 Lot. 174674 Roche Lipase reagent, Measurement at Hitachi 911 analyzer DiaSys Master calibrator 107 1,31 Lot. 8713
Uncertainty of value transfer from method comparison Roche Hitachi procedure vs. DiaSys Hitachi procedure, based on Passing-Bablock Regression

U/L

U/L

Passing-Bablock Regression y = 1,074 X + 0,567 r = 0,999 Ajusted master calibrator value 100 0,73 U/L

U/L

DiaSys Master calibrator Lot. 8713 DiaSys Lipase reagent, Measurement at Hitachi 911 analyzer

TruCal U product calibrator

91,4 1,64

U/L

91,4 2,68 2,93%

U/L

2009-04-17
Date

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber

DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

Traceability & Uncertainty Certificate

Version 1 from 2007

Traceability And Uncertainty:

Magnesium XL FS Product Code 1 4610

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Magnesium Xylidyl blue method Atomic absorption Spectrometry 3,67%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure
Atomic absorption Spectrometry, measurement at INSTAND e.V.

Value Uncertainty

DiaSys Master calibrator 3,96 0,05 Lot. 8713 DiaSys Magnesium XL reagent, Measurement at Hitachi 911 analyzer mg/dL

SRM 956b Level 1, Level 2 and Level 3

Level 1: Level 2: Level 3:

Evaluating the accuracy of DiaSys Magesium XL procedure in human serum by validating reference material; Adjustment of DiaSys Master calibrator

Target values 3,699 0,048 2,417 0,031 1,113 0,014

Results 3,623 0,087 2,452 0,053 1,197 0,056

Deviation mg/dL mg/dL mg/dL Median -2,06% 1,44% 7,56% 1,44%

DiaSys Master calibrator Lot. 8713 DiaSys Magnesium XL reagent, Measurement at Hitachi 911 analyzer

No ajustment of master calibrator value 3,96 0,05 mg/dL

TruCal U product calibrator

3,78 0,13

mg/dL

3,78 0,14 3,67%

mg/dL

2009-04-17
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

Phosphate FS Product Code 1 5211

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Inorganic Phosphate Molybdate method SRM 723d 3,03%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material
SRM 723d; Tris for use in acidimetric standardization

Procedure

Value Uncertainty

Alcalimetric titration at Merck KGaA Darmstadt / Germany Merck Phosphate Standard 1.19898.0500; Lot HC606248 Preparation of an Phosphate working solution for use as internal standard Internal standard; Phosphate working solution DiaSys Phosphate reagent, Measurement at Hitachi 911 analyzer DiaSys Master calibrator 5,17 0,12 Lot. 8713 DiaSys Phosphate reagent, Measurement at Hitachi 911 analyzer mg/dL Total uncertainty of Standard incl. SRM 723d 32,68 0,07 mg/dL

6,53 0,01

mg/dL

TruCal U product calibrator

5,44 0,11

mg/dL

5,44 0,16 3,03%

mg/dL

2009-04-17
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

Triglycerides FS Product Code 1 5710

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Triglycerides GPO method - Trinder reaction

Gas-Chromatography isotope dilution spectrometry (GC ID-MS) 1,60%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure
Gas-Chromatography isotope dilution spectrometry, measurement at INSTAND e.V.

Value Uncertainty

DiaSys Master calibrator 136 0,9 Lot. 8713 DiaSys Triglycerides 5 min reagent, Measurement at Hitachi 911 analyzer mg/dL

76,1

SRM 1951b Level 1 and Level 2

Level 1: Level 2:

Target values 107,0 1,2 239,1 2,4

Results 108,9 1,1 235,7 0,2

Deviation mg/dL mg/dL Mean 1,78% -1,42% 0,18%

Evaluating the accuracy of DiaSys Triglycerides procedure in human serum by validating reference material; Adjustment of DiaSys Master calibrator

DiaSys Master calibrator Lot. 8713 DiaSys Triglycerides 10 min reagent, Measurement at Hitachi 911 analyzer

No ajustment of master calibrator value 136 0,9 mg/dL

TruCal U product calibrator

144 2,1

mg/dL

144 2,3 1,60%

mg/dL

2009-04-17
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

Triglycerides FSC Product Code 2 5720

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Triglycerides

GPO method - Trinder reaction; Concentrated reagent Gas-Chromatography isotope dilution spectrometry (GC ID-MS) 1,19%
1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure
Gas-Chromatography isotope dilution spectrometry, measurement at INSTAND e.V.

