HbA1c - standardiseringsläget - Equalis-resultat Equalis användarmöte 2013-04-10 1 Gunnar Nordin, Equalis
HbA1c background The Equalis scheme 10 distributions fresh pooled samples, 30 70 mmol/mol Shift of reference method until 2010: Results in Mono S% units and traceble to the Mono S procedure from 2011: Results in IFCC units mmol/mol and traceble to the IFCC reference method Target values for the EQA material Mono S target values, mean values from selected Mono S labs IFCC target values, mean values from IFCC secondary reference methods 2
Deviation from target (Mono S) %-unit Mean yearly deviation of EQA results for Region A mostly Mono S HbA1c mean yearly deviation from target - Hospital labs 0,4 0,3 0,2 0,1 0-0,1-0,2-0,3 Deviation from Mono S target -0,4 2007 2008 2009 2010 2011 2012 Region A Mono S 3
Deviation from target (Mono S) %-unit Deviation from target (IFCC) mmol/mol Mean yearly deviation of EQA results for Region A mostly Mono S 0,4 0,3 HbA1c mean yearly deviation from target - Hospital labs ΔHbA1c (IFCC)=ΔHbA1c(Mono S)x10,45 4 3 0,2 0,1 0-0,1 2 1 0-1 -0,2-0,3 Deviation from IFCC target -0,4-4 2007 2008 2009 2010 2011 2012-2 -3 Region A Mono S Region A Mono S 4
IFCC monitoring program continous check of the original Mono S-level 5
Deviation from target (Mono S) %-unit Deviation from target (IFCC) mmol/mol Mean yearly deviation of EQA results for Region B mostly Bio Rad 0,4 0,3 HbA1c mean yearly deviation from target - Hospital labs Introduction of Variant Turbo 2.0 4 3 0,2 0,1 0-0,1-0,2-0,3 2 1 0-1 -2-3 -0,4-4 2007 2008 2009 2010 2011 2012 Region B BioRad Region A Mono S Region A Mono S 6
Deviation from target (Mono S) %-unit Deviation from target (IFCC) mmol/mol Mean yearly deviation of EQA results for Region B mostly Bio Rad 0,4 0,3 HbA1c mean yearly deviation from target - Hospital labs 4 3 0,2 0,1 0-0,1-0,2-0,3 2 1 0-1 -2-3 -0,4-4 2007 2008 2009 2010 2011 2012 Region B BioRad Region A Mono S Region B BioRad Region A Mono S 7
Deviation from target (Mono S) %-unit Deviation from target (IFCC) mmol/mol Mean yearly deviation of EQA results for Region C Variant II and Tosoh G7/G8 0,4 0,3 HbA1c mean yearly deviation from target - Hospital labs 4 3 0,2 0,1 0-0,1-0,2-0,3 Variant II 2 1 0-1 -2-3 -0,4-4 2007 2008 2009 2010 2011 2012 Region B BioRad Region A Mono S Region C Tosoh Region B BioRad Region A Mono S 8
Deviation from target (Mono S) %-unit Deviation from target (IFCC) mmol/mol Mean yearly deviation of EQA results for Region C Variant II and Tosoh G7/G8 0,4 0,3 HbA1c mean yearly deviation from target - Hospital labs 4 3 0,2 2 0,1 1 0 0-0,1-1 -0,2-0,3 Variant II Tosoh G8-2 -3-0,4-4 2007 2008 2009 2010 2011 2012 Stockholm Mono S Västra Götaland Mono S Värmland Mono S Stockholm IFCC Västra Götaland IFCC Värmland IFCC 9
HbA1c sample 2 (mmol/mol) The Swedish Danish survey 2012 86 84 82 80 78 Method D-10 MonoS Tosoh G7/G8 Tosoh G7/G8 (BioRad kal) Tosoh G7/G8 (ERL) 76 Tosoh G7/G8 (Mono S kal) 74 72 Variant II Turbo Variant II Turbo (ERL) 70 45 47 49 51 53 55 HbA1c sample 1 (mmol/mol) 10
