Agreement between routinely used immunoassays for thyroid function testing in non-pregnant and pregnant adults.
T3
T4
TSH
gestation
harmonization
reference intervals
standardization
Journal
Clinical endocrinology
ISSN: 1365-2265
Titre abrégé: Clin Endocrinol (Oxf)
Pays: England
ID NLM: 0346653
Informations de publication
Date de publication:
17 Apr 2024
17 Apr 2024
Historique:
revised:
17
03
2024
received:
21
01
2024
accepted:
10
04
2024
medline:
17
4
2024
pubmed:
17
4
2024
entrez:
17
4
2024
Statut:
aheadofprint
Résumé
Thyroid function tests are common biochemical analyses, and agreement between the routinely used immunoassays is important for diagnosis and monitoring of thyroid disease. Efforts are continuously made to align the biochemical assays, and we aimed to evaluate the agreement between immunoassays used in a clinical laboratory setting among non-pregnant and pregnant adults. Cross-sectional study. Serum samples were obtained from 192 blood donors (non-pregnant adults) and from 86 pregnant women in the North Denmark Region with no known thyroid disease. Each sample was used for measurement of thyroid-stimulating hormone (TSH) with the routinely used automatic immunoassays in the regional Departments of Clinical Biochemistry (Alinity, Abbott Laboratories, Cobas, Roche Diagnostics, and Atellica, Siemens Healthineers) and reported as the median with 95% confidence interval (95% CI). In nonpregnant adults, the level of TSH was higher with Cobas and Atellica than with Alinity as reflected by median (Alinity: 1.39 mIU/L (95% CI: 1.30-1.51 mIU/L); Cobas: 1.57 mIU/L (95% CI: 1.48-1.75 mIU/L); Atellica: 1.74 mIU/L (95% CI: 1.61-1.83 mIU/L)). Similarly, a trend was seen towards higher median TSH with Cobas than with Alinity among pregnant women (Alinity: 1.90 mIU/L (95% CI: 1.37-2.82 mIU/L); Cobas: 2.33 mIU/L (95% CI: 1.69-3.62 mIU/L)). Results of thyroid function tests obtained with different immunoassays were not interchangeable when evaluated among pregnant and non-pregnant adults. The distinct differences are relevant for clinical decision making and emphasize the necessity of clinical laboratory information when different assays are used for diagnosis and monitoring of patients with thyroid disease.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024 The Authors. Clinical Endocrinology published by John Wiley & Sons Ltd.
Références
Van Uytfanghe K, Ehrenkranz J, Halsall D, et al. Thyroid stimulating hormone and thyroid hormones (triiodothyronine and thyroxine): an American Thyroid Association—commissioned review of current clinical and laboratory status. Thyroid. 2023;33:1013‐1028.
Carlé A, Pedersen IB, Knudsen N, Perrild H, Ovesen L, Laurberg P. Hypothyroid symptoms and the likelihood of overt thyroid failure: a population‐based case‐control study. Eur J Endocrinol. 2014;171:593‐602.
Carlé A, Pedersen IB, Knudsen N, et al. Hypothyroid symptoms fail to predict thyroid insufficiency in old people: a population‐based case‐control study. Am J Med. 2016;129:1082‐1092.
Zhelev Z, Abbott R, Rogers M, et al. Effectiveness of interventions to reduce ordering of thyroid function tests: a systematic review. BMJ Open. 2016;6:e010065.
Osinga JAJ, Derakhshan A, Feldt‐Rasmussen U, et al. TSH and FT4 reference interval recommendations and prevalence of gestational thyroid dysfunction: quantification of current diagnostic approaches. J Clin Endocrinol Metab. 2023;109:868‐878.
Önsesveren I, Barjaktarovic M, Chaker L, et al. Childhood thyroid function reference ranges and determinants: a literature overview and a prospective cohort study. Thyroid. 2017;27:1360‐1369.
Vesper HW, Van Uytfanghe K, Hishinuma A, et al. Implementing reference systems for thyroid function tests – a collaborative effort. Clin Chim Acta. 2021;519:183‐186.
Danmarks Statistik. Indvandrere i Danmark 2023. Danmarks Statistik. 2023;1:1‐138.
Laurberg P, Jørgensen T, Perrild H, et al. The Danish investigation on iodine intake and thyroid disease, DanThyr: status and perspectives. Eur J Endocrinol. 2006;155:219‐228.
Knøsgaard L, Andersen S, Hansen AB, Sørensen A, Vestergaard P, Andersen SL. Iodine status in Danish pregnant women after an increase in iodine fortification. Clin Endocrinol. 2022;98:407‐414.
Erikstrup C, Sørensen E, Nielsen KR, et al. Cohort profile: the Danish blood donor study. Int J Epidemiol. 2023;52:e162‐e171.
Andersen SL, Andersen S, Carlé A, et al. Pregnancy week‐specific reference ranges for thyrotropin and free thyroxine in the north Denmark region pregnancy cohort. Thyroid. 2019;29:430‐438.
Lou S, Petersen OB, Jørgensen FS, Lund ICB, Kjærgaard S, Vogel I. National screening guidelines and developments in prenatal diagnoses and live births of Down syndrome in 1973–2016 in Denmark. Acta Obstet Gynecol Scand. 2018;97:195‐203.
Andersen SL, Christensen PA, Knøsgaard L, et al. Classification of thyroid dysfunction in pregnant women differs by analytical method and type of thyroid function test. J Clin Endocrinol Metab. 2020;105:e4012‐e4022.
