Percentile transformation and recalibration functions allow harmonization of thyroid-stimulating hormone (TSH) immunoassay results

AbstractBackgroundThe comparability of thyroid-stimulating hormone (TSH) results cannot be easily obtained using SI-traceable reference measurement procedures (RPMs) or reference materials, whilst harmonization is more feasible. The aim of this study was to identify and validate a new approach for the harmonization of TSH results.MethodsPercentile normalization was applied to 125,419 TSH results, obtained from seven laboratories using three immunoassays (Access 3rd IS Thyrotropin, Beckman Coulter Diagnostics; Architect System, Abbott Diagnostics and Elecsys, Roche Diagnostics). Recalibration equations (RCAL) were derived by robust regressions using bootstrapped distribution. Two datasets, the first of 119 EQAs, the second of 610, 638 and 639 results from Access, Architect and Elecsys TSH results, respectively, were used to validate RCAL. A dataset of 142,821 TSH values was used to derive reference intervals (RIs) after applying RCAL.ResultsAccess, Abbott and Elecsys TSH distributions were significantly different (p < 0.001). RCAL intercepts and slopes were −0.003 and 0.984 for Access, 0.032 and 1.041 for Architect, −0.031 and 1.003 for Elecsys, respectively. Validation using EQAs showed that before and after RCAL, the coefficients of variation (CVs) or among-assay results decreased from 10.72% to 8.16%. The second validation dataset was used to test RCALs. The median of between-assay differences ranged from −0.0053 to 0.1955 mIU/L of TSH. Elecsys recalibrated to Access (and vice-versa) showed non-significant difference. TSH RI after RCAL resulted in 0.37–5.11 mIU/L overall, 0.49–4.96 mIU/L for females and 0.40–4.92 mIU/L for males. A significant difference across age classes was identified.ConclusionsPercentile normalization and robust regression are valuable tools for deriving RCALs and harmonizing TSH values.

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Comparison of the Incidence of Postoperative Hypothyroidism in Patients Undergoing Conventional Thyroid Lobectomy and Pyramid- and Isthmus-Preserving Lobectomy

International Journal of Endocrinology ◽

10.1155/2021/8162307 ◽

2021 ◽

Vol 2021 ◽

pp. 1-7

Author(s):

Min Jeong Cho ◽

Hyeong Won Yu ◽

Woochul Kim ◽

Yeo Koon Kim ◽

Sang Il Choi ◽

...

Keyword(s):

Thyroid Stimulating Hormone ◽

Thyroid Lobectomy ◽

Significant Difference ◽

Before And After ◽

Pyramidal Lobe ◽

Stimulating Hormone

Hypothyroidism is a recognized sequela of conventional thyroid lobectomy. However, there have been no studies on the incidence of hypothyroidism following the preservation of the isthmus and pyramid during lobectomy. Therefore, in the present study, we compared the incidence of hypothyroidism following conventional lobectomy and lobectomy during which the isthmus and pyramidal lobe were preserved. Data for a total of 65 patients collected between September 2018 and April 2019 were reviewed retrospectively. Circulating thyroid-stimulating hormone (TSH) concentration was measured before and after surgery in a group who underwent conventional thyroid lobectomy (n = 29) and in a group in which the isthmus and pyramid were preserved (n = 36). We found no significant difference in TSH concentration between the two groups before surgery, or 3 months or 1 year after surgery. Thus, there might be no difference in the incidence of postoperative hypothyroidism between patients who undergo conventional thyroid lobectomy and those in which the isthmus and pyramid are preserved.

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Biological variation of total thyroxine (T4), free T4 and thyroid-stimulating hormone in 11 clinically healthy cats

Journal of Feline Medicine and Surgery ◽

10.1177/1098612x20969485 ◽

2020 ◽

pp. 1098612X2096948

Author(s):

Anne Jordan ◽

Rachael Gray ◽

Michael Terkildsen ◽

Mark Krockenberger

Keyword(s):