HbA1c sample 2 (mmol/mol) The Swedish Danish survey 2012 86 84 82 80 78 76 74 72 Method D-10 MonoS Tosoh G7/G8 Tosoh G7/G8 (BioRad kal) Tosoh G7/G8 (ERL) Tosoh G7/G8 (Mono S kal) Variant II Turbo Variant II Turbo (ERL) MCA/ERL 70 45 47 49 51 53 55 HbA1c sample 1 (mmol/mol) 11
HbA1c sample 2 (mmol/mol) The Swedish Danish survey 2012 86 84 82 80 78 76 74 72 Method D-10 MonoS Tosoh G7/G8 Tosoh G7/G8 (BioRad kal) Tosoh G7/G8 (ERL) Tosoh G7/G8 (Mono S kal) Variant II Turbo Variant II Turbo (ERL) MCA/ERL NGSP 70 45 47 49 51 53 55 HbA1c sample 1 (mmol/mol) 12
HbA1c sample 2 (mmol/mol) 86 84 82 80 78 76 74 72 Method D-10 MonoS Tosoh G7/G8 Tosoh G7/G8 (BioRad kal) Tosoh G7/G8 (ERL) Tosoh G7/G8 (Mono S kal) Variant II Turbo Variant II Turbo (ERL) MCA/ERL NGSP RM 70 45 47 49 51 53 55 HbA1c sample 1 (mmol/mol) 13
HbA1c sample 2 (mmol/mol) The Swedish Danish survey 2012 86 84 82 80 78 76 74 72 Method D-10 MonoS Tosoh G7/G8 Tosoh G7/G8 (BioRad kal) Tosoh G7/G8 (ERL) Tosoh G7/G8 (Mono S kal) Variant II Turbo Variant II Turbo (ERL) MCA/ERL NGSP RM 70 45 47 49 51 53 55 HbA1c sample 1 (mmol/mol) 14
Resultat från hösten 2012 För höga HbA1cresultat med flera sjukhussystem kvalitetsmål Resultat inom målen för de två patientnära systemen 15
The traceability chain (ISO 17511) The temporary solution?? 16
A temporary solution a fresh frozen whole blood with target values from IFCC ( primary ) reference method 17
Afinion - HbA1c D-10 Hemoglobin A1c DCA 2000 - HbA1c DCA Vantage HPLC-Mono S Tina-quant Tosoh/BioRad kal Tosoh/MCA kal Tosoh/Mono S kal Tosoh/Tosoh kal Variant Turbo/BioRad kal Variant Turbo/MCA kal Others HbA1c (mmol/mol) HbA1c EQA January 2013, results per method group 65 63 61 59 57 55 53 51 49 47 45 2SD 2013-w03 Report group 18
Afinion - HbA1c D-10 Hemoglobin A1c DCA 2000 - HbA1c DCA Vantage HPLC-Mono S Tina-quant Tosoh/BioRad kal Tosoh/MCA kal Tosoh/Mono S kal Tosoh/Tosoh kal Variant Turbo/BioRad kal Variant Turbo/MCA kal Others HbA1c (mmol/mol) Från och med årsskiftet ny kalibreringsrutin möjlig: MCA kal resultat 2013 vecka 03 65 63 61 59 57 55 53 51 49 47 45 Lab som infört den nya rutinen presterar bra 2SD 2013-w03 Report group 19
HbA1c (mmol/mol) Från och med årsskiftet ny kalibreringsrutin möjlig: MCA kal resultat 2013 vecka 08 Observandum: just nu många låga resultat med Afinion HbA1c 55 53 51 49 47 45 43 41 39 37 35 2SD 2013-08 Rapportgrupp 20
HbA1c (mmol/mol) Resulat 2013-12 Observandum: just nu många låga resultat med Afinion HbA1c 90 85 80 75 70 65 60 2 SD 2013w12 Method group
Ett annat sätt presentera resultaten på metodgrupp andel resultat inom kvalitetsmålet Afinion - HbA1c 39 D-10 100 DCA 2000 HbA1c 86 DCA Vantage 81 HPLC Mono S 100 Tina-quant 100 Tosoh/MCA kal 100 Tosoh/Mono S kal 89 Tosoh/Tosoh kal 100 Variant Turbo/BioRad kal 64 Variant Turbo/MCA kal 100
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Kvalitetsmålet och diagnostik av diabetes Det svenska kvalitetsmålet är tufft! För att använda HbA1c för diagnostik måste kvaliteten vara bra De laboratorier som klarar av resultat i Equalis utskick under 2013 inom kvalitetsmålen har hög kvalitet i sina resultat I så fall OK med diagnostik från och med 2014? 27