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First trimester of pregnancy TSH laboratory specific reference intervals established by an indirect method.
María Sanz-Felisi1, Ariadna Arbiol-Roca1, Paula Sánchez-García2
1Clinical Laboratory, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.
Biochemia Medica
|December 16, 2025
Summary
New reference intervals (RIs) for thyroid stimulating hormone (TSH) in pregnant women were established using an indirect method. This approach helps improve the accuracy of thyroid function tests during pregnancy.
Area of Science:
- Clinical Chemistry
- Endocrinology
- Reproductive Medicine
Background:
- Accurate thyroid stimulating hormone (TSH) reference intervals (RIs) are crucial for diagnosing thyroid dysfunction in pregnancy.
- Existing TSH RIs may not accurately reflect the physiological changes during pregnancy, potentially leading to misdiagnosis.
Purpose of the Study:
- To establish laboratory and trimester-specific indirect reference intervals (RIs) for thyroid stimulating hormone (TSH).
- To evaluate the utility of an indirect method for establishing and verifying TSH RIs in pregnant women.
Main Methods:
- A retrospective observational study analyzed TSH results from 1300 first-trimester pregnant outpatients.
- New RIs were determined using the non-parametric percentile method (2.5th and 97.5th percentiles).
- Verification involved an indirect analysis of 486 TSH results and a direct prospective study of 28 pregnant women.
Main Results:
- Established TSH reference intervals (RIs) of 0.60-4.33 mIU/L for the first trimester.
- Both indirect and direct verification methods met CLSI guideline requirements.
Conclusions:
- The indirect method is effective for establishing and verifying local TSH RIs in first-trimester pregnant women.
- Accurate TSH RIs can reduce the misclassification of pregnant women undergoing thyroid function tests.
