A Black Swan in clinical laboratory practice: The analytical error due to interferences in immunoassay methods

Cinzia Carrozza, Carla Dotti, Aldo Clerico, Lucia Belloni, Ruggero Dittadi, Claudio Dotti, Antonio Fortunato, Giulio Vignati, Gian Carlo Zucchelli, Marco Migliardi

Risultato della ricerca: Contributo in rivistaArticolo in rivista

14 Citazioni (Scopus)

Abstract

It is well known that the results of immunoassay methods can be affected by specific or non-specific interferences, ranging from 0.4% to 4.0%. The presence of interference may greatly compromise the accuracy of immunoassay analyses causing an error in the measurement, producing false-positive or false-negative results. From a clinical point of view, these analytical errors may have serious implications for patient care because they can cause misdiagnosis or inappropriate treatment. Unfortunately, it is a very difficult task to identify the irregular analytical errors related to immunoassay methods because they are not detectable by normal laboratory quality control procedures, are reproducible within the test system, may be clinically plausible and are relatively rare. The first line of defense against erroneous results is to use in laboratory practice only immunoassay systems with the highest level of robustness against interference. The second line of defense is always taking into account the possibility of interference in immunoassay results. A correct approach should be addressed on identification of samples at high risk of interference. The attainment of this goal requires a critical review of the test result in relation to patient's clinical conditions and literature data, taking into account the analytical characteristics of the immunoassay system. The experts in immunoassay systems should make every effort to find some specific and reliable quality indicators for irregular analytical errors in order to better detect and monitor erroneous immunoassay results due to specific or non-specific interferences.
Lingua originaleEnglish
pagine (da-a)397-402
Numero di pagine6
RivistaClinical Chemistry and Laboratory Medicine
Volume56
DOI
Stato di pubblicazionePubblicato - 2018

Keywords

  • Article
  • Bayesian inference analysis
  • Diagnostic Errors
  • Humans
  • Immunoassay
  • Quality Control
  • analytical error
  • clinical laboratory
  • diagnostic error
  • dimensional measurement accuracy
  • false negative result
  • false positive result
  • human
  • immunoassay
  • immunoassay methods
  • interference
  • laboratory technique
  • patient care
  • patient-centered process
  • priority journal
  • quality control indicators
  • quality control procedures
  • quality control programs
  • quality control, Clinical Laboratory Techniques
  • statistical analysis for quality control

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