Population Based ◽

Reference Intervals ◽

Thyroid Stimulating Hormone ◽

Biological Variation ◽

Free T4 ◽

Coefficients Of Variation ◽

Serum T4 ◽

Total Thyroxine ◽

Index Of Individuality ◽

Stimulating Hormone

Objectives The aim of this study was to investigate the biological variation of total thyroxine (T4), free T4 (fT4) and thyroid-stimulating hormone (TSH) in 11 clinically healthy cats aged between 3 and 15 years old, in Sydney, Australia. Methods Blood was collected weekly for up to 6 weeks and serum T4, fT4 and TSH concentrations were analysed using canine-specific reagents. Restricted maximum likelihood was used to estimate within-subject, between-subject and analytical variance components, which were recorded in terms of the related coefficients of variation. The index of individuality and reference change values were then calculated for each analyte. Results T4 and TSH had intermediate individuality, indicating both subject-based and population-based reference intervals (RIs) could be used, with the knowledge that population-based RIs are suboptimally sensitive. fT4 had high individuality, indicating subject-based RIs are more appropriate than population-based RIs. Conclusions and relevance This study has demonstrated that subject-based RIs could be more sensitive than population-based RIs for the diagnosis of thyroid dysfunction in cats.

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Reference intervals for thyroid-stimulating hormone (TSH) and free thyroxine (FT4) in infants’ day 14–30 of life and a comparison with other studies

Journal of Pediatric Endocrinology and Metabolism ◽

10.1515/jpem-2020-0148 ◽

2020 ◽

Vol 33 (9) ◽

pp. 1125-1132

Author(s):

Jeanne Sze Lyn Wong ◽

Nalini M. Selveindran ◽

Rashdan Zaki Mohamed ◽

Fuziah M. Zain ◽

Siti S. Anas ◽

...

Keyword(s):

Thyroid Function ◽

Small Sample Size ◽

Age Groups ◽

Reference Intervals ◽

Thyroid Stimulating Hormone ◽

Small Sample ◽

Free Thyroxine ◽

Significant Difference ◽

Stimulating Hormone

AbstractObjectivesEstablished reference intervals of thyroid function in neonates are important; however, studies often consist of a small sample size or lack of clinical information. We aim to define reference intervals for thyroid-stimulating hormone (TSH) and free thyroxine (FT4) for infants aged 14–30 days. We also reviewed follow-up TSH for infants with initial values 10–20 mIU/L.MethodsVenous TSH and FT4 of term babies aged 14–30 days with breast milk jaundice that had thyroid function test performed as part of a prolonged jaundice workout from September 2016 to March 2017 were analyzed. Electronic medical records were reviewed to ensure only well babies with no pathological causes of jaundice or conditions that may affect thyroid function were included. TSH and FT4 were analyzed using immunoassay analyzer Dxl 800, Beckman Coulter.ResultsThere were no correlations between FT4 and TSH with gender, birth weight and ethnicity. Correlation coefficient between FT4 and total bilirubin was weak at 0.138 (p=0.001). No association was found between TSH and bilirubin levels. Mean FT4 was higher in the younger age group day 14–21 (p<0.01). There was no significant difference in TSH values between the age groups. Infants with mildly elevated TSH 10–20 mIU/L had normalized values on follow-up (mean, 11.41 vs. 4.42 mIU/L; p<0.01; 95%CI, 5.88–8.09). The following reference intervals (2.5–97.5th percentile) were derived: FT4 day 14–21 (n=513): 11.59–21.00 pmoL/L; FT4 day 22–30 (n=66): 10.14–19.60 pmoL/L; TSH day 14–30 (n=579): 1.90–10.34 mIU/L. Comparison between studies showed variations of reference intervals with different manufacturer assays, age and methodology.ConclusionsOur reference intervals would be useful in the clinical setting. Infants with mildly elevated TSH could be monitored first instead of immediate treatment.

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Establishment of Early Pregnancy Related Thyroid Hormone Models and Reference Intervals for Pregnant Women in China Based on Real World Data

Hormone and Metabolic Research ◽

10.1055/a-1402-0290 ◽

2021 ◽

Vol 53 (04) ◽

pp. 272-279

Author(s):

Chaochao Ma ◽

Xiaoqi Li ◽

Lixin Liu ◽

Xinqi Cheng ◽

Fang Xue ◽

...

