Criteria for assigning laboratory measurands to models for analytical performance specifications defined in the 1st EFLM Strategic Conference

TY - JOUR

T1 - Criteria for assigning laboratory measurands to models for analytical performance specifications defined in the 1st EFLM Strategic Conference

AU - Ceriotti, Ferruccio

AU - Fernandez-Calle, Pilar

AU - Klee, George G

AU - Nordin, Gunnar

AU - Sandberg, Sverre

AU - Streichert, Thomas

AU - Vives-Corrons, Joan-Lluis

AU - Panteghini, Mauro

PY - 2017/2/1

Y1 - 2017/2/1

N2 - 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 cut-off/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 state-of-the-art of the measurement, should be used for all the measurands that cannot be included in models 1 or 2.

AB - 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 cut-off/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 state-of-the-art of the measurement, should be used for all the measurands that cannot be included in models 1 or 2.

KW - Blood Chemical Analysis

KW - Cholesterol

KW - Clinical Laboratory Techniques

KW - Creatinine

KW - Cystatin C

KW - Electrolytes

KW - Glucose

KW - Glycated Hemoglobin A

KW - Humans

KW - Minerals

KW - Serum Albumin

KW - Troponin

KW - Uric Acid

KW - Journal Article

U2 - 10.1515/cclm-2016-0091

DO - 10.1515/cclm-2016-0091

M3 - SCORING: Journal article

C2 - 27506603

VL - 55

SP - 189

EP - 194

JO - CLIN CHEM LAB MED

JF - CLIN CHEM LAB MED

SN - 1434-6621

IS - 2

ER -