scholarly journals Comparison of method-related reference intervals for thyroid hormones: studies from a prospective reference population and a literature review

Author(s):  
Julian H Barth ◽  
Ahai Luvai ◽  
Nuthar Jassam ◽  
Wycliffe Mbagaya ◽  
Eric S Kilpatrick ◽  
...  

Introduction Reference intervals are dependent on the reference population, the analytical methods and the way the data are handled statistically. Individual method-related differences have been studied but the comparative differences in reference intervals have not. Methods We studied a reference population of healthy adult subjects and measured free thyroxine and thyroid-stimulating hormone by the four most commonly used analytical platforms used in the UK. Subjects were excluded if they were > 65 years or had positive thyroid peroxidase antibodies. We also performed a systematic literature review of thyroid hormone reference interval studies in non-pregnant adults. Results In total, 303 subjects were recruited and 42 excluded. The central 95th centile values for thyroid-stimulating hormone (mIU/L) were Abbott Architect (0.51–3.67); Beckman Unicel DxI (0.57–3.60); Roche Cobas (0.60–4.31) and Siemens Advia Centaur XP (0.63–4.29). The 95th centile values for thyroxine (pmol/L) were Abbott Architect (10.6–15.5); Beckman Unicel DxI (7.9–13.0); Roche Cobas (12.5–19.6) and Siemens Advia Centaur XP (11.8–19.0). We identified 55 papers describing thyroid reference intervals in male and non-pregnant female adults. The values for upper and lower reference intervals by manufacturer varied but were not significantly different for thyroid-stimulating hormone but were for thyroxine. Discussion Our study demonstrates clearly that there are marked variations in the reference intervals for thyroid hormones between analytical platforms. There is an urgent need for standardization of thyroid hormone assays to permit transferability of results. Until then, guidelines will need to reflect this method-related difference.

2021 ◽  
Vol 53 (04) ◽  
pp. 272-279
Author(s):  
Chaochao Ma ◽  
Xiaoqi Li ◽  
Lixin Liu ◽  
Xinqi Cheng ◽  
Fang Xue ◽  
...  

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.


2017 ◽  
Vol 21 (1) ◽  
pp. 17-21
Author(s):  
Nandita Hazra ◽  
Binay Mitra ◽  
Reetika Pal

ABSTRACT Aim Maternal thyroid hormone levels during pregnancy are vital for the health of the mother as well as the developing child. Fetal growth is affected by maternal thyroid levels. Various physiological changes like alterations of thyroxine-binding globulins, human chorionic gonadotropin level, and changes in iodide metabolism affect maternal thyroid hormone levels. Therefore, reference intervals (RIs) for thyroid hormones in pregnant population require to be established separately from the general population. Materials and methods The RIs of serum triiodothyronine (T3), thyroxine (T4), and thyroid-stimulating hormone (TSH) were determined in healthy pregnant women by enzyme-linked immunosorbent assay (ELISA) technique after segregating them into three trimesters. This study was conducted in a 492-bedded zonal-level hospital. The reference population was chosen from a study population of pregnant women by strict inclusion and exclusion criteria. The assays were done by the most-commonly used, economical ELISA method employing standard kits. Tests were done using accurate and precise methods with proper quality control measures. Results The RIs were calculated from the central 95% of distribution of total T3, total T4, and TSH values located between 2.5 and 97.5 percentile values. The 0.90 confidence intervals for the upper and lower reference limits were calculated. The values thus obtained were different from those provided by the manufacturer kit literature. Conclusion It is recommended to determine one's own laboratory-specific, method-specific, trimester-wise RIs for maternal thyroid hormone status and use them for screening of pregnant women. How to cite this article Chakrabarty BK, Mitra B, Pal R, Hazra N. Specific Reference Intervals of Serum Triiodothyronine, Thyroxine, and Thyroid-stimulating Hormone in Normal Pregnant Indian Women as per Trimester. Indian J Med Biochem 2017;21(1):17-21.


2012 ◽  
Vol 63 (3) ◽  
pp. 255-262 ◽  
Author(s):  
Marijana Ćurčić ◽  
Saša Janković ◽  
Vesna Jaćević ◽  
Sanja Stanković ◽  
Slavica Vučinić ◽  
...  

The aim of this study was to see how a mixture of cadmium (Cd) and decabrominated diphenyl ether (BDE209) affect thyroid function, namely thyroid-stimulating hormone (TSH), thyroxin (T4), free thyroxin (FT4), triiodothyronin (T3), and free triiodothyronin (FT3) in Wistar rats (eight per group) receiving either a single substance or their combination by gavage for 28 days. Three groups were receiving Cd alone in the doses of 2.5 mg kg-1, 7.5 mg kg-1, or 15 mg kg-1 b. w. a day, three groups were receiving BDE209 in the doses of 1000 mg kg-1, 2000 mg kg-1, or 4000 mg kg-1 b. w. a day, while nine groups were receiving different mixtures of Cd and BDE209 in these doses (3x3 design). The results have indicated that the Cd+BDE209 mixtures more potently disrupt thyroid hormone homeostasis than would be expected from these chemicals alone.


2010 ◽  
Vol 411 (3-4) ◽  
pp. 250-252 ◽  
Author(s):  
Steven J Soldin ◽  
Luke L Cheng ◽  
Lisa Y Lam ◽  
Alice Werner ◽  
Alexander D Le ◽  
...  

