Reporting HbA1c - IFCC 11 19 HbA1c Weykamp.pdf · Reporting HbA1c Task Force for HbA1c ... and also...
Transcript of Reporting HbA1c - IFCC 11 19 HbA1c Weykamp.pdf · Reporting HbA1c Task Force for HbA1c ... and also...
Reporting HbA1c Task Force for HbA1c
Cas Weykamp, Secretary
IFCC General Conference, Kuala Lumpur, Malaysia, 19 November 2012
Development Reference Method
IFCC
IFCC Scientific Division
Working Group HbA1c Chair: Garry John
Network HbA1c Coordinator: Cas Weykamp
2009: Evaluation
Analytical The IFCC Reference Measurement Procedure for HbA1c
is accepted worldwide as the only valid anchor for the
standardisation of HbA1c and should be maintained
in a Network of reference laboratories
Reporting Units and Use HbA1c Reporting of HbA1c in SI units (mmol/mol) and use
of HbA1c for diagnosis and screening is discussed
worldwide and Education should be intensified
Disband Working Group….
IFCC
IFCC Scientific Division
Working Group HbA1c Chair: Garry John
Network HbA1c Coordinator: Cas Weykamp
….Reorganise
IFCC
IFCC Scientific Division
IFCC C-TLM
Network HbA1c Coordinator: Cas Weykamp
Integrated Project HbA1c Chair: Garry John
Metrological Aspects Educational/Clinical Aspects
Definition The Task Force for HbA1c is an Integrated Project that
involves input from a number of IFCC functional units
and also from clinical experts in the field of Diabetes
Task Force HbA1c
Definition The Task Force for HbA1c is an Integrated Project that
involves input from a number of IFCC functional units
and also from clinical experts in the field of Diabetes
Aim To establish an interface between IFCC and its National
/Corporate members and the clinical users of HbA1c to
enable the implementation of a scientifically sound reporting
structure for HbA1c standardised to the
IFCC Reference Measurement Procedure
Task Force HbA1c
Group Experts
Analytical * Advisory Board Network Reference Labs
* Scientific Links between National networks
* Work with Manufacturers
Units and Education * Links Professional Bodies Transition Units
* Help Implementation Consensus Statement
* Monitor introduction Consensus Statement
Quality Targets monitoring, diagnosis, screening
Objectives Task Force HbA1c
Group Experts Prof. G. John Chair UK
Dr. C. Weykamp Secretary NL
Prof. L. Ji Member CN
Prof. I Takei Member JP
Dr. D. Sacks Member US
Dr. R. Little Member US
Dr. E. Lenters Member NL
Prof. P. Gillery SD Liaison FR
Dr. R. Hinzmann EMD Liaison DE
Dr. G. Sypniewska CPD Liaison PL
Objectives Task Force HbA1c
Group Experts
Analytical * Advisory Board Network Reference Labs
* Scientific Links between National networks
* Work with Manufacturers
Units and Education * Links Professional Bodies Tranisition Units
* Help Implementation Consensus Statement
* Monitor introduction Consensus Statement
Quality Targets monitoring, diagnosis, screening
Objectives Task Force HbA1c
US
US JP JP
JP
NL NL
I
D F
D US
CH KO
IN
Approved Approved 2012 Candidate
IFCC Network Labs
?
Tasks Network
Warrant Availability
Tools
Continuity Traceability
Warrant Network
Quality HbA1c worldwide IFCC
Traceable
SOP
Calibrator Sets
Rules
Statistics
Approval Candidates
Re-Approval Network Labs
Manufacturers
EQA/PT Organisers
DCM’s
Control Sets
Organisation Others
Candidate Shanghai Approved
Approval Lab Elliptic (Study Cape Town)
-4
-3
-2
-1
0
1
2
3
4
-0,06 -0,04 -0,02 0 0,02 0,04 0,06
Proportional Bias
Syste
mati
c B
ias
lab_01
lab_02
lab_03
lab_05
lab_06
lab_08
lab_11
lab_12
lab_14
lab_15
lab_16
lab_17
lab_18
Periodical Re-Approval Network Labs
Clin Chem
2008;54:240-8
The IFCC Reference Measurement System for HbA1c:
A 6-Year Progress Report
Cas Weykamp (1*), W. Garry John (2), Andrea Mosca (3)
Tadao Hoshino (4), Randie Little (5), Jan-Olof Jeppsson (6)
Kor Miedema (8), Gary Myers (9), Hans Reinauer (10)
David Sacks (11), Robbert Slingerland (8), Carla Siebelder (1)
Link National Networks:Master Equations
IFCC
NGSP
Japan Scandin.
