• Working Party• Meeting 2013 and 2014• Australasian Involvement• Publications in Pipeline• Paediatric WP• Pregnant Ranges Evaluated• Recommendations for action

• Results to Date• Tests added to List• Action by Laboratories• Battachyria analysis• Data extraction analysis• Median of Values obtained• Calculated Ranges

• Survey results• Bias Assessment• Battacharyia• Aussie Normals• Manufacturers RI• Calculated Results Survey• Back to basics check

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

4.8 4.9 5.0 5.1 5.2 5.3 5.4 5.5 5.6 5.7

Upper reference interval for Potassium mmol/L

4.8

4.9

5.0

5.1

5.2

5.3

5.4

5.5

5.6

5.7

3.8

3.9

4

4.1

4.2

4.3

4.4

4.5

4.6

4.7

4.8

4.9

5

5.1

5.2

5.3

5.4

3.8 3.9 4 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 5 5.1 5.2 5.3 5.4

ADVIA 2400 Architect AU2700 DxCIntegra Modular RxL VitrosLinear (ADVIA 2400) Linear (Architect) Linear (AU2700) Linear (DxC)Linear (Integra) Linear (Modular ) Linear (RxL) Linear (Vitros)

Potassium Variation

• Instrument Variation

• Pre Analytical Variables

• ISE Technology

• Precision of Assay

ISE Nernst Equation

• Use of common equation

• Differences due to electrode factors

• Variations minimal

• CV 1-2% obtained

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

70.0%

95 100 105 110 115 120 125

Upper reference interval for Creatinine umol/L Male

95

100

105

110

115

120

125

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104112120128136144152

40 48 56 64 72 80 88 96 104 112 120 128 136 144 152

Alan

lytic

al p

altfo

rm a

vera

ge c

once

ntra

tion

Average

Creatinine

ADVIA 2400 Architect AU2700 DxCIntegra Modular RxL VitrosLinear (ADVIA 2400) Linear (AU2700) Linear (DxC) Linear (Integra)Linear (Modular ) Linear (RxL) Linear (Vitros)

Creatinine Standardisation

• Equation for eGFR – CKD - EPI• Standardisation of all methods• Various intercepts in place – method

dependent or are they?• Review of manufacturers calculation

parameters

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

40.0%

40 45 50 55 60 65

Upper reference interval for GGT

40

45

50

55

60

65

• Manufacturer Decision• Allowable Limits of Performance – Calibrator• Allowable limits for Performance – Extinction

Coefficients• Commonality of Calculation Factors• Method Variations

Enzyme Calculation

• Manufacturer Dependent

• Calibration from Extinction Coefficient

• Calibration from Prepared Calibrator

• Dry Chemistry Estimation

0

5

10

15

20

25

30

35

40

45

50

55

0 5 10 15 20 25 30 35 40 45 50 55

ADVIA 2400 Architect AU2700 DxCIntegra Modular RxL VitrosLinear (ADVIA 2400) Linear (Architect) Linear (AU2700) Linear (DxC)Linear (Integra) Linear (Modular ) Linear (RxL) Linear (Vitros)

Enzyme Kinetics

• 1St Order Reaction• Zero Order Reaction• Initial Velocity Reaction• Km Values• Inhibitors – Competitive, Non Competitive and

Uncompetitive

Colorimetric Reactions

• Optimisation of Chemistries• Wavelength Selection• Reaction reading times• Calibrator values• Calculation from data obtained

Reaction Traces

• End point reactions

• Rate Reactions

• Similarity between Manufacturers

• Choice of slope parameters

• Abbott Diagnostics Architect• Roche Diagnostics Modular• Roche Diagnostics Integra• Beckman Coulter DxC• Beckman Coulter Olympus• Siemens Healthcare Dimension• Siemens Healthcare Advia• Ortho Clinical Diagnostics Vitros.

0.0

5.0

10.0

15.0

20.0

25.0

30.0

0 5 10 15 20 25 30

Iron

Obt

aine

d

Iron Average

Iron

ADVIA2400Architect

AU2700

DxC

5.0

10.0

15.0

20.0

25.0

30.0

5 10 15 20 25 30

Iron

Obt

aine

d

Iron Average

Iron

ADVIA 2400ArchitectAU2700DxCModularVitros

• Decision ? Implement LDH L-P, ALT, Urate.

• Platform Suitability

• Manufacturer Involvement – LDH (L-P)

• Involve Manufacturers

• Obtain Calculated Values for Comparison

• Comparisons with Population results

• Implement Standardised Calculation values

• Gus Koerbin• Ken Sikaris• Graeme Jones• Maxine Reed• George Koumentakis• Jill Tate• Jan Gill• All who have participated in the 2013 Symposium• All involved with the Harmonisation Initiative