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Irregular analytical errors in diagnostic testing – a novel concept

  • Michael Vogeser EMAIL logo und Christoph Seger EMAIL logo
Veröffentlicht/Copyright: 13. September 2017
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Clinical Chemistry and Laboratory Medicine (CCLM)
Aus der Zeitschrift Clinical Chemistry and Laboratory Medicine (CCLM) Band 56 Heft 3

Abstract

Background:

In laboratory medicine, routine periodic analyses for internal and external quality control measurements interpreted by statistical methods are mandatory for batch clearance. Data analysis of these process-oriented measurements allows for insight into random analytical variation and systematic calibration bias over time. However, in such a setting, any individual sample is not under individual quality control. The quality control measurements act only at the batch level. Quantitative or qualitative data derived for many effects and interferences associated with an individual diagnostic sample can compromise any analyte. It is obvious that a process for a quality-control-sample-based approach of quality assurance is not sensitive to such errors.

Content:

To address the potential causes and nature of such analytical interference in individual samples more systematically, we suggest the introduction of a new term called the irregular(individual)analytical error. Practically, this term can be applied in any analytical assay that is traceable to a reference measurement system. For an individual sample an irregular analytical error is defined as an inaccuracy (which is the deviation from a reference measurement procedure result) of a test result that is so high it cannot be explained by measurement uncertainty of the utilized routine assay operating within the accepted limitations of the associated process quality control measurements.

Summary:

The deviation can be defined as the linear combination of the process measurement uncertainty and the method bias for the reference measurement system. Such errors should be coined irregular analytical errors of the individual sample. The measurement result is compromised either by an irregular effect associated with the individual composition (matrix) of the sample or an individual single sample associated processing error in the analytical process.

Outlook:

Currently, the availability of reference measurement procedures is still highly limited, but LC-isotope-dilution mass spectrometry methods are increasingly used for pre-market validation of routine diagnostic assays (these tests also involve substantial sets of clinical validation samples). Based on this definition/terminology, we list recognized causes of irregular analytical error as a risk catalog for clinical chemistry in this article. These issues include reproducible individual analytical errors (e.g. caused by anti-reagent antibodies) and non-reproducible, sporadic errors (e.g. errors due to incorrect pipetting volume due to air bubbles in a sample), which can both lead to inaccurate results and risks for patients.

Keywords: analytical phase; analytical quality; diagnostic errors; laboratory error; laboratory medicine; method bias; patient safety; pre-analytical phase; reference method; risk analysis; total testing process
Corresponding authors: Prof. Dr. med. Michael Vogeser, Institute of Laboratory Medicine, University Hospital, LMU Munich, Germany, Marchioninistr. 15, 81377 München, Germany, Phone: +49 89 4400-73221, Fax: +49 89 4400-76220; and PD Dr. Christoph Seger, labormedizinisches zentrum Dr. Risch, Lagerstrasse 30, 9470 Buchs SG, Switzerland, Phone: +41 58 523 31 50, Fax.: +41 58 523 31 99

  1. Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Research funding: None declared.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. 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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Received: 2017-5-23
Accepted: 2017-7-31
Published Online: 2017-9-13
Published in Print: 2018-2-23

