{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T09:49:56Z","timestamp":1792230596080,"version":"4.4.0"},"reference-count":33,"publisher":"Walter de Gruyter GmbH","issue":"4","funder":[{"DOI":"10.13039\/100000161","name":"National Institute of Standards and Technology","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100000161","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100000063","name":"Office of Dietary Supplements","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100000063","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,3,26]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec id=\"j_cclm-2020-0977_abs_001\"><jats:title>Objectives<\/jats:title><jats:p>Matrix differences among serum samples from non-pregnant and pregnant patients could bias measurements. Standard Reference Material 1949, Frozen Human Prenatal Serum, was developed to provide a quality assurance material for the measurement of hormones and nutritional elements throughout pregnancy.<\/jats:p><\/jats:sec><jats:sec id=\"j_cclm-2020-0977_abs_002\"><jats:title>Methods<\/jats:title><jats:p>Serum from non-pregnant women and women in each trimester were bottled into four levels based on pregnancy status and trimester. Liquid chromatography tandem mass spectrometry (LC-MS\/MS) methods were developed and applied to the measurement of thyroid hormones, vitamin D metabolites, and vitamin D-binding protein (VDBP). Copper, selenium, and zinc measurements were conducted by inductively coupled plasma dynamic reaction cell MS. Thyroid stimulating hormone (TSH), thyroglobulin (Tg), and thyroglobulin antibody concentrations were analyzed using immunoassays and LC-MS\/MS (Tg only).<\/jats:p><\/jats:sec><jats:sec id=\"j_cclm-2020-0977_abs_003\"><jats:title>Results<\/jats:title><jats:p>Certified values for thyroxine and triiodothyronine, reference values for vitamin D metabolites, VDBP, selenium, copper, and zinc, and information values for reverse triiodothyronine, TSH, Tg, and Tg antibodies were assigned. Significant differences in serum concentrations were evident for all analytes across the four levels (p\u22640.003).<\/jats:p><jats:p>TSH measurements were significantly different (p&lt;0.0001) among research-only immunoassays. Tg concentrations were elevated in research-only immunoassays vs. Federal Drug Administration-approved automated immunoassay and LC-MS\/MS. Presence of Tg antibodies increased differences between automated immunoassay and LC-MS\/MS.<\/jats:p><\/jats:sec><jats:sec id=\"j_cclm-2020-0977_abs_004\"><jats:title>Conclusions<\/jats:title><jats:p>The analyte concentrations\u2019 changes consistent with the literature and the demonstration of matrix interferences in immunoassay Tg measurements indicate the functionality of this material by providing a relevant matrix-matched reference material for the different stages of pregnancy.<\/jats:p><\/jats:sec>","DOI":"10.1515\/cclm-2020-0977","type":"journal-article","created":{"date-parts":[[2020,11,3]],"date-time":"2020-11-03T15:06:33Z","timestamp":1604415993000},"page":"671-679","source":"Crossref","is-referenced-by-count":9,"title":["Development of a pregnancy-specific reference material for thyroid biomarkers, vitamin\u00a0D, and nutritional trace elements in serum"],"prefix":"10.1515","volume":"59","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9765-7559","authenticated-orcid":false,"given":"Ashley S. P.","family":"Boggs","sequence":"first","affiliation":[{"name":"National Institute of Standards and Technology , Hollings Marine Laboratory , Charleston , SC , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa E.","family":"Kilpatrick","sequence":"additional","affiliation":[{"name":"National Institute of Standards and Technology , Gaithersburg , MD , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carolyn Q.","family":"Burdette","sequence":"additional","affiliation":[{"name":"National Institute of Standards and Technology , Gaithersburg , MD , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Denise