A Black Swan in clinical laboratory practice: the analytical error due to interferences in immunoassay methods
Autor: | Marco Migliardi, Aldo Clerico, Lucia Belloni, Claudio Dotti, Antonio Fortunato, Mario Correale, Giulio Vignati, Ruggero Dittadi, Cinzia Carrozza, Gian Carlo Zucchelli |
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Rok vydání: | 2017 |
Předmět: |
Quality Control
030213 general clinical medicine First line Clinical Biochemistry interference patient-centered process 030204 cardiovascular system & hematology diagnostic error Interference (wave propagation) computer.software_genre Article 03 medical and health sciences 0302 clinical medicine Second line Settore BIO/12 - BIOCHIMICA CLINICA E BIOLOGIA MOLECOLARE CLINICA false positive result Robustness (computer science) medicine clinical laboratory false negative result Humans human quality control indicators Diagnostic Errors analytical error quality control Clinical Laboratory Techniques Immunoassay medicine.diagnostic_test Clinical Laboratory Techniques Biochemistry (medical) Normal laboratory patient care Quality control General Medicine statistical analysis for quality control quality control programs Identification (information) immunoassay methods priority journal quality control procedures laboratory technique Data mining dimensional measurement accuracy computer Bayesian inference analysis |
Zdroj: | Clinical chemistry and laboratory medicineReferences. 56(3) |
ISSN: | 1437-4331 |
Popis: | 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. |
Databáze: | OpenAIRE |
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