{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T14:17:43Z","timestamp":1784557063422,"version":"3.55.0"},"reference-count":15,"publisher":"Bioscientifica","issue":"12","license":[{"start":{"date-parts":[[2024,10,18]],"date-time":"2024-10-18T00:00:00Z","timestamp":1729209600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["ec.bioscientifica.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2024,10,18]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Serum prolactin measurements are important in the differential diagnosis of pituitary masses and subfertility. We observed discrepancies in serum prolactin levels in several patients measured with different immunoassays. Despite differences in assay results, the reference intervals (RIs) derived by the manufacturers were similar. In this study, we aimed to investigate prolactin assay differences and to re-establish RIs for different prolactin immunoassays.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      For the assay comparison, serum samples were collected from men and women visiting the Amsterdam UMC hospital. Prolactin levels were measured using the Atellica\n                      <jats:sup>TM<\/jats:sup>\n                      IM analyzer (Siemens Healthineers) and the Cobas (Roche Diagnostics) immunoassay. RIs for prolactin were re-established for men, premenopausal women, and postmenopausal women for both the Atellica and Cobas immunoassay.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Prolactin levels measured using the Cobas immunoassay were 1.75 times higher than those measured using the Atellica immunoassay. The re-established RIs for Atellica and Cobas confirmed these findings and were &lt;0.32 U\/L; &lt;0.55 U\/L for men; &lt;0.64 U\/L; &lt;0.86 U\/L for premenopausal women, and &lt;0.31 U\/L; &lt;0.59 U\/L for postmenopausal women, respectively, for Atellica and Cobas assays. The re-established RIs of the Atellica assay matched the current and manufacturer RIs, whereas those for Cobas differed substantially.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Prolactin levels are assay-dependent, and the re-established RIs are different for the Atellica and Cobas assays. We recommend that laboratory specialists and manufacturers periodically review prolactin assay RIs, as incorrect RIs can lead to misinterpretation of prolactin levels and unnecessary referrals and further laboratory testing, as we have experienced.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Plain language summary<\/jats:title>\n                    <jats:p>We showed that the results of different prolactin tests disagree by 75%, which hinders correct interpretation. Thus, we established test-specific prolactin normal values. By being aware of test differences and using test-specific normal values, one can ensure correct interpretation and prevent unnecessary referrals and concern.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1530\/ec-24-0432","type":"journal-article","created":{"date-parts":[[2024,10,18]],"date-time":"2024-10-18T10:29:53Z","timestamp":1729247393000},"update-policy":"https:\/\/doi.org\/10.1530\/crossmarkpolicy-10","source":"Crossref","is-referenced-by-count":3,"title":["Confusion in the interpretation of prolactin levels caused by inappropriately low reference intervals"],"prefix":"10.1530","volume":"13","author":[{"given":"Yanaika S","family":"Sabogal Pi\u00f1eros","sequence":"first","affiliation":[{"name":"Endocrine Laboratory, Department of Laboratory Medicine, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martine M L","family":"Deckers","sequence":"additional","affiliation":[{"name":"OLVG Lab, Department of Clinical Chemistry, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-5050-9696","authenticated-orcid":true,"given":"Prim","family":"de Bie","sequence":"additional","affiliation":[{"name":"OLVG Lab, Department of Clinical Chemistry, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6712-9955","authenticated-orcid":true,"given":"Annemieke C","family":"Heijboer","sequence":"additional","affiliation":[{"name":"Endocrine Laboratory, Department of Laboratory Medicine, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands"},{"name":"Endocrine Laboratory, Department of Laboratory Medicine, Amsterdam UMC location Vrije Universiteit Amsterdam, Amsterdam, The Netherlands"},{"name":"Amsterdam