References
- ISO 17511:2003, In vitro diagnostic medical devices – Measurement of quantities in biological samples–Metrological traceability of values assigned to calibrators and control materials, International Organization for Standardization, Genève.
- ISO 18153:2003, In vitro diagnostic medical devices– Measurement of quantities in biological samples–Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials, International Organization for Standardization, Genève.
- Miedema K. Standardisation of HbA1c and optimal range of monitoring. Scand J Clin Lab Invest Suppl, 240;(2005):61–72.
- Sturgeon CM, Berger P, Bidart J-M, Birkin S, Burns C, Norman RJ, . Differences in Recognition of the 1st WHO International Reference Reagents for hCG-Related Isoforms by Diagnostic Immunoassays for Human Chorionic Gonadotropin. Clin Chem (2009);55(8):1484–1491.
- Panteghini M, Gerhardt W, Apple FS, Dati F, Ravkilde J, Wu AH. Quality specifications for cardiac troponin assays. International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). Clin Chem Lab Med 2001; 39:174–8.
- CLSI C53-P, Characterisation and Quantification of Commutable Reference Materials for Laboratory Medicine; Proposed Guideline, Clinical Laboratory Standards Institute, ISBN 1-562238-678-6.
- Zegers I, Schreiber W, Munoz-Pineiro A, Sheldon J, Merlini G, Itoh Y, . Certification of proteins in the human serum, ERM-DA470k/IFCC, EUR 23431 EN, European Communities, Luxembourg, 2008, ISBN 978-92-79-094903.
- Baudner S, Bienvenu J, Blirup-Jensen S, Carlström A, Johnsen AM, Milfor A . The certification of a matrix reference material for immunochemical measurement of 14 human serum proteins CRM470, EUR 15431 EN and complement EUR 16882 EN (ISBN 92-827-7337-X), European Communities, Luxembourg, 1993.
- Zegers I, Schreiber W, Sheldon J, Linstead S, Merlini SG, Charoud-Got J, . Certification of C-reactive protein in reference material ERM-DA472/IFCC, EUR 23756 EN, European Communities, Luxembourg, 2009, ISBN 978-92-79-11326-0.
- ISO Guide 31:2000, Reference materials–Contents of certificates and labels, International Organization for Standardization, Genève.
- ISO Guide 33:2000, Uses of certified reference materials, International Organization for Standardization, Genève.
- ISO Guide 34:2009, General requirements for the competence of reference material producers, International Organization for Standardization, Genève.
- ISO 15194:2009, In vitro diagnostic medical devices– Measurement of quantities in samples of biological origin–Requirements for certified reference materials and the content of supporting documentation, International Organization for Standardization, Genève.
- Blirup-Jensen S, Johnson AM, Larsen M, Protein standardization V: value transfer. A practical protocol for the assignment of serum protein values from a Reference Material to a Target Material. Clin Chem Lab Med 2008;46(10): 1470–1479.