Establishing Laboratory-Specific Reference Intervals for TSH and fT4 by use of the Indirect Hoffman Method

Abstract

\n Background: The results of examinations of laboratory parameters are the basis of appropriate medical decisions. The availability of reliable and accurate reference intervals (RIs) for each laboratory parameter is an integral part of its appropriate interpretation. Each medical laboratory should confirm their RIs. Up to date reference intervals for thyroid function hormones are still a matter of ongoing controversy. The aim of the study was application of the indirect Hoffman method to determine RIs for TSH and fT4 based on the large data pools stored in laboratory information systems, and the comparison of these RIs to generally used RIs.Material and methods: The TSH and fT4 routine examination results of a hospitalized and outpatients population over five years (2015-2019) were collected, and reference limits were established by the improved Hoffmann method after the exclusion of outliers. Comparative verification of established RIs was conducted with the RIs values provided by test manufacturers and literature data.Results: The various RIs in different age groups in examined populations were observed. For TSH RIs varied between different age groups, with a narrower range of RIs in the studied adult population, while for children, a shift of both reference boundaries toward higher values in comparison to manufacturers data was observed. RIs estimated for fT4 were very similar to the manufacturer and literature data.Conclusion: Thyroid hormone levels change during a person s lifetime and vary between sexes, but this difference does not always influence the clinical interpretation of laboratory results in the context of RIs. The use of indirect methods is justified due to the ease and low cost of their application.