Gastroenterology Endocrinology & Metabolism, Amsterdam, the Netherlands"},{"name":"Amsterdam Reproduction & Development Research Institute, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1161-0301","authenticated-orcid":true,"given":"Jacquelien J","family":"Hillebrand","sequence":"additional","affiliation":[{"name":"Endocrine Laboratory, Department of Laboratory Medicine, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands"},{"name":"Amsterdam Gastroenterology Endocrinology & Metabolism, Amsterdam, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"416","reference":[{"key":"bib1","series-title":"Physiological Reviews","first-page":"1523","article-title":"Prolactin: structure, function, and regulation of secretion","volume":"80","author":"Freeman","year":"2000","unstructured":"Freeman MEKanyicska BLerant A & Nagy G. Prolactin: structure, function, and regulation of secretion. Physiological Reviews 2000 80 1523\u20131631. (https:\/\/doi.org\/10.1152\/physrev.2000.80.4.1523)"},{"key":"bib2","series-title":"Journal of Clinical Endocrinology and Metabolism","first-page":"273","article-title":"Diagnosis and treatment of hyperprolactinemia: an Endocrine Society clinical practice guideline","volume":"96","author":"Melmed","year":"2011","unstructured":"Melmed SCasanueva FFHoffman ARKleinberg DLMontori VMSchlechte JA & Wass JAH. Diagnosis and treatment of hyperprolactinemia: an Endocrine Society clinical practice guideline. Journal of Clinical Endocrinology and Metabolism 2011 96 273\u2013288. (https:\/\/doi.org\/10.1210\/jc.2010-1692)"},{"key":"bib3","series-title":"StatPearls","article-title":"Physiol","author":"Al-Chalabi","year":"2024","unstructured":"Al-Chalabi MBass AN & Alsalman I Physiology, prolactin. In StatPearls. Treasure Island,FL, USA: StatPearls Publishing, 2024.  (https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK507829\/)"},{"key":"bib4","series-title":"Journal of Human Reproductive Sciences","first-page":"168","article-title":"Hyperprolactinemia","volume":"6","author":"Majumdar","year":"2013","unstructured":"Majumdar A & Mangal NS. Hyperprolactinemia. Journal of Human Reproductive Sciences 2013 6 168\u2013175. (https:\/\/doi.org\/10.4103\/0974-1208.121400)"},{"key":"bib5","series-title":"Journal of the Endocrine Society","first-page":"bvae069","article-title":"Clinical impact of new reference intervals for the Roche prolactin II immunoassay","volume":"8","author":"Earll","year":"2024","unstructured":"Earll EJavorsky BRSarvaideo JStraseski JA & Nerenz RD. Clinical impact of new reference intervals for the Roche prolactin II immunoassay. Journal of the Endocrine Society 2024 8 bvae069. (https:\/\/doi.org\/10.1210\/jendso\/bvae069)"},{"key":"bib6","series-title":"International Journal of Clinical Biochemistry and Research","first-page":"144","article-title":"Verification of Roche reference ranges for serum prolactin in children, adolescents, adults, and the elderly","volume":"10","author":"Ilardo","year":"2023","unstructured":"Ilardo CCoulon GEhrhard Y & Barthes J. Verification of Roche reference ranges for serum prolactin in children, adolescents, adults, and the elderly. International Journal of Clinical Biochemistry and Research 2023 10 144\u2013148. (https:\/\/doi.org\/10.18231\/j.ijcbr.2023.024)"},{"key":"bib7","series-title":"Endocrinology, Diabetes and Metabolism","first-page":"e00065","article-title":"Serum prolactin overestimation and risk of misdiagnosis","volume":"2","author":"De Sousa","year":"2019","unstructured":"De Sousa SMCSaleem MRankin W & Torpy DJ. Serum prolactin overestimation and risk of misdiagnosis. Endocrinology, Diabetes and Metabolism 2019 2 e00065. (https:\/\/doi.org\/10.1002\/edm2.65)"},{"key":"bib8","series-title":"Clinical Biochemist. Reviews","first-page":"3","article-title":"Prolactin biology and laboratory measurement: an update on physiology and current analytical issues","volume":"39","author":"Saleem","year":"2018","unstructured":"Saleem MMartin H & Coates P. Prolactin biology and laboratory measurement: an update on physiology and current analytical issues. Clinical Biochemist. Reviews 2018 39 3\u201316."