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      Thyroglobulin and thyroglobulin antibody: an updated clinical and laboratory expert consensus

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          Abstract

          Objective

          Thyroglobulin measurement is the cornerstone of modern management of differentiated thyroid cancer, with clinical decisions on treatment and follow-up based on the results of such measurements. However, numerous factors need to be considered regarding measurement with and interpretation of thyroglobulin assay results.

          Design

          The present document provides an integrated update to the 2013 and 2014 separate clinical position papers of our group on these issues.

          Methods

          Issues concerning analytical and clinical aspects of highly-sensitive thyroglobulin measurement will be reviewed and discussed based on an extensive analysis of the available literature.

          Results

          Thyroglobulin measurement remains a highly complex process with many pitfalls and major sources of interference, especially anti-thyroglobulin antibodies, need to be assessed, considered and, when necessary, dealt with appropriately.

          Conclusions

          Our expert consensus group formulated 53 practical, graded recommendations for guidance on highly-sensitive thyroglobulin and TgAb in laboratory and clinical practice, especially valuable where current guidelines do not offer sufficient guidance.

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          Most cited references132

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          2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer.

          Thyroid nodules are a common clinical problem, and differentiated thyroid cancer is becoming increasingly prevalent. Since the American Thyroid Association's (ATA's) guidelines for the management of these disorders were revised in 2009, significant scientific advances have occurred in the field. The aim of these guidelines is to inform clinicians, patients, researchers, and health policy makers on published evidence relating to the diagnosis and management of thyroid nodules and differentiated thyroid cancer.
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            Limit of blank, limit of detection and limit of quantitation.

            * Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) are terms used to describe the smallest concentration of a measurand that can be reliably measured by an analytical procedure. * LoB is the highest apparent analyte concentration expected to be found when replicates of a blank sample containing no analyte are tested. LoB = mean(blank) + 1.645(SD(blank)). * LoD is the lowest analyte concentration likely to be reliably distinguished from the LoB and at which detection is feasible. LoD is determined by utilising both the measured LoB and test replicates of a sample known to contain a low concentration of analyte. * LoD = LoB + 1.645(SD (low concentration sample)). * LoQ is the lowest concentration at which the analyte can not only be reliably detected but at which some predefined goals for bias and imprecision are met. The LoQ may be equivalent to the LoD or it could be at a much higher concentration.
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              Laboratory medicine practice guidelines. Laboratory support for the diagnosis and monitoring of thyroid disease.

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                Author and article information

                Contributors
                (View ORCID Profile)
                Journal
                European Journal of Endocrinology
                Oxford University Press (OUP)
                0804-4643
                1479-683X
                August 2023
                August 02 2023
                August 2023
                August 02 2023
                August 25 2023
                : 189
                : 2
                : R11-R27
                Article
                10.1093/ejendo/lvad109
                37625447
                3dd99dce-fc15-46c2-91ac-a29ec0686320
                © 2023

                https://creativecommons.org/licenses/by-nc/4.0/

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