common reference intervals addition or takeover
Post on 30-Jan-2022
3 Views
Preview:
TRANSCRIPT
• 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
4048566472808896
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
top related