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Details : C14RMP1R - IFCC reference method for measurement of the alcohol consumption biomarker CDT
| Type (acronym) | rmp |
|---|---|
| Type | reference measurement procedure |
| Unique Nomination Number | C14RMP1R |
| Analyte Name | P–Disialotransferrin/Transferrin; subst. Fraction |
| IUPAC IFCC Number | CAS11096-37-0 |
| Method capable of Traceability of Analyte to SI or Defined Procedure | Procedurally-defined, see Schellenberg et al ClinChimActa 465 (2017) 91–100 |
| Applicable Matrices | Human serum; fresh or frozen |
| Name | IFCC reference method for measurement of the alcohol consumption biomarker CDT |
| Organization that developed Validated Method | IFCC Working group on CDT Main participating institutes: 1) Karolinska University Laboratory, Stockholm, Sweden 2) Hôpital Trousseau, CHRU, Tours, France 3) Meander Medisch Centrum, Amersfoort, The Netherlands 4) Queen Beatrix Hospital, Winterswijk, The Netherlands 5) Skåne University Hospital, Malmö, Sweden |
| Measurement Techniques Used | Anion-exchange chromatography with gradient elution and UV-VIS detection at 470 nm |
| Quantity | Amount-of-substance fraction expressed in % CDT (disialotransferrine as percentage of total Tf) |
| Level of Confidence (%) | 95% |
| Comments on Concentration Range | The calculated LOD is 0.16 % and the LLOD (based on 5 x SD low sample) is 0.4 %, see Schellenberg CCA 2017. It should be noted that the lower level of the reference range is approx 0.5 % (see Helander CCA 2016 fig 6) and only elevated CDT concentrations (> 1.7 %) are relevant. Hence the limit of detection is far below the the clinical relevant range. The upper limit of the measurement range is 16% of total Tf. See lineairity testing in Schellenberg CCA 2017. |
| Comments on Uncertainty Range | The expanded uncertainty unit is % CDT (% disialotransferrine). The composed method uncertainty is 0.131 applying to CDT results around 2.0 and the expanded uncertainty is 0.257. Uncertainty at higher levels is very similar but not important for the intended use. |
| Peer Reviewed Publication | IFCC approved HPLC reference measurement procedure for the alcohol consumption biomarker carbohydrate-deficient transferrin (CDT): Its validation and use, Schellenberg F. et al, Clinica Chimica Acta 2017 465 91-100 Improved HPLC method for carbohydrate-deficient transferrin in serum, Helander A. et al, Clinical Chemistry 2003 49:11 1881–1890 |
| Additional Comments | Method has been used since about 2005 in many countries for diagnosing alcohol abuse both in medical and forensic settings. EQAS schemes running for up to 15 years in Sweden, France, Netherlands and Germany. Use of the proposed method in standardisation proces is shown in Weykamp et al Clin Chem 2014. A group of reference labs is serving in value assignment of calibrators. A yearly IFCC-EQAS round is organised for certification of commercial methods. See Guiding letter under AN |
| Analyte Category Name | Proteins |
| Measurement principle/technique | High performance liquid chromatography |