S.","family":"Tevis","sequence":"additional","affiliation":[{"name":"Division of Laboratory Sciences, National Center for Environmental Health , Centers for Disease Control and Prevention , Atlanta , GA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zachary A.","family":"Fultz","sequence":"additional","affiliation":[{"name":"Division of Laboratory Sciences, National Center for Environmental Health , Centers for Disease Control and Prevention , Atlanta , GA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael A.","family":"Nelson","sequence":"additional","affiliation":[{"name":"National Institute of Standards and Technology , Gaithersburg , MD , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffery M.","family":"Jarrett","sequence":"additional","affiliation":[{"name":"Division of Laboratory Sciences, National Center for Environmental Health , Centers for Disease Control and Prevention , Atlanta , GA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer V.","family":"Kemp","sequence":"additional","affiliation":[{"name":"Division of Clinical Biochemistry and Immunology, Department of Laboratory Medicine and Pathology , Mayo Clinic , Rochester , MN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ravinder J.","family":"Singh","sequence":"additional","affiliation":[{"name":"Division of Clinical Biochemistry and Immunology, Department of Laboratory Medicine and Pathology , Mayo Clinic , Rochester , MN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan K. G.","family":"Grebe","sequence":"additional","affiliation":[{"name":"Division of Clinical Biochemistry and Immunology, Department of Laboratory Medicine and Pathology , Mayo Clinic , Rochester , MN , USA"},{"name":"Division of Endocrinology, Department of Medicine, Mayo Clinic , Rochester , MN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen A.","family":"Wise","sequence":"additional","affiliation":[{"name":"National Institute of Standards and Technology , Gaithersburg , MD , USA"},{"name":"National Institutes of Health, Office of Dietary Supplements , Bethesda , MD , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brittany L.","family":"Kassim","sequence":"additional","affiliation":[{"name":"National Institute of Standards and Technology , Hollings Marine Laboratory , Charleston , SC , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen E.","family":"Long","sequence":"additional","affiliation":[{"name":"National Institute of Standards and Technology , Hollings Marine Laboratory , Charleston , SC , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2020,10,26]]},"reference":[{"key":"2022031413522366226_j_cclm-2020-0977_ref_001","doi-asserted-by":"crossref","unstructured":"Weeke, J, Dybkjaer, L, Granlie, K, Eskjaer Jensen, S, Kjaerulff, E, Laurberg, P, et al. A longitudinal study of serum TSH, and total and free iodothyronines during normal pregnancy. Acta Endocrinol 1982;101:531\u20137. https:\/\/doi.org\/10.1530\/acta.0.1010531.","DOI":"10.1530\/acta.0.1010531"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_002","doi-asserted-by":"crossref","unstructured":"American College of Obstetricians and Gynecologists. Practice bulletin no. 148: thyroid disease in pregnancy. Obstet Gynecol 2015;125:996\u20131005. https:\/\/doi.org\/10.1097\/01.AOG.0000462945.27539.93.","DOI":"10.1097\/01.AOG.0000462945.27539.93"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_003","doi-asserted-by":"crossref","unstructured":"Alexander, EK, Pearce, EN, Brent, GA, Brown, RS, Chen, H, Dosiou, C, et\u00a0al. Guidelines of the American thyroid association for the diagnosis and management of thyroid disease during pregnancy and the postpartum. Thyroid 2017;27:315. https:\/\/doi.org\/10.1089\/thy.2016.0457.","DOI":"10.1089\/thy.2016.0457"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_004","doi-asserted-by":"crossref","unstructured":"Jansen, TA, Korevaar, TIM, Mulder, TA, White, T, Muetzel, RL, Peeters, RP, et al. Maternal thyroid function during pregnancy and child brain morphology: a time window-specific analysis of a