La stima dell'incertezza delle misure nel laboratorio clinico

Translated title of the contribution: Measurement uncertainty calculation in clinical laboratories

Duilio Brugnoni, Roberto Guerranti, Pasquale Iandolo, Sonia Mattioli, Cosimo Ottomano, Ferruccio Ceriotti

Research output: Contribution to journalArticle

Abstract

The result of a measurement is only an estimate of the value of the measurand and it is complete only when accompanied by a statement of the measurement uncertainty. The ISO 15189 standard requires that "the laboratory shall determine measurement uncertainty for each measurement procedure". The approach to calculate the measurement uncertainty proposed by the "Guide to the expression of uncertainty in measurement" (GUM) requires the quantification of every source of variability to sum them up for the final calculation ("bottom-up" approach). To overcome inherent difficulties in the systematic application of this approach in a clinical laboratory, a "top-down" approach is proposed, through the calculation of measurement uncertainty from already existing data of IQC. The proposed approach is checked by applying it to the IQC data for serum glucose and creatinine measurements collected from 19 clinical laboratories. Different approaches to cope with the issue of the estimate of systematic error (bias) are proposed, based either on value-assigned trueness control/reference materials, on the mean value of the employed material defined by the laboratory at the start of the IQC program or on the peer group mean of an interlaboratory program material. The availability of a standardized way to estimate the measurement uncertainty provides a tool to evaluate the analytical quality of results and it allows comparison of the quality of results made available by different laboratories.

Original languageItalian
Pages (from-to)108-115
Number of pages8
JournalBiochimica Clinica
Volume39
Issue number2
Publication statusPublished - 2015

Fingerprint

Clinical laboratories
Uncertainty
Peer Group
Creatinine
Systematic errors
Glucose
Serum
Availability

ASJC Scopus subject areas

  • Clinical Biochemistry
  • Biochemistry, medical
  • Medical Laboratory Technology

Cite this

Brugnoni, D., Guerranti, R., Iandolo, P., Mattioli, S., Ottomano, C., & Ceriotti, F. (2015). La stima dell'incertezza delle misure nel laboratorio clinico. Biochimica Clinica, 39(2), 108-115.

La stima dell'incertezza delle misure nel laboratorio clinico. / Brugnoni, Duilio; Guerranti, Roberto; Iandolo, Pasquale; Mattioli, Sonia; Ottomano, Cosimo; Ceriotti, Ferruccio.

In: Biochimica Clinica, Vol. 39, No. 2, 2015, p. 108-115.

Research output: Contribution to journalArticle

Brugnoni, D, Guerranti, R, Iandolo, P, Mattioli, S, Ottomano, C & Ceriotti, F 2015, 'La stima dell'incertezza delle misure nel laboratorio clinico', Biochimica Clinica, vol. 39, no. 2, pp. 108-115.
Brugnoni D, Guerranti R, Iandolo P, Mattioli S, Ottomano C, Ceriotti F. La stima dell'incertezza delle misure nel laboratorio clinico. Biochimica Clinica. 2015;39(2):108-115.
Brugnoni, Duilio ; Guerranti, Roberto ; Iandolo, Pasquale ; Mattioli, Sonia ; Ottomano, Cosimo ; Ceriotti, Ferruccio. / La stima dell'incertezza delle misure nel laboratorio clinico. In: Biochimica Clinica. 2015 ; Vol. 39, No. 2. pp. 108-115.
@article{3b01c32894574d92b9b3feaf07c412f5,
title = "La stima dell'incertezza delle misure nel laboratorio clinico",
abstract = "The result of a measurement is only an estimate of the value of the measurand and it is complete only when accompanied by a statement of the measurement uncertainty. The ISO 15189 standard requires that {"}the laboratory shall determine measurement uncertainty for each measurement procedure{"}. The approach to calculate the measurement uncertainty proposed by the {"}Guide to the expression of uncertainty in measurement{"} (GUM) requires the quantification of every source of variability to sum them up for the final calculation ({"}bottom-up{"} approach). To overcome inherent difficulties in the systematic application of this approach in a clinical laboratory, a {"}top-down{"} approach is proposed, through the calculation of measurement uncertainty from already existing data of IQC. The proposed approach is checked by applying it to the IQC data for serum glucose and creatinine measurements collected from 19 clinical laboratories. Different approaches to cope with the issue of the estimate of systematic error (bias) are proposed, based either on value-assigned trueness control/reference materials, on the mean value of the employed material defined by the laboratory at the start of the IQC program or on the peer group mean of an interlaboratory program material. The availability of a standardized way to estimate the measurement uncertainty provides a tool to evaluate the analytical quality of results and it allows comparison of the quality of results made available by different laboratories.",
author = "Duilio Brugnoni and Roberto Guerranti and Pasquale Iandolo and Sonia Mattioli and Cosimo Ottomano and Ferruccio Ceriotti",
year = "2015",
language = "Italian",
volume = "39",
pages = "108--115",
journal = "Biochimica Clinica",
issn = "0393-0564",
publisher = "CLAS International",
number = "2",

