The IFCC HbA 2 standardization
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1 The IFCC HbA 2 standardization program Andrea Mosca Centro Interdipartimentale per la Riferibilità Metrologica in Medicina di Laboratorio (CIRME) Dip. di Scienze e Tecnologie Biomediche Università degli Studi di Milano Milano, Italy andrea.mosca@unimi.it
2 agenda Terms of reference and metrological traceability Primary and secondary reference measurement procedure Primary and secondary reference materials WHO and ICSH interactions How accurate should we be?
3
4 blood new SOP (under development) erythrocytes hemolysate enzymatic cleavage with trypsin +ISδ 5 13 C + ISα 5 13 C HPLC - Mass spectrometry quantification of specific peptides δt2 (TAVNALWGK) and αt11 (VDPVNFK)
5 P.Kaiser and H. Reinauer are going to develop the same approach for HbA2 Next report: meeting in January 2012 A. Mosca - UniMI 5
6 The δ chain/α chain ratio as a surrogate biomarker for HbA 2 6
7 July 2011 April 2011 A. Mosca - UniMI 7
8 Secondary measurement procedure for HbA 2 based on quantification of tryptic peptides RN Neil ildalton, Yvonne Daniel, Charles Turner WellChild Laboratory King s College London/Evelina Children s Hospital IFCC Working Group on Standardisation of HbA 2 Meeting IFCC Euromedlab 2011, Berlin
9 Secondary measurement procedure for HbA 2 based on quantification of tryptic peptides The delta chain/beta chain ratio as a surrogate biomarker for HbA 2 Daniel et al, Clin Chem 2007;53: News, 19 September 2011: the method is ready to be transferred to the other MS labs of the WG wishing to test it, providing a license A. Mosca - UniMI and coverage of the costs for the labeled 9 peptides
10 Second batch prepared at the IRMM on July 2011 (from materials sent to them on November 2010) Call for tenders under development: Testing Methemoglobin formation during storage over one year Minor Hbs analysis by capillary electrophoresis or HPLC Testing total Hb content A. Mosca - UniMI 10
11 Issues about the WHO material: a) Just one level of HbA 2 (5.3 %) b) Title assigned by LC (minicolumns?) c) No data on the commutability d) No data on stability e) No information about how the manufacturers are using it f) Usually handled differently from blood samples A. Mosca - UniMI 11
12 NIBSC-WHO material Bio-Rad Variant II Tosoh G8 A. Mosca - UniMI 12
13 Fresh whole blood Bio-Rad Variant II Tosoh G8 A. Mosca - UniMI 13
14 Experimental protocol N = 18 healthy subjects N = 9 Men N = 9 Women Age: y Five blood samples (every 2 weeks for 2 months) Parameters: HbA 1c, glycated albumin, fructosamine, HbA 2 RBC, WBC, PLT, Hb, MCH, MCHC, MCV, RDW Measurements on fresh blood samples and storage at - 80 C Analysis by HPLC, NGSP calibrated (HbA 1c ) A. Mosca - UniMI 14
15 Data analysis σ 2 total = σ 2 anal + σ 2 I + σ 2 G Analytical variation: from the duplicate results for each specimen or from internal QC (whole blood cell count) Intra-individual variation: from the serial results for each subject Inter-individual variation: from the total variance of data, minus the analytical and intra-individual components A. Mosca - UniMI 15
16 Raw data, HbA 2
17 HbA 2 Analytical Quality level goal Minimal Desirable Optimal Imprecision, % Bias, % Total error, %
18 Take-home message The biological variability of glycated Hb is small, that of HbA 2 is even smaller CV I is < than CV G : limit to the use of reference intervals based on populations The analytical goal for CV a is very stringent EQAS and IQC are essential in order to keep under strict control the HbA 2 methods A. Mosca - UniMI 18
19 Aknowledgments Renata Paleari (University of Milano, Milano) (HPLC analysis, data elaboration) Martina Montagnana, Giancesare Guidi (Verona University Hospital, Verona) (protocol, subjects) A. Mosca - UniMI 19
20 20 th IFCC Looking forward to meeting you at EUROMEDLAB Milano 2013 IFCC EFCC European Congress of Clinical Chemistry and Laboratory Medicine A. Mosca - UniMI 20
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