Value Uncertainty

DiaSys Master calibrator 136 0,9 Lot. 8713 DiaSys Triglycerides 5 min reagent, Measurement at Hitachi 911 analyzer mg/dL

76,1

SRM 1951b Level 1 and Level 2

Level 1: Level 2:

Target values 107,0 1,2 239,1 2,4

Results 108,9 1,1 235,7 0,2

Deviation mg/dL mg/dL Mean 1,78% -1,42% 0,18%

Evaluating the accuracy of DiaSys Triglycerides procedure in human serum by validating reference material; Adjustment of DiaSys Master calibrator

DiaSys Master calibrator Lot. 8713 DiaSys Triglycerides FSC reagent, Measurement at Olympus AU 600 analyzer

No ajustment of master calibrator value 136 0,9 mg/dL

SRM 1951b Level 1 and Level 2

Level 1: Level 2:

Target values 107,0 1,2 239,1 2,4

Results 113,9 1,0 246,4 1,4

Deviation mg/dL mg/dL Mean 6,45% 3,05% 4,75%

Evaluating the accuracy of DiaSys Triglycerides FSC on Olympus AU 600 procedure in human serum by validating reference material; Adjustment of DiaSys Master calibrator

DiaSys Master calibrator Lot. 8713 DiaSys Triglycerides FSC reagent, Measurement at Olympus AU 640 analyzer

No ajustment of master calibrator value 136 0,9 mg/dL

TruCal U product calibrator

143 1,4

mg/dL

143 1,7 1,19%

mg/dL

2009-04-17
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

Total protein FS Product Code 1 2311

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Total protein Biuret method with sample blank Modified Biuret method 1,00%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure
Modified Biuret method, measurement at INSTAND e.V.

Value Uncertainty

DiaSys Master calibrator 71,1 0,39 Lot. 8713 DiaSys Total Protein FS reagent, Measurement with sample blank at Hitachi 911 analyzer TruCal U product calibrator g/L

76,1 0,64

g/L

76,1 0,76 1,00%

g/L

2009-04-17
Date

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber

DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

Traceability & Uncertainty Certificate

Version 1 from 2007

Traceability And Uncertainty:

Total protein FSC Product Code 2 2329

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Total protein

Biuret method with sample blank; Concentrated reagent Modified Biuret method 0,96%
1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure
Modified Biuret method, measurement at INSTAND e.V.

Value Uncertainty

DiaSys Master calibrator 71,1 0,39 Lot. 8713

Evaluating the accuracy of DiaSys Total Protein FSC procedure on Olympus AU 600 analyzer by validating control samples; No adjustment of DiaSys Master calibrator

g/L

DiaSys Master calibrator 76,1 0,39 Lot. 8713 DiaSys Total Protein FSC reagent, Measurement with sample blank at Olympus AU 640 analyzer TruCal U product calibrator g/L

75,0 0,59

g/L

75,0 0,72 0,96%

g/L

2009-04-17
Date

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber

DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

Traceability & Uncertainty Certificate

Version 1 from 2007

Traceability And Uncertainty:

Urea FS Product Code 1 3101

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Urea Urease-GLDH kinetic method SRM 909b Level 1 4,33%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland

2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure

Value Uncertainty

SRM 909b Level 1

33,11 0,91

mg/dL

DiaSys Urea kinetic reagent, Measurement at Hitachi 911 analyzer DiaSys Master calibrator 94,06 2,72 Lot. 8713
Evaluating the accuracy of DiaSys Urea kinetic procedure by validating reference material SRM 909b Level 1 and Level 2; Adjustment of DiaSys Master calibrator

mg/dL

Target values 76,1 33,11 0,91 Level 2: 184,7 2,0

Results 32,2 1,20 187 4,31

Deviation mg/dL mg/dL Mean -2,75% 1,25% -0,75%

DiaSys Master calibrator Lot. 8713 DiaSys Urea kinetic reagent, Measurement at Hitachi 911 analyzer

Ajusted master calibrator value 94,8 2,74 mg/dL

TruCal U product calibrator

98,1 1,65

mg/dL

98,1 4,25 4,33%

mg/dL

2009-04-17
Date

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber

DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

Traceability & Uncertainty Certificate

Version 1 from 2007

Traceability And Uncertainty:

Urea FSC Product Code 2 3105

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Urea Urease-GLDH kinetic method; Concentrated reagent SRM 909b Level 1 4,12%
1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure

Value Uncertainty

SRM 909b Level 1

33,11 0,91

mg/dL

DiaSys Urea kinetic reagent, Measurement at Hitachi 911 analyzer DiaSys Master calibrator 94,06 2,72 Lot. 8713 Target values 33,11 0,91 184,7 2,0 Results 32,2 1,20 187 4,31 Deviation mg/dL mg/dL Mean Ajusted master calibrator value 94,06 2,72 Lot. 8713
Evaluating the accuracy of DiaSys Urea FSC kinetic procedure on Olympus AU 600 analyzer by validating reference material SRM 909b Level 1 and Level 2; No adjustment of DiaSys Master calibrator

mg/dL

Evaluating the accuracy of DiaSys Urea kinetic procedure by validating reference material SRM 909b Level 1 and Level 2; No adjustment of DiaSys Master calibrator

76,1 Level 2:

-2,75% 1,25% -0,75%

DiaSys Master calibrator

mg/dL

Level 1: Level 2:

Target values 33,11 0,91 184,7 2,0

Results 32,9 0,74 181 2,18

Deviation 0 0 Mean -0,63% -2,00% -1,32%

DiaSys Master calibrator Lot. 8713 DiaSys Urea kinetic FSCreagent, Measurement at OlympusAU 640 analyzer

No ajustment of master calibrator value 94,06 2,72 mg/dL

TruCal U product calibrator

95,8 0,97

mg/dL

95,8 3,94 4,12%

mg/dL

2009-04-17
Date DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

This certificate of traceability & uncertainty is a computer printout and has therefore no been signed by hand. Sign.: Benno Weber Traceability & Uncertainty Certificate Version 1 from 2007

Traceability And Uncertainty:

Urea CT FS Product Code 1 3115

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Urea Colorimetric endpoint method (Berthelot) SRM 909b Level 1 4,88%
1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland

2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure

Value Uncertainty

SRM 909b Level 1

33,11 0,91

mg/dL

DiaSys Urea Berthelot reagent, Measurement at Hitachi 911 analyzer DiaSys Master calibrator 93,69 1,93 Lot. 8713
Evaluating the accuracy of DiaSys Urea Berthelot procedure by validating reference material SRM 909b Level 1 and Level 2; Adjustment of DiaSys Master calibrator

mg/dL

Target values 76,1 33,11 0,91 Level 2: 184,7 2,0

Results 33,13 1,35 182,6 2,5

Deviation mg/dL mg/dL Mean 0,07% -1,14% -0,53%

DiaSys Master calibrator Lot. 8713 DiaSys Urea Berthelot reagent, Measurement at Hitachi 911 analyzer

Ajusted master calibrator value 94,19 1,94 mg/dL

TruCal U product calibrator

95,6 3,32

mg/dL

95,6 4,67 4,88%

mg/dL

2009-04-17
Date

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber

DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

Traceability & Uncertainty Certificate

Version 1 from 2007

Traceability And Uncertainty:

Uric Acid FS TBHBA Product Code 1 3021

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Uric acid Uricase-TBHBA method

Gas-Chromatography isotope dilution Spectrometry 0,89%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure

Value Uncertainty

GC ID-MS, measurement at INSTAND e.V.

DiaSys Master calibrator 5,21 0,026 Lot. 8713 DiaSys Uric acid TBHBA reagent, Measurement at Hitachi 911 analyzer mg/dL

TruCal U product calibrator

5,39 0,04

mg/dL

5,39 0,05 0,89%

mg/dL

2009-04-17
Date

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber

DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

Traceability & Uncertainty Certificate

Version 1 from 2007

Traceability And Uncertainty:

Uric Acid FS TOOS Product Code 1 3001

Product Code 5 9100

Calibrator: Analyte: Method: Reference: Total Uncertainty: Literature:

TruCal U Uric acid Uricase-TOOS method

Gas-Chromatography isotope dilution Spectrometry 1,06%

1. ISO GUM (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva, Switzerland 2. EURACHEM Guide (1995) Quantifying uncertainty in analytical measurement. EURACHEM, Teddington, UK

Material

Procedure

Value Uncertainty

GC ID-MS, measurement at INSTAND e.V.

DiaSys Master calibrator 5,21 0,026 Lot. 8713 DiaSys Uric acid TOOS reagent, Measurement at Hitachi 911 analyzer mg/dL

TruCal U product calibrator

5,34 0,05

mg/dL

5,34 0,06 1,06%

mg/dL

2009-04-17
Date

This certificate of traceability & uncertainty is a computer printout and has therefore not been signed by hand. Sign.: Benno Weber

DiaSys Diagnostic Systems GmbH 65558 Holzheim (Germany)

Traceability & Uncertainty Certificate

Version 1 from 2007