B-020 Study of Method Intercomparison between Atellica Solution® and CI® Analyzers for T4L, β-HCG Total, and PSA Total

Abstract

Background Method intercomparison is an essential requirement in Clinical Laboratories before changing a method or instrument to verify the interchangeability of results. After validating a new Siemens device, the CI®, we conducted an intercomparison study with the Atellica Solution® for T4 free (T4L), β-HCG total, and PSA total assays. Objectives To check the interchangeability of results between the methods of T4L, β-HCG total, and PSA total, as determined on the Atellica Solution® and CI® analyzers, to evaluate the behavior of both equipment in our laboratory as a single virtual team. Methods A total of 120 serum samples from patients with T4L values between 0.41 and 7.5 ng/dL, β-HCG total between 0.5 and 1000 mIU/mL, and PSA total between 0.01 and 78.4 ng/mL were processed on both analyzers. Passing-Bablok regression, Bland-Altman analysis, and Pearson correlation coefficient were used to evaluate the sample size. Results are expressed with a 95% confidence interval. The intercomparison study was conducted using Method Validator Version 1.19. Results See table Conclusions After evaluating the results, we conclude that the Atellica Solution® and CI® analyzers behave as a single virtual team for the T4L, β-HCG total, and PSA total assays. Although there are systematic errors, they do not exceed the quality specifications established in our laboratory, based on the Total Error allowable according to Biological Variability.