We can tranfer
All old
Clinical
Studies To the new
IFCC
Reference
Method
-0,70
-0,60
-0,50
-0,40
-0,30
-0,20
-0,10
0,00
0,10
0,20
0,30
½ 1 1½ 2 2½ 3 3½ 4 4½ 5 5½ 6 6½ 7 7½ 8 9 10
% N
GS
P
NGSP
Scientific Link Network US Master Equation IFCC – NGSP over 10 years
Green = Low HbA1c Level Blue = High HbA1c level
Scientific Link Network Japan Master Equation IFCC – JDS/JSCC over 10 years
Green = Low HbA1c Level Blue = High HbA1c level
Work with Manufacturers
Group Experts
Analytical * Advisory Board Network Reference Labs
* Scientific Links between National networks
* Work with Manufacturers
Units and Education * Links Professional Bodies Transition Units
* Help Implementation Consensus Statement
* Monitor introduction Consensus Statement
Quality Targets monitoring, diagnosis, screening
Objectives Task Force HbA1c
1. HbA1c Standardised Worldwide
2. IFCC is the Anchor
3. HbA1c reported IFCC and NGSP
5. IFCC, NGSP in Guidelines
6. Implementation Soon
Essention Consensus Statement IDF – ADA – EASD - IFCC
Links: Meetings
• Update Consensus Statement,Dubai (GJ)
• Workshop Brazilian Society, Salvador (GJ + CW)
• IDF-WPR Congress and AASD Kyoto (GJ)
• Manufacturer Forum AACC Los Angeles (GJ + CW)
• WHO: hbA1c in developing countries
Links: Survey
Mean Labs 10
Reference Method 7
Manufacturer 2
Example Transition
Campaign Netherlands -Collaboration Professionals
-Publication Campaign
(support Ministry Health)
Group Experts
Analytical * Advisory Board Network Reference Labs
* Scientific Links between National networks
* Work with Manufacturers
Units and Education * Links Professional Bodies Transition Units
* Help Implementation Consensus Statement
* Monitor introduction Consensus Statement
Quality Targets monitoring, diagnosis, screening
Objectives Task Force HbA1c
Use of HbA1c
1. Monitoring Therapy Diabetes Type I
(DCCT Study)
2. Monitoring Therapy Diabetes Type II
(UKPDS Study)
3. Diagnosis and Screening?
Norms Diagnosis Diabetes
Year Authority
1979 NDDG (USA) and WHO
1997 ECDC (USA) and WHO
2009 IEC (ADA – EASD – IDF)
1979 WHO 1997 WHO 2009 IEC
Gold Glucose Fasting
Standard Tolerance Plasma HbA1c
Test Glucose
Concept Glucose Long Term Long Term
Concentration Complications Complicatis
Norms FPG >140 FPG >125 HbA1c
2HPG >200 2HPG >200 >6.4%
FPG <140 FPG 110-125 HbA1c
2HPG 140-200 5.8 – 6.4%
Terminology Impaired Impaired Increasing
“Doubt” Glucose Fasting Risk
Tolerance Glucose
2009 IEC
Guided by the successfull
Standardisation of HbA1c
the Committee investigated
HbA1c as tool for diagnosis
and concluded:
“HbA1c is the Gold Standard
For Diagnosis and Screening”
2009: IEC (ADA – EASD –IDF) Leading Concept Long Term Complications
Gold Standard HbA1c
Parameter HbA1c HbA1c
mmol/mol %
Diabetes >46 >6.4
Increasing Risk 40 – 46 5.8 – 6.4
Normal <40 <5.8
IEC = International Expert Committee IDF = International Diabetes Federation
ADA = American Diabetes Organisation HbA1c = Hemoglobin A1c
EASD = European Association Study diabetes
HbA1c
>46 mmol
HbA1c
<40 mmol
46 mmol
HbA1c
40 mmol
Diabetes
Increased Risk
Developing
Diabetes
Low Risk
Experts: Diagnosis and Screening
Diagnosis
Screening
This is the Picture
But is the Quality of HbA1c
good enough
for Diagnosis and Screening?
Norms?
Calibration
Reproducibility
Erythrocyte
Lifespan
Global Standardisation
IFCC Working Group
Good Calibrators
Manufacturers
EQA Organisers
Accuracy Based
Individual laboratories
Attend Calibration
Calibration Improved
Calibration
Reproducibility
Erythrocyte
Lifespan
Better instruments
Manuafacturers
Attention
EQA Organisers
Attention
Individual Labs
Reproducibility Improved
Calibration
Reproducibility
Erythrocyte
Lifespan
Calibration Reproducibility
Erythrocyte
Lifespan
1998 2012
Contribution Uncertainty Interpretation HbA1c
Calibration Reproducibility
Erythrocyte
Lifespan
If
High Quality HbA1c Assay
Is used…….
……Erythrocyte
Lifespan
Major source
Uncertainty in
Interpretation
Erythrocyte Lifespan
If Erythrocyte Lifespan (EL) is 10% shorter….
…. HbA1c will be 10% lower
Example
Two persons, same glycaemic status
A: Normal EL: HbA1c = 6.5%
B: 10% Shorter EL: HbA1c = 5.9%
Interpretation of HbA1c of Person B
Will lead to wrong interpretation of
Glycaemic status
Calibration Reproducibility
Erythrocyte
Lifespan
Biological Variation
- Inter Individual?
- Intra individual?
- Ill Non diabetics
-Ethnic Groups
Not many Data
“Not too big a problem”
Large Study required
Future Plans Task Force
Symposium IFCC WorldLab Istanbul June 2014
* Quality specifications Monitoring/Diagnosis
* Status Implementation Consensus Statement
* View HbA1c for Diagnosis/Screening
Meetings
* IDF Sydney (revision Consensus Statement)
* IP meeting EuroMedLab Milan
Various
* Review Paper
* Survey 2 collaboration WHO
Discussion
Reporting HbA1c……..
………..IFCC and NGSP units?
HbA1c for Diagnosis……
……fit for purpose?
Emerging use HbA1c…..
…. In non-diabetic (cardiovascular)?
Your View