prospective cohort. Lancet Diabetes Endocrinol 2019;7:629\u201337. https:\/\/doi.org\/10.1016\/s2213-8587(19)30153-6.","DOI":"10.1016\/S2213-8587(19)30153-6"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_005","doi-asserted-by":"crossref","unstructured":"Specker, BL. Does vitamin D during pregnancy impact offspring growth and bone? Proc Nutr Soc 2011;71:38\u201345. https:\/\/doi.org\/10.1017\/s0029665111003053.","DOI":"10.1017\/S0029665111003053"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_006","doi-asserted-by":"crossref","unstructured":"American College of Obstetricians and Gynecologists. Opinion no. 495: vitamin D: screening and supplementation during pregnancy. Obstet Gynecol 2011;118:197\u20138. https:\/\/doi.org\/10.1097\/AOG.0b013e318227f06b.","DOI":"10.1097\/AOG.0b013e318227f06b"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_007","doi-asserted-by":"crossref","unstructured":"Bedwal, RS, Bahuguna, A. Zinc, copper and selenium in reproduction. Experientia 1994;50:626\u201340. https:\/\/doi.org\/10.1007\/bf01952862.","DOI":"10.1007\/BF01952862"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_008","unstructured":"Joseph, JC, Baker, C, Sprang, ML, Bermes, EW. Changes in plasma proteins during pregnancy. Ann Clin Lab Sci 1978;8:130\u201341. http:\/\/www.annclinlabsci.org\/content\/8\/2\/130.full.pdf."},{"key":"2022031413522366226_j_cclm-2020-0977_ref_009","doi-asserted-by":"crossref","unstructured":"Ward, CD, Williams, RJ, Mullenix, K, Syhapanha, K, Jones, RL, Caldwell, K. Trace metals screening process of devices used for the collection, analysis, and storage of biological specimens. At Spectrosc 2018;39:219\u201328. https:\/\/doi.org\/10.46770\/as.2018.06.001.","DOI":"10.46770\/AS.2018.06.001"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_010","doi-asserted-by":"crossref","unstructured":"Nelson, MA, Waters, JF, Toman, B, Lang, BE, R\u00fcck, A, Breitruck, K, et al. A new realization of SI for organic chemical measurement: NIST PS1 primary standard for quantitative NMR (benzoic acid). Anal Chem 2018;90:10510\u20137. https:\/\/doi.org\/10.1021\/acs.analchem.8b02575.","DOI":"10.1021\/acs.analchem.8b02575"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_011","doi-asserted-by":"crossref","unstructured":"Tai, SSC, Bunk, DM, White, EV, Welch, MJ. Development and evaluation of a reference measurement procedure for the determination of total 3,3\u2032,5-trilodothyronine in human serum using isotope-dilution liquid chromatography-tandem mass spectrometry. Anal Chem 2004;76:5092\u20136. https:\/\/doi.org\/10.1021\/ac049516h.","DOI":"10.1021\/ac049516h"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_012","doi-asserted-by":"crossref","unstructured":"Tai, SSC, Sniegoski, LT, Welch, MJ. Candidate reference method for total thyroxine in human serum: use of isotope-dilution liquid chromatography-mass spectrometry with electrospray ionization. Clin Chem 2002;48:637\u201342. https:\/\/doi.org\/10.1093\/clinchem\/48.4.637.","DOI":"10.1093\/clinchem\/48.4.637"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_013","doi-asserted-by":"crossref","unstructured":"Tai, SS, Bedner, M, Phinney, KW. Development of a candidate reference measurement procedure for the determination of 25-hydroxyvitamin D3 and 25-hydroxyvitamin D2 in human serum using isotope-dilution liquid chromatography-tandem mass spectrometry. Anal Chem 2010;82:1942\u20138. https:\/\/doi.org\/10.1021\/ac9026862.","DOI":"10.1021\/ac9026862"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_014","doi-asserted-by":"crossref","unstructured":"Kilpatrick, LE, Phinney, KW. Quantification of total vitamin-D-binding protein and the glycosylated isoforms by liquid chromatography\u2013isotope dilution mass spectrometry. J Proteome Res 2017;16:4185\u201395. https:\/\/doi.org\/10.1021\/acs.jproteome.7b00560.","DOI":"10.1021\/acs.jproteome.7b00560"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_015","doi-asserted-by":"crossref","unstructured":"Kilpatrick, LE, Boggs, ASP, Davis, WC, Long, SE, Yen, JH, Phinney, KW. Assessing a method and reference material for quantification of vitamin D binding protein during pregnancy. Clin Mass Spec 2020;16:11\u20137. https:\/\/doi.org\/10.1016\/j.clinms.2020.01.002.","DOI":"10.1016\/j.clinms.2020.01.002"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_016","unstructured":"Centers for Disease Control and Prevention. Laboratory procedure manual for zinc, copper, and selenium. Available from https:\/\/wwwn.cdc.gov\/nchs\/data\/nhanes\/2015-2016\/labmethods\/CUSEZN_I_MET.PDF."