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Available laboratory reference ranges for blood FGF23 were developed using samples from normophosphatemic individuals. Reliance on such values can lead to misdiagnosis in patients with FGF23-mediated hypophosphatemia, such as X-linked hypophosphatemia (XLH) and tumor-induced osteomalacia (TIO), in whom pathology-driving FGF23 levels can be in the \u201cnormal range.\u201d To determine FGF23 levels that are diagnostic for the identification of patients with FGF23-mediated hypophosphatemic disorders, we studied 149 patients with various disorders of FGF23-mediated and FGF23-independent hypophosphatemia and defined cut-off levels for both intact FGF23 (iFGF23) and C-terminal FGF23 (cFGF23) that can accurately distinguish between FGF23-mediated and FGF23-independent hypophosphatemia. In addition, to demonstrate the relationship between FGF23 and phosphate across the spectrum of human physiology, we assessed blood levels of FGF23 and phosphate in 434 patients with various forms of hypophosphatemia, hyperphosphatemia, and normophosphatemia. An intact FGF23 cut point of 27\u2009pg\/mL was 100% sensitive and specific in distinguishing FGF23-mediated from FGF23-independent hypophosphatemia, and a cFGF23 cut point of 90 RU\/mL was 100% sensitive and specific in distinguishing specifically TIO from FGF23-independent hypophosphatemia. There was overlap in the cFGF23 range of 45\u201390 RU\/mL between genetic forms of FGF23 excess and FGF23-independent hypophosphatemia, substantiating the superiority of iFGF23 over cFGF23 in making the diagnosis of FGF23-mediated hypophosphatemia. In this cohort, using the laboratory upper limit of normal for cFGF23 (180 RU\/mL) would result in a misdiagnosis in more than half of patients with FGF23-mediated hypophosphatemia. In this, the largest study of FGF23 in chronic hypophosphatemia to date, we established iFGF23 and cFGF23 cut-off values to assist in the evaluation and diagnosis of hypophosphatemic conditions. \u00a9 2022 American Society for Bone and Mineral Research (ASBMR). This article has been contributed to by US Government employees and their work is in the public domain in the USA.<\/jats:p>\n                  <jats:p>Abstract<\/jats:p>\n                  <jats:p>Fibroblast growth factor-23 (FGF23) measurement is a critical tool in the evaluation of chronic hypophosphatemia. Reliance on laboratory reference ranges, developed from normophosphatemic individuals, however, can lead to misdiagnosis in patients with FGF23-mediated hypophosphatemia in whom pathology-driving FGF23 levels can be \u201cinappropriately normal.\u201d In this study, we establish clinically useful diagnostic cut points for both intact FGF23 (iFGF23, 27\u2009pg\/mL) and c-terminal FGF23 (cFGF23, 45\u201390\u2009RU\/mL) to accurately distinguish between FGF23-mediated and FGF23-independent hypophosphatemia.<\/jats:p>","DOI":"10.1002\/jbmr.4702","type":"journal-article","created":{"date-parts":[[2022,9,12]],"date-time":"2022-09-12T05:34:47Z","timestamp":1662960887000},"page":"2174-2185","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":39,"title":["Determination of FGF23 Levels for the Diagnosis of FGF23-Mediated Hypophosphatemia"],"prefix":"10.1093","volume":"37","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1029-3284","authenticated-orcid":false,"given":"Iris R.","family":"Hartley","sequence":"first","affiliation":[{"name":"Skeletal Disorders and Mineral Homeostasis Section National Institutes of Dental and Craniofacial Research. National Institutes of Health Bethesda MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7970-3491","authenticated-orcid":false,"given":"Rachel I.","family":"Gafni","sequence":"additional","affiliation":[{"name":"Skeletal Disorders and Mineral Homeostasis Section National Institutes of Dental and Craniofacial Research. National Institutes of Health Bethesda MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0284-5299","authenticated-orcid":false,"given":"Kelly