Estimation of TSH reference intervals for the first trimester of pregnancy using real world data and the refineR algorithm.

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Title: Estimation of TSH reference intervals for the first trimester of pregnancy using real world data and the refineR algorithm.
Authors: Madurga, Alicia1 (AUTHOR) amadurga@bellvitgehospital.cat, Sanz-Felisi, María1 (AUTHOR), Arbiol-Roca, Ariadna1 (AUTHOR), Sánchez-García, Paula2 (AUTHOR)
Source: Clinica Chimica Acta. Jan2026, Vol. 579, pN.PAG-N.PAG. 1p.
Subjects: First trimester of pregnancy, Reference values, Pregnancy, Empirical research, Thyrotropin
Abstract: Introduction: Changes in the population and differences in pregnant women, as well as trimester-specific reference intervals (RIs), improve the interpretation of thyroid stimulation hormone (TSH). This study seeks to establish first trimester TSH RIs using the indirect method refineR algorithm. Subjects and methods: A retrospective observational study was conducted at a Spanish laboratory's hospital during three years (February 2022 to March 2025). TSH results from 4717 outpatient women in their first trimester of gestation were extracted from the LIS. Most patients were of Caucasian ethnicity. After applying the exclusion criteria (positive thyroid antibodies; abnormal free thyroxine; reported free triiodothyronine; thyroid related diagnosis or follow-up thyroid tests), 4185 TSH results were included in the final dataset. Data management and statistical analyses were conducted using the refineR algorithm and Phyton. The RIs were verified with another dataset, which analysed 697 TSH results extracted during April and June 2025. Finally, the RIs were also verified with a direct prospective study including 24 pregnant women from a health care primary center. All analytes were measured using the electrochemiluminescence immunoassay analyser Cobas® 8000 (Roche, Basel, Switzerland). Results: The TSH RIs obtained for first trimester pregnant women, with 90 % CIs, were: 0.46 (CI 0.37–0.55) – 4.91 (CI 4.09–5.62) mIU/L. Conclusion: This is the first study to establish RIs for TSH in the first trimester of pregnancy using the refineR methodology. • The reference intervals for TSH during the first trimester of pregancy were (0.46–4.91 mIU/L). • This work has been performed using real world data and the refineR algorithm. • This works describes ethnicity, age, gestational weeks, and time of measurement. [ABSTRACT FROM AUTHOR]
Copyright of Clinica Chimica Acta is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Estimation of TSH reference intervals for the first trimester of pregnancy using real world data and the refineR algorithm.
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  Data: <searchLink fieldCode="AR" term="%22Madurga%2C+Alicia%22">Madurga, Alicia</searchLink><relatesTo>1</relatesTo> (AUTHOR)<i> amadurga@bellvitgehospital.cat</i><br /><searchLink fieldCode="AR" term="%22Sanz-Felisi%2C+María%22">Sanz-Felisi, María</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Arbiol-Roca%2C+Ariadna%22">Arbiol-Roca, Ariadna</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Sánchez-García%2C+Paula%22">Sánchez-García, Paula</searchLink><relatesTo>2</relatesTo> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22Clinica+Chimica+Acta%22">Clinica Chimica Acta</searchLink>. Jan2026, Vol. 579, pN.PAG-N.PAG. 1p.
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  Data: <searchLink fieldCode="DE" term="%22First+trimester+of+pregnancy%22">First trimester of pregnancy</searchLink><br /><searchLink fieldCode="DE" term="%22Reference+values%22">Reference values</searchLink><br /><searchLink fieldCode="DE" term="%22Pregnancy%22">Pregnancy</searchLink><br /><searchLink fieldCode="DE" term="%22Empirical+research%22">Empirical research</searchLink><br /><searchLink fieldCode="DE" term="%22Thyrotropin%22">Thyrotropin</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Introduction: Changes in the population and differences in pregnant women, as well as trimester-specific reference intervals (RIs), improve the interpretation of thyroid stimulation hormone (TSH). This study seeks to establish first trimester TSH RIs using the indirect method refineR algorithm. Subjects and methods: A retrospective observational study was conducted at a Spanish laboratory's hospital during three years (February 2022 to March 2025). TSH results from 4717 outpatient women in their first trimester of gestation were extracted from the LIS. Most patients were of Caucasian ethnicity. After applying the exclusion criteria (positive thyroid antibodies; abnormal free thyroxine; reported free triiodothyronine; thyroid related diagnosis or follow-up thyroid tests), 4185 TSH results were included in the final dataset. Data management and statistical analyses were conducted using the refineR algorithm and Phyton. The RIs were verified with another dataset, which analysed 697 TSH results extracted during April and June 2025. Finally, the RIs were also verified with a direct prospective study including 24 pregnant women from a health care primary center. All analytes were measured using the electrochemiluminescence immunoassay analyser Cobas® 8000 (Roche, Basel, Switzerland). Results: The TSH RIs obtained for first trimester pregnant women, with 90 % CIs, were: 0.46 (CI 0.37–0.55) – 4.91 (CI 4.09–5.62) mIU/L. Conclusion: This is the first study to establish RIs for TSH in the first trimester of pregnancy using the refineR methodology. • The reference intervals for TSH during the first trimester of pregancy were (0.46–4.91 mIU/L). • This work has been performed using real world data and the refineR algorithm. • This works describes ethnicity, age, gestational weeks, and time of measurement. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
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  Group: Ab
  Data: <i>Copyright of Clinica Chimica Acta is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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RecordInfo BibRecord:
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    Identifiers:
      – Type: doi
        Value: 10.1016/j.cca.2025.120689
    Languages:
      – Code: eng
        Text: English
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        StartPage: N.PAG
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      – SubjectFull: First trimester of pregnancy
        Type: general
      – SubjectFull: Reference values
        Type: general
      – SubjectFull: Pregnancy
        Type: general
      – SubjectFull: Empirical research
        Type: general
      – SubjectFull: Thyrotropin
        Type: general
    Titles:
      – TitleFull: Estimation of TSH reference intervals for the first trimester of pregnancy using real world data and the refineR algorithm.
        Type: main
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            NameFull: Madurga, Alicia
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            NameFull: Sanz-Felisi, María
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            NameFull: Arbiol-Roca, Ariadna
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            NameFull: Sánchez-García, Paula
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          Dates:
            – D: 15
              M: 01
              Text: Jan2026
              Type: published
              Y: 2026
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