},{"key":"bib9","series-title":"Clinical Chemistry","first-page":"1673","article-title":"Serum total prolactin and monomeric prolactin reference intervals determined by precipitation with polyethylene glycol: evaluation and validation on common immunoassay platforms","volume":"54","author":"Beltran","year":"2008","unstructured":"Beltran LFahie-Wilson MNMcKenna TJKavanagh L & Smith TP. Serum total prolactin and monomeric prolactin reference intervals determined by precipitation with polyethylene glycol: evaluation and validation on common immunoassay platforms. Clinical Chemistry 2008 54 1673\u20131681. (https:\/\/doi.org\/10.1373\/clinchem.2008.105312)"},{"key":"bib10","series-title":"BMC Endocrine Disorders","first-page":"197","article-title":"Establishment of reference intervals of monomeric prolactin to identify macroprolactinemia in Chinese patients with increased total prolactin","volume":"21","author":"Hu","year":"2021","unstructured":"Hu YNi JZhang BCheng WZhang HYe HJi LLu B & Guan M. Establishment of reference intervals of monomeric prolactin to identify macroprolactinemia in Chinese patients with increased total prolactin. BMC Endocrine Disorders 2021 21 197. (https:\/\/doi.org\/10.1186\/s12902-021-00861-z)"},{"key":"bib11","series-title":"Clinical Chemistry and Laboratory Medicine","first-page":"603","article-title":"A possible cause of the variable detectability of macroprolactin by different immunoassay systems","volume":"54","author":"Hattori","year":"2016","unstructured":"Hattori NAisaka K & Shimatsu A. A possible cause of the variable detectability of macroprolactin by different immunoassay systems. Clinical Chemistry and Laboratory Medicine 2016 54 603\u2013608. (https:\/\/doi.org\/10.1515\/cclm-2015-0484)"},{"key":"bib12","series-title":"Clinical Chemistry and Laboratory Medicine","first-page":"1352","article-title":"Should we depend on reference intervals from manufacturer package inserts? Comparing TSH and FT4 reference intervals from four manufacturers with results from modern indirect methods and the direct method","volume":"62","author":"Dirks","year":"2024","unstructured":"Dirks NFElzen den WPJHillebrand JJJansen HIBoekel ten ETBrinkman JBuijs MMDemir AYDijkstra IMEndenburg SC, et al. Should we depend on reference intervals from manufacturer package inserts? Comparing TSH and FT4 reference intervals from four manufacturers with results from modern indirect methods and the direct method. Clinical Chemistry and Laboratory Medicine 2024 62 1352\u20131361. (https:\/\/doi.org\/10.1515\/cclm-2023-1237)"},{"key":"bib13","series-title":"Journal of Clinical Endocrinology and Metabolism","first-page":"3975","article-title":"Treatment of symptoms of the menopause: an Endocrine Society clinical practice guideline","volume":"100","author":"Stuenkel","year":"2015","unstructured":"Stuenkel CADavis SRGompel ALumsden MAMurad MHPinkerton JV & Santen RJ. Treatment of symptoms of the menopause: an Endocrine Society clinical practice guideline. Journal of Clinical Endocrinology and Metabolism 2015 100 3975\u20134011. (https:\/\/doi.org\/10.1210\/jc.2015-2236)"},{"key":"bib14","series-title":"StatPearls","article-title":"Menop","author":"Peacock","year":"2024","unstructured":"Peacock KCarlson K & Ketvertis KM. Menopause. In StatPearls. Treasure Island,FL, USA: StatPearls Publishing, 2024. (https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK507826\/)"},{"key":"bib15","author":"Horowitz","unstructured":"Horowitz GLAltaie SBoyd JCCeriotti FGarg UHorn PPesce ASine HE & Defining Zakowski J.Wayne, PA, USA: Clinical and Laboratory Standards Institute."}],"container-title":["Endocrine Connections"],"original-title":[],"link":[{"URL":"https:\/\/ec.bioscientifica.com\/view\/journals\/ec\/13\/12\/EC-24-0432.xml","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ec.bioscientifica.com\/downloadpdf\/journals\/ec\/13\/12\/EC-24-0432.xml","content-type":"text\/html","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/ec.bioscientifica.com\/downloadpdf\/journals\/ec\/13\/12\/EC-24-0432.xml","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T13:47:29Z","timestamp":1784555249000},"score":1,"resource":{"primary":{"URL":"http:\/\/journals.bioscientifica.com\/ec\/article\/1221"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,10,18]]},"references-count":15,"journal-issue":{"issue":"12"},"URL":"https:\/\/doi.org\/10.1530\/ec-24-0432","relation":{},"ISSN":["2049-3614"],"issn-type":[{"value":"2049-3614","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,10,18]]}}}