L.","family":"Roszko","sequence":"additional","affiliation":[{"name":"Skeletal Disorders and Mineral Homeostasis Section National Institutes of Dental and Craniofacial Research. National Institutes of Health Bethesda MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sydney M.","family":"Brown","sequence":"additional","affiliation":[{"name":"Skeletal Disorders and Mineral Homeostasis Section National Institutes of Dental and Craniofacial Research. National Institutes of Health Bethesda MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3194-9780","authenticated-orcid":false,"given":"Luis F.","family":"de Castro","sequence":"additional","affiliation":[{"name":"Skeletal Disorders and Mineral Homeostasis Section National Institutes of Dental and Craniofacial Research. National Institutes of Health Bethesda MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amanda","family":"Saikali","sequence":"additional","affiliation":[{"name":"Skeletal Disorders and Mineral Homeostasis Section National Institutes of Dental and Craniofacial Research. National Institutes of Health Bethesda MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2697-1046","authenticated-orcid":false,"given":"Carlos R.","family":"Ferreira","sequence":"additional","affiliation":[{"name":"Metabolic Medicine Branch National Human Genome Research Institute, National Institutes of Health Bethesda MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2494-6752","authenticated-orcid":false,"given":"William A.","family":"Gahl","sequence":"additional","affiliation":[{"name":"Medical Genetics Branch, National Human Genome Research Institute National Institutes of Health Bethesda MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3541-3767","authenticated-orcid":false,"given":"Karel","family":"Pacak","sequence":"additional","affiliation":[{"name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health Bethesda MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6725-4262","authenticated-orcid":false,"given":"Jenny E.","family":"Blau","sequence":"additional","affiliation":[{"name":"National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health Bethesda MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2725-2908","authenticated-orcid":false,"given":"Alison M.","family":"Boyce","sequence":"additional","affiliation":[{"name":"Skeletal Disorders and Mineral Homeostasis Section National Institutes of Dental and Craniofacial Research. National Institutes of Health Bethesda MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8052-416X","authenticated-orcid":false,"given":"Isidro B.","family":"Salusky","sequence":"additional","affiliation":[{"name":"Division of Nephrology, Department of Pediatrics David Geffen School of Medicine at University of California Los Angeles CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3676-7644","authenticated-orcid":false,"given":"Michael T.","family":"Collins","sequence":"additional","affiliation":[{"name":"Skeletal Disorders and Mineral Homeostasis Section National Institutes of Dental and Craniofacial Research. National Institutes of Health Bethesda MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5936-3146","authenticated-orcid":false,"given":"Pablo","family":"Florenzano","sequence":"additional","affiliation":[{"name":"School of Medicine, Pontificia Universidad Catolica de Chile Centro Traslacional en Endocrinolog\u00eda UC (CETREN-UC) Santiago Chile"},{"name":"Department of Endocrinology School of Medicine, Pontificia Universidad Cat\u00f3lica de Chile Santiago Chile"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2022,9,12]]},"reference":[{"issue":"2","key":"2024012714071142300_jbmr4702-bib-0001","doi-asserted-by":"crossref","first-page":"163","DOI":"10.1016\/S2213-8587(19)30426-7","article-title":"Approach to patients with hypophosphataemia","volume":"8","author":"Florenzano","year":"2020","journal-title":"Lancet Diabetes