Andersen SL, Bruun NH, Christensen PA, et al. Cut‐offs for thyroid peroxidase and thyroglobulin antibodies in early pregnancy. Eur Thyroid J. 2022;11:e220142.
Gardner MJ, Altman DG. Confidence intervals rather than P values: estimation rather than hypothesis testing. BMJ. 1986;292:746‐750.
Bilić‐Zulle L. Comparison of methods: Passing and Bablok regression. Biochem Medica. 2011;21:49‐52.
Horowitz GL, Altaie S, Boyd JC, et al. EP28‐A3C defining, establishing, and verifying reference intervals in the clinical laboratory; Approved Guideline. Third Edition. Clin Lab Stand Inst. 2010;28:1‐61.
WHO, UNICEF, ICCIDD. Assessment of Iodine Deficiency Disorders and Monitoring their Elimination. A Guide for Programme Managers. Vol 3. World Health Organization; 2007:1‐98.
De Leo S, Lee SY, Braverman LE. Hyperthyroidism. Lancet. 2016;388:906‐918.
Chaker L, Bianco AC, Jonklaas J, Peeters RP. Hypothyroidism. Lancet. 2017;390:1550‐1562.
Laurberg P, Pedersen IB, Carle A, et al. The U‐shaped curve of iodine intake and thyroid disorders. In: Preedy VR, Burrow GN, Watson RR, eds. Comprehensive Handbook of Iodine: Nutritional, Biochemical, Pathological and Therapeutic Aspects. 1st ed. Academic Press/Elsevier; 2009:449‐455.
Petersen M, Pedersen IB, Carlé A, et al. Iodine fortification has reduced overt thyrotxcosis incidence in Denmark with 40%. A 16 year prospective populationn study. Eur Thyroid J. 2016;5:84.
Petersen M, Knudsen N, Carlé A, et al. Increased incidence rate of hypothyroidism after iodine fortification in Denmark: a 20‐year prospective population‐based study. J Clin Endocrinol Metab. 2019;104:1833‐1840.
Thienpont LM, Van Uytfanghe K, De Grande LAC, et al. Harmonization of serum thyroid‐stimulating hormone measurements paves the way for the adoption of a more uniform reference interval. Clin Chem. 2017;63:1248‐1260.
Ursem SR, Boelen A, Hillebrand JJ, den Elzen WPJ, Heijboer AC. How low can we (reliably) go? A method comparison of thyroid‐stimulating hormone assays with a focus on low concentrations. Eur Thyroid J. 2023;12:e230123.
Lee RH, Spencer CA, Mestman JH, et al. Free T4 immunoassays are flawed during pregnancy. Am J Obstet Gynecol. 2009;200:260.e1‐260.e6.
Jansen HI, van Herwaarden AE, Huijgen HJ, et al. Pregnancy disrupts the accuracy of automated fT4 immunoassays. Eur Thyroid J, 2022; 11(6):220145.
Hickman PE, Koerbin G, Simpson A, et al. Using a thyroid disease‐free population to define the reference interval for TSH and free T4 on the Abbott Architect analyser. Clin Endocrinol. 2017;86:108‐112.
McNeil AR, Stanford PE. Reporting thyroid function tests in pregnancy. Clin Biochem Rev. 2015;36:109‐126.
Männistö T, Surcel M, Bloigu A, et al. The effect of freezing, thawing, and short‐ and long‐term storage on serum thyrotropin, thyroid hormones, and thyroid autoantibodies: implications for analyzing samples stored in serum banks. Clin Chem. 2007;53:1986‐1987.
Mannisto T, Suvanto E, Surcel HM, Ruokonen A. Thyroid hormones are stable even during prolonged frozen storage. Clin Chem Lab Med. 2010;48:1662‐1669.
Bauer Westbye A, Aas FE, Dahl SR, et al. Large method differences for free thyroid hormone assays in the hyperthyroid range can affect assessment of hyperthyroid status: comparison of Abbott Alinity to Roche Cobas, Siemens Centaur and equilibrium dialysis LC‐MS/MS. Clin Biochem. 2023;121‐122:110676.
Okosieme OE, Agrawal M, Usman D, Evans C. Method‐dependent variation in TSH and FT4 reference intervals in pregnancy: a systematic review. Ann Clin Biochem: Int J Lab Med. 2021;58(5):537‐546.
Barth JH, Luvai A, Jassam N, et al. Comparison of method‐related reference intervals for thyroid hormones: studies from a prospective reference population and a literature review. Ann Clin Biochem: Int J Lab Med. 2018;55:107‐112.
Kalaria T, Sanders A, Fenn J, et al. The diagnosis and management of subclinical hypothyroidism is assay‐dependent–implications for clinical practice. Clin Endocrinol. 2021;94:1012‐1016.
Sørensen CJ, Pedersen OB, Petersen MS, et al. Combined oral contraception and obesity are strong predictors of low‐grade inflammation in healthy individuals: results from the Danish Blood Donor Study (DBDS). PLoS One. 2014;9:e88186.
Effraimidis G, Wiersinga WM. Mechanisms in endocrinology: autoimmune thyroid disease: old and new players. Eur J Endocrinol. 2014;170:R241‐R252.
Wiegratz I, Kutschera E, Lee JH, et al. Effect of four different oral contraceptives on various sex hormones and serum‐binding globulins. Contraception. 2003;67:25‐32.
Vadiveloo T, Donnan PT, Murphy MJ, Leese GP. Age‐ and gender‐specific TSH reference intervals in people with no obvious thyroid disease in tayside, Scotland: the thyroid epidemiology, audit, and research study (TEARS). J Clin Endocrinol Metab. 2013;98:1147‐1153.