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

Aldo Clerico, Lucia Belloni, Cinzia Carrozza, Mario Correale, Ruggero Dittadi, Claudio Dotti, Antonio Fortunato, Giulio Vignati, Gian Carlo Zucchelli, Marco Migliardi, a document endorsed by the Italian Section of the European Ligand Assay Society (ELAS)

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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.

Original languageEnglish
Pages (from-to)397-402
Number of pages6
JournalClinical Chemistry and Laboratory Medicine
Issue number3
Publication statusPublished - Feb 23 2018


  • Journal Article


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