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Details : C1RMP_P16_MS - IFCC method for HbA1c (HPLC / MS-ESI)

Type (acronym)rmp
Typereference measurement procedure
Unique Nomination NumberC1RMP_P16_MS
Analyte NameHbA1c
IUPAC IFCC NumberQU60433
Applicable Matriceswhole blood
NameIFCC method for HbA1c (HPLC / MS-ESI)
Organization that developed Validated MethodIFCC
Measurement Techniques UsedHemoglobin samples treated with endoproteinase Glu-C followed by HPLC and electrospray ionisation mass spectrometry (ESI-MS)
QuantityAmount-of-substance fraction of [HbA1c/(HbA1c+HbA0)] expressed in mmol/mol
From (0)0
To (0)140
Unit (0)mmol/mol
From (1)1
To (1)1
Unit (1)%
Peer Reviewed PublicationKaiser P. et al., Modification of the IFCC reference measurement procedure for determination of HbA1c by HPLC-ESI-MS, GMS Ger. Med. Sci., 2006, Doc. 06. Jeppsson J-O et al., Approved IFCC reference method for the measurement of HbA1c in human blood, Clin. Chem. Lab. Med., 2002, 40, 78-89 A modification of the method as described in Clin. Chem., 2008, 54, 1018-22 has been accepted by the IFCC network and is currently used by the IFCC network Laboratories.
Review Team Nameproteins
Analyte Category NameProteins
Non-CCQM Key Comparison ReportThere are three proposed reference measurement procedures listed for HbA1c. One, based on chromatography has been the reference used for a number of years. Two more recent procedures (endorsed by the IFCC) more rigorously determine the amount-of-substance ratio of HbA1c and have been proposed to replace earlier method. The methods have been demonstrated to correlate (precisely) with one another but result in different reference values and limits. While the IFCC recommended procedures might be considered higher methods relative to the chromatographic method, all are higher order to a manufacturer's method. The Master Conversion Equation for relation between the IFCC numbers and the respective national Designated Comparisons Methods was published in Clinical Chemistry, 2004, 50, N°1, 166-174.
Non-CCQM Key Comparison Report Hyperlink
Measurement principle/techniqueHigh performance liquid chromatography