12/27/2023 0 Comments Model chemlab![]() Therefore, the definition of an allowable MU is essential to ascertain if estimated MU for a given laboratory result may significantly affect its interpretation,. Very important to the scope of the present paper, the ISO Technical Specification 20914 dealing with the MU estimation also emphasizes that the magnitude of MU should be suitable for a result to be used in a medical decision. MU at the level of clinical samples should be the combination of all uncertainty contributions accumulated across the entire traceability chain, starting with MU of reference materials, extending through the in vitro diagnostic (IVD) manufacturers and their process for assignment of calibrator values and MU, and ending with the random variability of measuring systems. Recently published documents have recommended how medical laboratories should correctly estimate MU, basically endorsing the so-called “top–down” approach using appropriate internal quality control (IQC) data and commercial calibrator information. Particularly, to make laboratory determinations clinically usable and to ensure that the measurement variability does not gain the upper hand obscuring the clinical information supplied by the test results, it is essential to estimate the measurement uncertainty (MU) of results produced by procedures intended to measure biological measurands, and to verify that the estimated MU is within objectively defined analytical performance specifications (APS). The main scope of laboratory medicine is to provide useful information for correct clinical decision-making in order to significantly contribute to the quality of health care. ![]() ConclusionsĪPS for MU of clinical samples derived in this study are essential to objectively evaluate the reliability of results provided by medical laboratories. For C-reactive protein, allocated to the model 3, a desirable MU of 3.76% was defined. Plasma potassium, sodium, chloride, total calcium, alanine aminotransferase, creatinine, urea, and total bilirubin were allocated to the model 2 and the corresponding desirable APS were 1.96, 0.27, 0.49, 0.91, 4.65, 2.20, 7.05, and 10.5%, respectively. Resultsīlood total hemoglobin, plasma glucose, blood glycated hemoglobin, and serum 25-hydroxyvitamin D3 were allocated to the model 1 and the corresponding desirable APS were 2.80, 2.00, 3.00, and 10.0%, respectively. Both minimum and desirable levels of quality of APS for standard MU of clinical samples were defined by using information obtained from available studies. We allocated a group of 13 measurands selected among the most commonly laboratory requested tests to each of the three Milan models on the basis of their biological and clinical characteristics. Using these models appropriately, we present here a proposal for defining APS for standard MU for some common biochemical measurands. The 2014 Milan Strategic Conference have proposed models to objectively derive APS based on: (a) the effect of analytical performance on clinical outcome (b) biological variation components and (3) the state of the art of the measurement, defined as the highest level of analytical performance technically achievable. ![]() Definition and fullfillment of analytical performance specifications (APS) for measurement uncertainty (MU) allow to make laboratory determinations clinically usable. ![]()
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