Endocrinol"},{"issue":"10","key":"2024012714071142300_jbmr4702-bib-0002","doi-asserted-by":"crossref","first-page":"1870","DOI":"10.1002\/jbmr.3522","article-title":"Skeletal consequences of Nephropathic Cystinosis","volume":"33","author":"Florenzano","year":"2018","journal-title":"J Bone Miner Res"},{"issue":"9","key":"2024012714071142300_jbmr4702-bib-0003","doi-asserted-by":"crossref","first-page":"1825","DOI":"10.1007\/s00198-021-05875-w","article-title":"Clinical and molecular characterization of Chilean patients with X-linked hypophosphatemia","volume":"32","author":"Jimenez","year":"2021","journal-title":"Osteoporos Int"},{"issue":"10","key":"2024012714071142300_jbmr4702-bib-0004","doi-asserted-by":"crossref","first-page":"3378","DOI":"10.1096\/fj.201600473R","article-title":"Hypophosphatemia promotes lower rates of muscle ATP synthesis","volume":"30","author":"Pesta","year":"2016","journal-title":"FASEB J"},{"issue":"1","key":"2024012714071142300_jbmr4702-bib-0005","doi-asserted-by":"crossref","first-page":"128","DOI":"10.1007\/s00223-020-00691-6","article-title":"Tumor-induced Osteomalacia","volume":"108","author":"Florenzano","year":"2021","journal-title":"Calcif Tissue Int"},{"issue":"12","key":"2024012714071142300_jbmr4702-bib-0006","doi-asserted-by":"crossref","first-page":"2183","DOI":"10.1002\/jbmr.3843","article-title":"Burosumab improved Histomorphometric measures of Osteomalacia in adults with X-linked hypophosphatemia: a phase 3, single-arm, international trial","volume":"34","author":"Insogna","year":"2019","journal-title":"J Bone Miner Res"},{"issue":"2","key":"2024012714071142300_jbmr4702-bib-0007","doi-asserted-by":"crossref","first-page":"179","DOI":"10.1002\/jbmr.4429","article-title":"PTH and FGF23 exert interdependent effects on renal phosphate handling: evidence from patients with hypoparathyroidism and Hyperphosphatemic familial Tumoral calcinosis treated with synthetic human PTH 1-34","volume":"37","author":"Ovejero","year":"2022","journal-title":"J Bone Miner Res"},{"issue":"5","key":"2024012714071142300_jbmr4702-bib-0008","doi-asserted-by":"crossref","first-page":"683","DOI":"10.1172\/JCI18399","article-title":"FGF-23 in fibrous dysplasia of bone and its relationship to renal phosphate wasting","volume":"112","author":"Riminucci","year":"2003","journal-title":"J Clin Invest"},{"issue":"6","key":"2024012714071142300_jbmr4702-bib-0009","doi-asserted-by":"crossref","first-page":"1637","DOI":"10.1681\/ASN.2007010068","article-title":"How fibroblast growth factor 23 works","volume":"18","author":"Liu","year":"2007","journal-title":"J Am Soc Nephrol"},{"issue":"2","key":"2024012714071142300_jbmr4702-bib-0010","doi-asserted-by":"crossref","first-page":"165","DOI":"10.1007\/s11154-015-9318-z","article-title":"The PTH-vitamin D-FGF23 axis","volume":"16","author":"Blau","year":"2015","journal-title":"Rev Endocr Metab Disord"},{"issue":"2","key":"2024012714071142300_jbmr4702-bib-0011","doi-asserted-by":"crossref","first-page":"344","DOI":"10.2215\/CJN.05840513","article-title":"Disordered FGF23 and mineral metabolism in children with CKD","volume":"9","author":"Portale","year":"2014","journal-title":"Clin J Am Soc Nephrol"},{"issue":"3","key":"2024012714071142300_jbmr4702-bib-0012","doi-asserted-by":"crossref","first-page":"696","DOI":"10.1210\/jc.2011-1319","article-title":"Approach to the hypophosphatemic patient","volume":"97","author":"Imel","year":"2012","journal-title":"J Clin Endocrinol Metab"},{"issue":"12","key":"2024012714071142300_jbmr4702-bib-0013","doi-asserted-by":"crossref","first-page":"3615","DOI":"10.1007\/s00198-016-3702-8","article-title":"Cutaneous skeletal hypophosphatemia syndrome: clinical spectrum, natural history, and treatment","volume":"27","author":"Ovejero","year":"2016","journal-title":"Osteoporos Int"},{"issue":"3","key":"2024012714071142300_jbmr4702-bib-0014","doi-asserted-by":"crossref","first-page":"404","DOI":"10.4067\/S0034-98872020000300404","article-title":"Hypophosphatemia induced by carboxymaltose iron and imatinib. 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