},{"key":"2022031413522366226_j_cclm-2020-0977_ref_017","doi-asserted-by":"crossref","unstructured":"Wells, EM, Navas-Acien, A, Apelberg, BJ, Herbstman, JB, Jarrett, JM, Lin, YH, et al. Association of selenium and copper with lipids in umbilical cord blood. J Dev Orig Health Dis 2014;5:281\u20137. https:\/\/doi.org\/10.1017\/s2040174414000233.","DOI":"10.1017\/S2040174414000233"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_018","doi-asserted-by":"crossref","unstructured":"Wells, EM, Jarrett, JM, Lin, YH, Caldwell, KL, Hibbeln, JR, Apelberg, BJ, et al. Body burdens of mercury, lead, selenium and copper among Baltimore newborns. Environ Res 2011;111:411\u20137. https:\/\/doi.org\/10.1016\/j.envres.2010.12.009.","DOI":"10.1016\/j.envres.2010.12.009"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_019","doi-asserted-by":"crossref","unstructured":"Caudill, SP, Schleicher, RL, Pirkle, JL. Multi-rule quality control for the age-related eye disease study. Stat Med 2008;27:4094\u2013106. https:\/\/doi.org\/10.1002\/sim.3222.","DOI":"10.1002\/sim.3222"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_020","doi-asserted-by":"crossref","unstructured":"Netzel, BC, Grebe, SKG, Carranza Leon, BG, Castro, MR, Clark, PM, Hoofnagle, AN, et al. Thyroglobulin (Tg) testing revisited: Tg assays, TgAb assays, and correlation of results with clinical outcomes. J Clin Endocrinol Metab 2015;100:E1074\u2013E83. https:\/\/doi.org\/10.1210\/jc.2015-1967.","DOI":"10.1210\/jc.2015-1967"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_021","doi-asserted-by":"crossref","unstructured":"Beauchamp, CR, Camara, JE, Carney, J, Choquette, SJ, Cole, KD, DeRose, PC, et al.. NIST special publication 260-136: metrological tools for the reference materials and reference instruments of the NIST material measurement laboratory. Washington, DC: U.S. Government Printing Office; 2020 https:\/\/nvlpubs.nist.gov\/nistpubs\/SpecialPublications\/NIST.SP.260-136-2020.pdf.","DOI":"10.6028\/NIST.SP.260-136-2020"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_022","doi-asserted-by":"crossref","unstructured":"Soldin, OP, Tractenberg, RE, Hollowell, JG, Jonklaas, J, Janicic, N, Soldin, SJ. Trimester-specific changes in maternal thyroid hormone, thyrotropin, and thyroglobulin concentrations during gestation: trends and associations across trimesters in iodine sufficiency. Thyroid 2004;14:1084\u201390. https:\/\/doi.org\/10.1089\/thy.2004.14.1084.","DOI":"10.1089\/thy.2004.14.1084"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_023","doi-asserted-by":"crossref","unstructured":"B\u00e4rebring, L, Bullarbo, M, Glantz, A, Hulth\u00e9n, L, Ellis, J, Jagner, \u00c5, et al. Trajectory of vitamin D status during pregnancy in relation to neonatal birth size and fetal survival: a prospective cohort study. BMC Pregnancy Childbirth 2018;18:51. https:\/\/doi.org\/10.1186\/s12884-018-1683-7.","DOI":"10.1186\/s12884-018-1683-7"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_024","doi-asserted-by":"crossref","unstructured":"Mulligan, ML, Felton, SK, Riek, AE, Bernal-Mizrachi, C. Implications of vitamin D deficiency in pregnancy and lactation. Am J Obstet Gynecol 2010;202:429.e1\u20139. https:\/\/doi.org\/10.1016\/j.ajog.2009.09.002.","DOI":"10.1016\/j.ajog.2009.09.002"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_025","doi-asserted-by":"crossref","unstructured":"Hollis, BW, Wagner, CL. Assessment of dietary vitamin D requirements during pregnancy and lactation. Am J Clin Nutr 