Comparison of Two Clinical Chemistry Analyzers by Total Analytical Error and Measurement Uncertainty

Abstract

Background: Although analytical errors contain a small portion of laboratory errors, they are important in terms of intervention ability and practicality of follow-up by laboratory professionals. Also, from this point of view, the test results' quality, reliability, and accuracy are crucial to laboratories. Therefore, to determine analytical per-formance parameters for quality management in the analytical phase, clinical laboratories utilize total analytical error (TAE), bias, coefficient of variation (CV), and uncertainty of measurement (MU). Methods: Fifteen biochemistry parameters were compared with Beckman Coulter AU 5800 for 2017 -2018 and Roche Cobas 8000 for 2019 -2020 in terms of TAE and MU. The results were evaluated between devices and com-pared with the EuBIVAS, CLIA, RCPA, PRDEQA%, pUQEAS%, pU%, and TEa-TR datasets.Results: There were no significant differences between the devices for the mentioned periods. Device performances resulted in similar outcomes. During our four-year study, nearly all of our tests failed for EuBIVAS, RCPA, and pU%. On the contrary, almost all of our parameters gave valid results according to the CLIA, PRDEQA%, pUQEAS%, and TEa-TR ranges.Conclusions: It is crucial to distinguish between mistake and uncertainty. The discrepancy between the mea-sured value and the 'actual value' is called error. Uncertainty is a measure of how confident you are in the mea-surement outcome. We endeavor to remedy any known inaccuracies wherever feasible by applying adjustments from calibration certifications. On the other hand, any inaccuracy whose value is unknown is a cause of doubt.(Clin. Lab. 2023;69:xx-xx. DOI: 10.7754/Clin.Lab.2022.220846)