An approach for estimating measurement uncertainty in medical laboratories using data from long-term quality control and external quality assessment schemes
-
Andrea Padoan
,
Giorgia Antonelli
Abstract
Background:
The present study was prompted by the ISO 15189 requirements that medical laboratories should estimate measurement uncertainty (MU).
Methods:
The method used to estimate MU included the: a) identification of quantitative tests, b) classification of tests in relation to their clinical purpose, and c) identification of criteria to estimate the different MU components. Imprecision was estimated using long-term internal quality control (IQC) results of the year 2016, while external quality assessment schemes (EQAs) results obtained in the period 2015–2016 were used to estimate bias and bias uncertainty.
Results:
A total of 263 measurement procedures (MPs) were analyzed. On the basis of test purpose, in 51 MPs imprecision only was used to estimate MU; in the remaining MPs, the bias component was not estimable for 22 MPs because EQAs results did not provide reliable statistics. For a total of 28 MPs, two or more MU values were calculated on the basis of analyte concentration levels. Overall, results showed that uncertainty of bias is a minor factor contributing to MU, the bias component being the most relevant contributor to all the studied sample matrices.
Conclusions:
The model chosen for MU estimation allowed us to derive a standardized approach for bias calculation, with respect to the fitness-for-purpose of test results. Measurement uncertainty estimation could readily be implemented in medical laboratories as a useful tool in monitoring the analytical quality of test results since they are calculated using a combination of both the long-term imprecision IQC results and bias, on the basis of EQAs results.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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Artikel in diesem Heft
- Frontmatter
- Editorial
- High-sensitivity assays for cardiac troponins – continued
- Reviews
- The 99th percentile of reference population for cTnI and cTnT assay: methodology, pathophysiology and clinical implications
- Vitamin B1 in critically ill patients: needs and challenges
- Opinion Papers
- Point
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- Counterpoint
- Terminology of cardiac troponin assays and data censoring
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- Fast track protocols using highly sensitive troponin assays for ruling out and ruling in non-ST elevation acute coronary syndrome
- Genetics and Molecular Diagnostics
- Relationship between polymorphisms in the CRP, LEP and LEPR genes and high sensitivity C-reactive protein levels in Spanish children
- General Clinical Chemistry and Laboratory Medicine
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- Selecting multi-rule quality control procedures based on patient risk
- Moving sum of number of positive patient result as a quality control tool
- Multidisciplinary training activities for decreasing preanalytical mistakes in samples from primary care
- Harmonization protocols for TSH immunoassays: a multicenter study in Italy
- Circulating free light chain measurement in the diagnosis, prognostic assessment and evaluation of response of AL amyloidosis: comparison of Freelite and N latex FLC assays
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