©2018 Walter de Gruyter GmbH, Berlin/Boston

Artikel in diesem Heft

  1. Frontmatter
  2. Editorial
  3. Analytical quality: an unfinished journey
  4. Reviews
  5. Update in diagnosis and management of primary aldosteronism
  6. Diagnosis biomarkers in acute intestinal ischemic injury: so close, yet so far
  7. Opinion Papers
  8. Irregular analytical errors in diagnostic testing – a novel concept
  9. A Black Swan in clinical laboratory practice: the analytical error due to interferences in immunoassay methods
  10. General Clinical Chemistry and Laboratory Medicine
  11. Reaching consensus on communication of critical laboratory results using a collective intelligence method
  12. Stability of routine biochemical analytes in whole blood and plasma/serum: focus on potassium stability from lithium heparin
  13. GFR estimation based on standardized creatinine and cystatin C: a European multicenter analysis in older adults
  14. Binding of bromocresol green and bromocresol purple to albumin in hemodialysis patients
  15. Interlaboratory variability of urinary iodine measurements
  16. The venous thromboembolic risk and the clot wave analysis: a useful relationship?
  17. Hematology and Coagulation
  18. Autovalidation and automation of the postanalytical phase of routine hematology and coagulation analyses in a university hospital laboratory
  19. Reference Values and Biological Variations
  20. Indirect method for validating transference of reference intervals
  21. Differences in levels of albumin, ALT, AST, γ-GT and creatinine in frail, moderately healthy and healthy elderly individuals
  22. Cancer Diagnostics
  23. Serum exosomal hnRNPH1 mRNA as a novel marker for hepatocellular carcinoma
  24. Intragenic hypomethylation of DNMT3A in patients with myelodysplastic syndrome
  25. Cardiovascular Diseases
  26. Evaluation of analytical performance of a new high-sensitivity immunoassay for cardiac troponin I
  27. MEF2C loss-of-function mutation associated with familial dilated cardiomyopathy
  28. Letter to the Editor
  29. Hyperuricemia does not seem to be an independent risk factor for coronary heart disease
  30. Reply to: Hyperuricemia does not seem to be an independent risk factor for coronary heart disease
  31. Preanalytics of ammonia: stability, transport and temperature of centrifugation
  32. Influence of delayed separation of plasma from whole blood on Cu, I, Mn, Se, and Zn plasma concentrations
  33. Copeptin as a diagnostic and prognostic biomarker in patients admitted to Emergency Department with syncope, presyncope and vertiginous syndrome
  34. Development of an internally controlled quantitative PCR to measure total cell-associated HIV-1 DNA in blood
  35. Selective changes in cholesterol metabolite levels in plasma of breast cancer patients after tumor removal
  36. Athletes beware before throwing towels to audiences
https://doi.org/10.1515/cclm-2017-0454
Schlagwörter für diesen Artikel
analytical phase; analytical quality; diagnostic errors; laboratory error; laboratory medicine; method bias; patient safety; pre-analytical phase; reference method; risk analysis; total testing process

Artikel in diesem Heft

  1. Frontmatter
  2. Editorial
  3. Analytical quality: an unfinished journey
  4. Reviews
  5. Update in diagnosis and management of primary aldosteronism
  6. Diagnosis biomarkers in acute intestinal ischemic injury: so close, yet so far
  7. Opinion Papers
  8. Irregular analytical errors in diagnostic testing – a novel concept
  9. A Black Swan in clinical laboratory practice: the analytical error due to interferences in immunoassay methods
  10. General Clinical Chemistry and Laboratory Medicine
  11. Reaching consensus on communication of critical laboratory results using a collective intelligence method
  12. Stability of routine biochemical analytes in whole blood and plasma/serum: focus on potassium stability from lithium heparin
  13. GFR estimation based on standardized creatinine and cystatin C: a European multicenter analysis in older adults
  14. Binding of bromocresol green and bromocresol purple to albumin in hemodialysis patients
  15. Interlaboratory variability of urinary iodine measurements
  16. The venous thromboembolic risk and the clot wave analysis: a useful relationship?
  17. Hematology and Coagulation
  18. Autovalidation and automation of the postanalytical phase of routine hematology and coagulation analyses in a university hospital laboratory
  19. Reference Values and Biological Variations
  20. Indirect method for validating transference of reference intervals
  21. Differences in levels of albumin, ALT, AST, γ-GT and creatinine in frail, moderately healthy and healthy elderly individuals
  22. Cancer Diagnostics
  23. Serum exosomal hnRNPH1 mRNA as a novel marker for hepatocellular carcinoma
  24. Intragenic hypomethylation of DNMT3A in patients with myelodysplastic syndrome
  25. Cardiovascular Diseases
  26. Evaluation of analytical performance of a new high-sensitivity immunoassay for cardiac troponin I
  27. MEF2C loss-of-function mutation associated with familial dilated cardiomyopathy
  28. Letter to the Editor
  29. Hyperuricemia does not seem to be an independent risk factor for coronary heart disease
  30. Reply to: Hyperuricemia does not seem to be an independent risk factor for coronary heart disease
  31. Preanalytics of ammonia: stability, transport and temperature of centrifugation
  32. Influence of delayed separation of plasma from whole blood on Cu, I, Mn, Se, and Zn plasma concentrations
  33. Copeptin as a diagnostic and prognostic biomarker in patients admitted to Emergency Department with syncope, presyncope and vertiginous syndrome
  34. Development of an internally controlled quantitative PCR to measure total cell-associated HIV-1 DNA in blood
  35. Selective changes in cholesterol metabolite levels in plasma of breast cancer patients after tumor removal
  36. Athletes beware before throwing towels to audiences
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