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
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