}

TY - JOUR

T1 - La stima dell'incertezza delle misure nel laboratorio clinico

AU - Brugnoni, Duilio

AU - Guerranti, Roberto

AU - Iandolo, Pasquale

AU - Mattioli, Sonia

AU - Ottomano, Cosimo

AU - Ceriotti, Ferruccio

PY - 2015

Y1 - 2015

N2 - The result of a measurement is only an estimate of the value of the measurand and it is complete only when accompanied by a statement of the measurement uncertainty. The ISO 15189 standard requires that "the laboratory shall determine measurement uncertainty for each measurement procedure". The approach to calculate the measurement uncertainty proposed by the "Guide to the expression of uncertainty in measurement" (GUM) requires the quantification of every source of variability to sum them up for the final calculation ("bottom-up" approach). To overcome inherent difficulties in the systematic application of this approach in a clinical laboratory, a "top-down" approach is proposed, through the calculation of measurement uncertainty from already existing data of IQC. The proposed approach is checked by applying it to the IQC data for serum glucose and creatinine measurements collected from 19 clinical laboratories. Different approaches to cope with the issue of the estimate of systematic error (bias) are proposed, based either on value-assigned trueness control/reference materials, on the mean value of the employed material defined by the laboratory at the start of the IQC program or on the peer group mean of an interlaboratory program material. The availability of a standardized way to estimate the measurement uncertainty provides a tool to evaluate the analytical quality of results and it allows comparison of the quality of results made available by different laboratories.

AB - The result of a measurement is only an estimate of the value of the measurand and it is complete only when accompanied by a statement of the measurement uncertainty. The ISO 15189 standard requires that "the laboratory shall determine measurement uncertainty for each measurement procedure". The approach to calculate the measurement uncertainty proposed by the "Guide to the expression of uncertainty in measurement" (GUM) requires the quantification of every source of variability to sum them up for the final calculation ("bottom-up" approach). To overcome inherent difficulties in the systematic application of this approach in a clinical laboratory, a "top-down" approach is proposed, through the calculation of measurement uncertainty from already existing data of IQC. The proposed approach is checked by applying it to the IQC data for serum glucose and creatinine measurements collected from 19 clinical laboratories. Different approaches to cope with the issue of the estimate of systematic error (bias) are proposed, based either on value-assigned trueness control/reference materials, on the mean value of the employed material defined by the laboratory at the start of the IQC program or on the peer group mean of an interlaboratory program material. The availability of a standardized way to estimate the measurement uncertainty provides a tool to evaluate the analytical quality of results and it allows comparison of the quality of results made available by different laboratories.

UR - http://www.scopus.com/inward/record.url?scp=84943232016&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84943232016&partnerID=8YFLogxK

M3 - Articolo

AN - SCOPUS:84943232016

VL - 39

SP - 108

EP - 115

JO - Biochimica Clinica

JF - Biochimica Clinica

SN - 0393-0564

IS - 2

ER -