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Details : C1RMP_P17 - Reference method for diabetes control and complications trial

Type (acronym)rmp
Typereference measurement procedure
Unique Nomination NumberC1RMP_P17
Analyte NameHbA1c
IUPAC IFCC NumberQU60433
Applicable Matriceswhole blood
NameReference method for diabetes control and complications trial
Organization that developed Validated MethodDCCT
Measurement Techniques UsedCation-exchange HPLC using Bio-Rex 70 resin
QuantityChomatographic peak area fraction of HbA1c
From (0)4
To (0)11
Unit (0)%
From (1)2
To (1)2
Unit (1)%
Level of Confidence (%)95%
Peer Reviewed PublicationGoldstein et al., Measurement of glycosylated hemoglobin: High performance liquid chromatographic and thiobarbituric acid colorimetric methods. In: Methods in diabetes research, Volume II: Clinical Methods, Clarke WL, Larner J and Pohl SL, eds. NY: Wiley and Sons, Inc: 475-504, 1986
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