Extra-analytical sources of uncertainty: which ones really matter?
-
Andrea Padoan
,
Laura Sciacovelli
,
Rui Zhou
Abstract
Since the endorsement by ISO15189:2012 of measurement uncertainty (MU) for the estimation of error in measurement procedures, the debate has been ongoing with questions concerning which method should be used for estimating MU and the benefits of using MU over other error methods. However, only limited attention has been given to extra-analytical sources of uncertainty and, currently, a clear standpoint is still missing. This opinion paper aims to evaluate whether extra-analytical variables could be included in MU. Considering coagulation tests as an example, the possible sources of preanalytical variations are evaluated by using a fishbone diagram. After excluding preanalytical errors, additional sources of uncertainty are divided into amenable to standardization/harmonization and/or possible random sources, which are not standardizable nor harmonizable. Finally, sources of uncertainty are evaluated for a possible inclusion into MU. In addition, postanalytical uncertainty is discussed, particularly considering the laboratory results calculated through a mathematical equation, derived from one or more quantities affected by their specific uncertainty.
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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©2019 Walter de Gruyter GmbH, Berlin/Boston
Articles in the same Issue
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Articles in the same Issue
- Frontmatter
- Editorial
- Blood biomarkers in neurology: “a call to arms” for laboratory professionals
- Reviews
- Diagnostic accuracy of glycated hemoglobin for gestational diabetes mellitus: a systematic review and meta-analysis
- Laboratory medicine: health evaluation in elite athletes
- Prostate cancer screening: guidelines review and laboratory issues
- Opinion Papers
- Extra-analytical sources of uncertainty: which ones really matter?
- Benefits and harms of wellness initiatives
- Genetics and Molecular Diagnostics
- Analytical and clinical validation of a novel amplicon-based NGS assay for the evaluation of circulating tumor DNA in metastatic colorectal cancer patients
- General Clinical Chemistry and Laboratory Medicine
- Pre-analytical practices for routine coagulation tests in European laboratories. A collaborative study from the European Organisation for External Quality Assurance Providers in Laboratory Medicine (EQALM)
- Preanalytical robustness of blood collection tubes with RNA stabilizers
- Continual improvement of the pre-analytical process in a public health laboratory with quality indicators-based risk management
- Comparison of six commercial serum exosome isolation methods suitable for clinical laboratories. Effect in cytokine analysis
- A multicenter study to evaluate harmonization of assays for N-terminal propeptide of type I procollagen (PINP): a report from the IFCC-IOF Joint Committee for Bone Metabolism
- Correlations between serum and CSF pNfH levels in ALS, FTD and controls: a comparison of three analytical approaches
- Dynamics of extracellular matrix proteins in cerebrospinal fluid and serum and their relation to clinical outcome in human traumatic brain injury
- Free light chains in the cerebrospinal fluid. Comparison of different methods to determine intrathecal synthesis
- Reference Values and Biological Variations
- Reference interval by the indirect approach of serum thyrotropin (TSH) in a Mediterranean adult population and the association with age and gender
- Next-generation reference intervals for pediatric hematology
- Hematology and Coagulation
- Preliminary evaluation of a new flow cytometry method for the routine hematology workflow
- Diabetes
- Trueness assessment of HbA1c routine assays: are processed EQA materials up to the job?
- Infectious Diseases
- Utility of procalcitonin for differentiating cryptogenic organising pneumonia from community-acquired pneumonia
- A high C-reactive protein/procalcitonin ratio predicts Mycoplasma pneumoniae infection
- Letters to the Editor
- Evaluation of reference change values for a hs-cTnI immunoassay using both plasma samples of healthy subjects and patients and quality control samples
- Outlier removal methods for skewed data: impact on age-specific high-sensitive cardiac troponin T 99th percentiles
- Comparison of precision and operational performances across six immunochemistry analyzers
- Evaluation of the possible interference of abiraterone therapy on testosterone immunoassay
- Erroneous thyroid and steroid hormones profile due to anti-streptavidin antibodies
- Reference values for 24,25-dihydroxyvitamin D and the 25-hydroxyvitamin D/24,25-dihydroxyvitamin D ratio
- Pre-analytical error in a hematology laboratory: an avoidable cause of compromised quality in reporting
- Stability of tubular damage markers epidermal growth factor and heparin-binding EGF-like growth factor in urine
- Blood from heparin tubes is an acceptable alternative to assess hematocrit determination
