Criteria for assigning laboratory measurands to models for analytical performance specifications defined in the 1st EFLM Strategic Conference
Articolo
Data di Pubblicazione:
2017
Citazione:
Criteria for assigning laboratory measurands to models for analytical performance specifications defined in the 1st EFLM Strategic Conference / F. Ceriotti, P. Fernandez Calle, G.G. Klee, G. Nordin, S. Sandberg, T. Streichert, J.L. Vives Corrons, M. Panteghini. - In: CLINICAL CHEMISTRY AND LABORATORY MEDICINE. - ISSN 1434-6621. - 55:2(2017), pp. 189-194. [10.1515/cclm-2016-0091]
Abstract:
This paper, prepared by the EFLM Task and Finish Group on Allocation of laboratory tests to different models for performance specifications (TFG-DM), is dealing with criteria for allocating measurands to the different models for analytical performance specifications (APS) recognized in the 1st EFLM Strategic Conference Consensus Statement. Model 1, based on the effect of APS on clinical outcome, is the model of choice for measurands that have a central role in the decision-making of a specific disease or clinical situation and where cutoff/decision limits are established for either diagnosing, screening or monitoring. Total cholesterol, glucose, HbA1c, serum albumin and cardiac troponins represent practical examples. Model 2 is based on components of biological variation and should be applied to measurands that do not have a central role in a specific disease or clinical situation, but where the concentration of the measurand is in a steady state. This is best achieved for measurands
under strict homeostatic control in order to preserve their concentrations in the body fluid of interest, but it can also be applied to other measurands that are in a steady state in biological fluids. In this case, it is expected that the “noise” produced by the measurement procedure will
not significantly alter the signal provided by the concentration of the measurand. This model especially applies to electrolytes and minerals in blood plasma (sodium, potassium, chloride, bicarbonate, calcium, magnesium, inorganic phosphate) and to creatinine, cystatin C, uric
acid and total protein in plasma. Model 3, based on stateof-the-art of the measurement, should be used for all the measurands that cannot be included in models 1 or 2.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
analytical performance specifications; analytical quality; biological variation
Elenco autori:
F. Ceriotti, P. Fernandez Calle, G.G. Klee, G. Nordin, S. Sandberg, T. Streichert, J.L. Vives Corrons, M. Panteghini
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