| Sumario: | Objectives: In April 2022, Roche informed SCL's Southland Hospital laboratory of the launch of an updated Elecsys FT3 III assay. To ensure that the new assay could be implemented without significantly changing the results obtained, assay validation was required. Methods: Forty-five samples were analysed; 18 were collected from the Royal College of Pathologists of Australasia (RCPA) Quality Assurance program, and 27 were retrospectively collected from past patient samples. The samples were analysed on the Cobas Pro e801 analyser, first using the reference assay and then analysed again using the updated assay. The two sets of results were compared and analysed using XLSTAT and Analyse-It software to measure the degree of method agreement and the presence of any significant differences between the assays. RCPA Analytical Performance Specifications were used to determine whether the difference between the assays was considered significant. Results: Analysis revealed that the results obtained from the new FT3 assay did not vary significantly from the results from the reference FT3 assay. Passing-Bablok analysis revealed no systemic bias and small levels of proportional bias. The Bland Altman graph identified that, on average, the reference assay produced FT3 results that are 0.151 pmol/L higher than the new assay. The difference between the results from the new FT3 assay compared to the reference assay were below the limits set by the RCPA Analytical Performance Specifications, meaning the differences were insignificant. Conclusion: This assay validation assures us that when SCL's Southland Hospital laboratory starts using the updated Elecsys FT3 III assay, there will be no significant change in the results or how free T3 levels are reported.
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