Keyword(s):

Thyroid Hormone ◽

Thyroid Hormones ◽

Pregnant Women ◽

Early Pregnancy ◽

Gestational Age ◽

Dynamic Change ◽

Reference Intervals ◽

Thyroid Stimulating Hormone ◽

Free Thyroxine ◽

Stimulating Hormone

AbstractThyroid hormone reference intervals are crucial for diagnosing and monitoring thyroid dysfunction during early pregnancy, and the dynamic change trend of thyroid hormones during pregnancy can assist clinicians to assess the thyroid function of pregnant women. This study aims to establish early pregnancy related thyroid hormones models and reference intervals for pregnant women. We established two derived databases: derived database* and derived database#. Reference individuals in database* were used to establish gestational age-specific reference intervals for thyroid hormones and early pregnancy related thyroid hormones models for pregnant women. Individuals in database# were apparently healthy non-pregnant women. The thyroid hormones levels of individuals in database# were compared with that of individuals in database* using nonparametric methods and the comparative confidence interval method. The differences in thyroid stimulating hormone and free thyroxine between early pregnant and non-pregnant women were statistically significant (p<0.0001). The reference intervals of thyroid stimulating hormone, free thyroxine and free triiodothyronine for early pregnant women were 0.052–3.393 μIU/ml, 1.01–1.54 ng/dl, and 2.51–3.66 pg/ml, respectively. Results concerning thyroid stimulating hormone and free thyroxine reference intervals of early pregnancy are comparable with those from other studies using the same detection platform. Early pregnancy related thyroid hormones models showed various change patterns with gestational age for thyroid hormones. Early pregnancy related thyroid hormones models and reference intervals for pregnant women were established, so as to provide accurate and reliable reference basis for the diagnosing and monitoring of maternal thyroid disfunction in early pregnancy.

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Method specific second-trimester reference intervals for thyroid-stimulating hormone and free thyroxine

Clinical Biochemistry ◽

10.1016/j.clinbiochem.2008.12.004 ◽

2009 ◽

Vol 42 (7-8) ◽

pp. 750-753 ◽

Cited By ~ 16

Author(s):

Rechelle Silvio ◽

Karly J. Swapp ◽

Sonia L. La'ulu ◽

Kara Hansen-Suchy ◽

William L. Roberts

Keyword(s):

Reference Intervals ◽

Thyroid Stimulating Hormone ◽

Free Thyroxine ◽

Second Trimester ◽

Stimulating Hormone

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Preterm to term infant postmenstrual age reference intervals for thyroid-stimulating hormone and free thyroxine

Pediatric Research ◽

10.1038/s41390-021-01838-3 ◽

2021 ◽

Author(s):

George M. Ziegler ◽

Jonathan L. Slaughter ◽

Monika Chaudhari ◽

Herveen Singh ◽

Pablo J. Sánchez ◽

...

Keyword(s):

Reference Intervals ◽

Thyroid Stimulating Hormone ◽

Term Infant ◽

Free Thyroxine ◽

Postmenstrual Age ◽

Stimulating Hormone

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Reference intervals for follicle-stimulating hormone, luteinizing hormone and prolactin in children and young adults on the bioMérieux Mini-Vidas system

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm.2007.086 ◽

2007 ◽

Vol 45 (4) ◽

Cited By ~ 6

Author(s):

Thu Koskas ◽

Karamo Souaré ◽

Tarik Ouahabi ◽

Dominique Porquet ◽

Didier Chevenne

Keyword(s):

Luteinizing Hormone ◽

Pediatric Population ◽

Follicle Stimulating Hormone ◽

Reference Intervals ◽

Age Group ◽

Pubertal Stage ◽

Significant Difference ◽

Class 1 ◽

Children And Young Adults ◽

Stimulating Hormone

AbstractWe measured serum follicle-stimulating hormone (FSH), luteinizing hormone (LH) and prolactin concentrations on a bioMérieux Mini Vidas system in a pediatric population ranging in age from 1 to 19 years. Reference intervals were established separately for females and males, with stratification by age group and by Tanner's pubertal stage. FSH values were higher in females than in males, and were lowest in both sexes of age class 2 (4–8 years), increasing thereafter to the upper limit for stage PIV (females) and stage PV (males). LH values showed a similar pattern of change: concentrations were lowest for class 1 (1–3 years) and class 2 (4–8 years), and highest for stage PII (females) and stage PV (males). No significant difference was observed according to gender. Prolactin values did not differ markedly according to gender or pubertal status.Clin Chem Lab Med 2007;45:541–5.

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