2021 ◽  
Vol 68 (2) ◽  
pp. 488-493
Author(s):  
Adrijana Oblak ◽  
Ajda Biček ◽  
Edvard Pirnat ◽  
Katja Zaletel ◽  
Simona Gaberšček

For thyroid function estimation and clinical decision making, use of appropriate reference intervals for thyroid-stimulating hormone (TSH), free thyroxine (fT4) and free triiodothyronine (fT3) is crucial. For each laboratory, establishment of own reference intervals is advised. For the first Slovenian estimation of reference intervals for thyroid hormones a large group of 1722 healthy individuals without thyroid disease was established retrospectively. Hormone analyses were performed on automated analyser Advia Centaur XP Immunoassay System (Siemens Healthineers), which reference intervals for TSH, fT4 and fT3 were 0.55–4.78 mIU/L, 11.5–22.7 pmol/L, and 3.5–6.5 pmol/L, respectively. Statistical analysis followed non-parametric percentile method. Our laboratory reference intervals for TSH, fT4 and fT3 are mostly narrower than intervals given by manufacturer. Median value, lower and upper limit for TSH, fT4 and fT3 were 1.98 (0.59–4.23) mIU/L, 14.5 (11.3–18.8) pmol/L and 4.82 (3.79–6.05) pmol/L, respectively. Most likely, an inclusion of a high number of healthy individuals without thyroid disease was a reason for such results.


2020 ◽  
Vol 34 (5) ◽  
Author(s):  
Zhen‐Zhen Li ◽  
Ben‐Zhang Yu ◽  
Ji‐Liang Wang ◽  
Qin Yang ◽  
Jia Ming ◽  
...  

2017 ◽  
Vol 21 (2) ◽  
pp. 96-100
Author(s):  
Nandita Hazra ◽  
Binay Mitra ◽  
Reetika Pal

ABSTRACT Aim Maternal thyroid hormone level during pregnancy is a vital parameter for the health of mother as well as developing child. Fetal growth is affected by maternal thyroid levels. Various physiological changes like alterations of thyroxine binding globulins (TBGs), beta-human chorionic gonadotropin (β-hCG) level, and change of iodide metabolism affect maternal thyroid hormone levels. Therefore, reference intervals (RI) for thyroid hormones in pregnant population require to be established separately from general population. Materials and methods The RIs of serum triiodothyronine (T3), thyroxine (T4), and thyroid-stimulating hormone (TSH) were determined in healthy pregnant women by enzyme-linked immunosorbent assay (ELISA) technique after segregating them into three trimesters. This study was conducted in a 492-bedded zonal level hospital. The reference population was chosen from a study population of pregnant women by strict inclusion and exclusion criteria. The assays were done by the most commonly used economical ELISA method using standard kits. Tests were done using accurate and precise methods with proper quality control measures. Results The RIs were calculated from the central 95% of distribution of total T3, total T4, and TSH values located between 2.5 and 97.5 percentile values. The 0.90 confidence intervals (CIs) for the upper and lower reference limits were calculated. The values thus obtained were different from those provided by manufacturer kit literature. Conclusion It is recommended to determine own laboratory-specific, method-specific, trimester-wise RI for maternal thyroid hormone status and use them for screening of pregnant mothers. How to cite this article Chakrabarty BK, Mitra B, Pal R, Hazra N. Specific Reference Intervals of Serum Triiodothyronine, Thyroxine, and Thyroid-stimulating Hormone in Normal Pregnant Indian Women as per Trimester. Indian J Med Biochem 2017;21(2):96-100.


2014 ◽  
Vol 11 (1) ◽  
pp. 18-21 ◽  
Author(s):  
O Nepal ◽  
BR Pokharel ◽  
K Khanal ◽  
P Gyawali ◽  
SL Malik ◽  
...  

Background The endocrine changes related to altitude adaptation in human have attracted physiologists around the globe for long. A number of high altitude studies to detect the physiological changes have been performed now and then. But, the study to see the hormonal changes to compare populations residing at different high altitudes is a scarce. Hence, we have performed a study in native populations of different high altitude comparing changes in thyroid hormones in western Nepal. The Jharkot population included in this study is at altitude of 3760m and Jomsom population at 2800m height from sea bed. Objective The study is to compare changes in thyroid hormones at two different high altitude natives. Methods To compare thyroid status between high altitude natives at two different altitudes a cross sectional study is performed by random sampling method. The blood sample was collected in a vacutainer from fifty eight individuals after obtaining the informed consent of participants. The blood collected from antecubital vein was centrifuged in an hour and the serum obtained was used for biochemical analysis of free triiodothyronine, free thyroxine and thyroid stimulating hormone. Results Mean free thyroxine (fT4) of Jharkot population is significantly larger (p = 0.001) than Jomsom population. Mean thyroid stimulating hormone (TSH) with p = 0.597, does not indicate the difference between this two population. There is no significant difference between mean free triiodothyronine (fT3) of Jharkot and Jomsom population (p = 0.345). Conclusion The rise in free thyroid hormone at high altitude is not dependent on the thyroid stimulating hormone released from anterior pituitary. The rise in free thyroxine is found at higher altitude and no difference in fT3 level is detected in population studied at high altitudes. DOI: http://dx.doi.org/10.3126/kumj.v11i1.11017 Kathmandu University Medical Journal Vol.11(1) 2013: 18-21


2020 ◽  
Vol 58 (10) ◽  
pp. 1663-1672 ◽  
Author(s):  
Andrea Padoan ◽  
Aldo Clerico ◽  
Martina Zaninotto ◽  
Tommaso Trenti ◽  
Renato Tozzoli ◽  
...  

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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