2004;79:717\u201326. https:\/\/doi.org\/10.1093\/ajcn\/79.5.717.","DOI":"10.1093\/ajcn\/79.5.717"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_026","doi-asserted-by":"crossref","unstructured":"Karras, SN, Koufakis, T, Fakhoury, H, Kotsa, K. Deconvoluting the biological roles of vitamin D-binding protein during pregnancy: a both clinical and theoretical challenge. Front Endocrinol 2018;9:259. https:\/\/doi.org\/10.3389\/fendo.2018.00259.","DOI":"10.3389\/fendo.2018.00259"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_027","doi-asserted-by":"crossref","unstructured":"Collins, JF, Prohaska, JR, Knutson, MD. Metabolic crossroads of iron and copper. Nutr Rev 2010;68:133\u201347. https:\/\/doi.org\/10.1111\/j.1753-4887.2010.00271.x.","DOI":"10.1111\/j.1753-4887.2010.00271.x"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_028","doi-asserted-by":"crossref","unstructured":"Vukelic, J, Kapamadzija, A, Petrovic, D, Grujic, Z, Novakov-Mikic, A, Kopitovic, V, et al. Variations of serum copper values in pregnancy. Srp Arh Celok Lek 2012;140:42\u20136. https:\/\/doi.org\/10.2298\/sarh1202042v.","DOI":"10.2298\/SARH1202042V"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_029","doi-asserted-by":"crossref","unstructured":"Varsi, K, Bolann, B, Torsvik, I, Rosvold Eik, TC, H\u00f8l, PJ, Bj\u00f8rke-Monsen, A-L. Impact of maternal selenium status on infant outcome during the first 6 Months of life. Nutrients 2017;9:486. https:\/\/doi.org\/10.3390\/nu9050486.","DOI":"10.3390\/nu9050486"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_030","doi-asserted-by":"crossref","unstructured":"Hotz, C, Peerson, JM, Brown, KH. Suggested lower cutoffs of serum zinc concentrations for assessing zinc status: reanalysis of the second National Health and Nutrition Examination Survey data (1976\u20131980). Am J Clin Nutr 2003;78:756\u201364. https:\/\/doi.org\/10.1093\/ajcn\/78.4.756.","DOI":"10.1093\/ajcn\/78.4.756"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_031","doi-asserted-by":"crossref","unstructured":"Glinoer, D. The regulation of thyroid function in pregnancy: pathways of endocrine adaptation from physiology to pathology. Endocr Rev 1997;18:404\u201333. https:\/\/doi.org\/10.1210\/edrv.18.3.0300.","DOI":"10.1210\/edrv.18.3.0300"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_032","doi-asserted-by":"crossref","unstructured":"Soh, SB, Aw, TC. Laboratory testing in thyroid conditions \u2013 pitfalls and clinical utility. Ann Lab Med 2019;39:3\u201314. https:\/\/doi.org\/10.3343\/alm.2019.39.1.3.","DOI":"10.3343\/alm.2019.39.1.3"},{"key":"2022031413522366226_j_cclm-2020-0977_ref_033","doi-asserted-by":"crossref","unstructured":"Mazzaferri, EL. Approach to the pregnant patient with thyroid cancer. J Clin Endocrinol Metab 2011;96:265\u201372. https:\/\/doi.org\/10.1210\/jc.2010-1624.","DOI":"10.1210\/jc.2010-1624"}],"container-title":["Clinical Chemistry and Laboratory Medicine (CCLM)"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.degruyter.com\/view\/journals\/cclm\/ahead-of-print\/article-10.1515-cclm-2020-0977\/article-10.1515-cclm-2020-0977.xml","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.degruyter.com\/document\/doi\/10.1515\/cclm-2020-0977\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.degruyter.com\/document\/doi\/10.1515\/cclm-2020-0977\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,8,16]],"date-time":"2024-08-16T21:24:24Z","timestamp":1723843464000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.degruyter.com\/document\/doi\/10.1515\/cclm-2020-0977\/html"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,10,26]]},"references-count":33,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2020,10,19]]},"published-print":{"date-parts":[[2021,3,26]]}},"alternative-id":["10.1515\/cclm-2020-0977"],"URL":"https:\/\/doi.org\/10.1515\/cclm-2020-0977","relation":{},"ISSN":["1434-6621","1437-4331"],"issn-type":[{"value":"1434-6621","type":"print"},{"value":"1437-4331","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,10,26]]}}}