The medical laboratory results of e.g. a blood test must be interpreted to give information about a patient's health. To do this the doctor consults information on normal ranges of such results. Establishing those normal ranges requires that the diagnostics results from the different laboratories are comparable and correct. In addition the quality of the individual results has to be high enough to enable the doctor to make the right decisions.
Making laboratory results comparable over different hospitals and over time requires standardisation, using reference materials and methods. The need for standardisation and traceability is taken up in the EU Directive on In Vitro Diagnostic Medical Devices (IVD-MD) (Directive 98/79/EC).
Standardisation of the methods used in medical laboratories and assuring the quality of diagnostics results, is a global effort. The JRC-IRMM has the expertise to develop reference materials, but also coordinates the input from the clinical chemistry profession, the In Vitro Diagnostics industry and hospital clinicians in order to produce CRMs that are accepted internationally.
JRC-IRMM carries out extensive research to develop and produce suitable reference materials for complex biomarkers. As a result, over 40 different enzyme and protein reference materials are available, including those for tumour markers, and markers for infectious diseases and cardiac damage. Genetic testing and e.g. the standardisation of tests for autoimmune disease introduce new demands for IRMM to respond to.
Examples of recently released CRMs:
ERM-AD457/IFCC: certified for aspartate transaminase (AST)
ERM-DA470k/IFCC: certified for 12 proteins (e.g. albumin, IgG, IgM, …)
ERM-DA474/IFCC: certified for C-reactive protein (CRP)
Recent publications:
Standardizing plasma protein measurements worldwide: a challenging enterprise.
Merlini G, Blirup-Jensen S, Johnson AM, Sheldon J, Zegers I. Clin Chem Lab Med 2010;48:1567-75.
First certified reference material for cystatin Cin human serum : ERM-DA471/IFCC
Grubb A, Blirup-Jensen S, Lindström V, Schmidt C, Althaus H, Zegers I; IFCC Working Group on Standardisation of Cystatin C (WG-SCC).
Clin Chem Lab Med. 2010 Nov;48(11):1619-21.
Standardization of protein biomarker measurements:
Schimmel H, Zegers I, Emons H. Scand J Clin Lab Invest Suppl. 2010 Jul;242:27-33.
Traceability of values for catalytic activity concentration of enzymes: a Certified Reference Material for aspartate transaminase.
Toussaint B, Emons H, Schimmel HG, Bossert-Reuther S, Canalias F, Ceriotti F, Férard G, Ferrero CA, Franck PF, Gella FJ, Henny J, Jørgensen PJ, Klauke R, Lessinger JM, Mazziotta D, Panteghini M, Ueda S, Schumann G. Clin Chem Lab Med. 2010 Jun;48(6):795-803.
Quantification of protein calibrants by amino acid analysis using isotope dilution mass spectrometry.
Muñoz A, Kral R, Schimmel H. Anal Biochem. 2011 Jan 1;408(1):124-31.