PMID- 26079778 OWN - NLM STAT- MEDLINE DCOM- 20151124 LR - 20230411 IS - 1945-7197 (Electronic) IS - 0021-972X (Print) IS - 0021-972X (Linking) VI - 100 IP - 8 DP - 2015 Aug TI - Thyroglobulin (Tg) Testing Revisited: Tg Assays, TgAb Assays, and Correlation of Results With Clinical Outcomes. PG - E1074-83 LID - 10.1210/jc.2015-1967 [doi] AB - CONTEXT: Measurement of thyroglobulin (Tg) by mass spectrometry (Tg-MS) is emerging as a tool for accurate Tg quantification in patients with anti-Tg autoantibodies (TgAbs). OBJECTIVE: The objective of the study was to perform analytical and clinical evaluations of two Tg-MS assays in comparison with immunometric Tg assays (Tg-IAs) and Tg RIAs (Tg-RIAs) in a cohort of thyroid cancer patients. METHODS: A total of 589 samples from 495 patients, 243 TgAb-/252 TgAb+, were tested by Beckman, Roche, Siemens-Immulite, and Thermo-Brahms Tg and TgAb assays, two Tg-RIAs, and two Tg-MS assays. RESULTS: The frequency of TgAb+ was 58%, 41%, 27%, and 39% for Roche, Beckman, Siemens-Immulite, and Thermo-Brahms, respectively. In TgAb- samples, clinical sensitivities and specificities of 100% and 74%-100%, respectively, were observed across all assays. In TgAb+ samples, all Tg-IAs demonstrated assay-dependent Tg underestimation, ranging from 41% to 86%. In TgAb+ samples, the use of a common cutoff (0.5 ng/mL) for the Tg-MS, three Tg-IAs, and the USC-RIA improved the sensitivity for the Tg-MSs and Tg-RIAs when compared with the Tg-IAs. In up to 20% of TgAb+ cases, Tg-IAs failed to detect Tg that was detectable by Tg-MS. In Tg-RIAs false-high biases were observed in TgAb+ samples containing low Tg concentrations. CONCLUSIONS: Tg-IAs remain the method of choice for Tg quantitation in TgAb- patients. In TgAb+ patients with undetectable Tg by immunometric assay, the Tg-MS will detect Tg in up to 20% additional cases. The Tg-RIA will detect Tg in approximately 35% cases, but a significant proportion of these will be clinical false-positive results. The undetectable Tg-MS seen in approximately 40% of TgAb+ cases in patients with disease need further evaluation. FAU - Netzel, Brian C AU - Netzel BC AD - Department of Laboratory Medicine and Pathology (B.C.N., S.K.G.G., A.A.-S.), Division of Endocrinology, Metabolism, and Nutrition (S.K.G.G., B.G.C.L., M.R.C., A.F.T.), Mayo Clinic, Rochester, Minnesota 55905; Queen Elizabeth Hospital Birmingham (P.M.C.), Birmingham B15 2TH, United Kingdom; Department of Laboratory Medicine (A.N.H.), University of Washington, Seattle, Washington 98108; and University of Southern California (C.A.S.), Los Angeles, California 90089. FAU - Grebe, Stefan K G AU - Grebe SK AD - Department of Laboratory Medicine and Pathology (B.C.N., S.K.G.G., A.A.-S.), Division of Endocrinology, Metabolism, and Nutrition (S.K.G.G., B.G.C.L., M.R.C., A.F.T.), Mayo Clinic, Rochester, Minnesota 55905; Queen Elizabeth Hospital Birmingham (P.M.C.), Birmingham B15 2TH, United Kingdom; Department of Laboratory Medicine (A.N.H.), University of Washington, Seattle, Washington 98108; and University of Southern California (C.A.S.), Los Angeles, California 90089. FAU - Carranza Leon, B Gisella AU - Carranza Leon BG AD - Department of Laboratory Medicine and Pathology (B.C.N., S.K.G.G., A.A.-S.), Division of Endocrinology, Metabolism, and Nutrition (S.K.G.G., B.G.C.L., M.R.C., A.F.T.), Mayo Clinic, Rochester, Minnesota 55905; Queen Elizabeth Hospital Birmingham (P.M.C.), Birmingham B15 2TH, United Kingdom; Department of Laboratory Medicine (A.N.H.), University of Washington, Seattle, Washington 98108; and University of Southern California (C.A.S.), Los Angeles, California 90089. FAU - Castro, M Regina AU - Castro MR AD - Department of Laboratory Medicine and Pathology (B.C.N., S.K.G.G., A.A.-S.), Division of Endocrinology, Metabolism, and Nutrition (S.K.G.G., B.G.C.L., M.R.C., A.F.T.), Mayo Clinic, Rochester, Minnesota 55905; Queen Elizabeth Hospital Birmingham (P.M.C.), Birmingham B15 2TH, United Kingdom; Department of Laboratory Medicine (A.N.H.), University of Washington, Seattle, Washington 98108; and University of Southern California (C.A.S.), Los Angeles, California 90089. FAU - Clark, Penelope M AU - Clark PM AD - Department of Laboratory Medicine and Pathology (B.C.N., S.K.G.G., A.A.-S.), Division of Endocrinology, Metabolism, and Nutrition (S.K.G.G., B.G.C.L., M.R.C., A.F.T.), Mayo Clinic, Rochester, Minnesota 55905; Queen Elizabeth Hospital Birmingham (P.M.C.), Birmingham B15 2TH, United Kingdom; Department of Laboratory Medicine (A.N.H.), University of Washington, Seattle, Washington 98108; and University of Southern California (C.A.S.), Los Angeles, California 90089. FAU - Hoofnagle, Andrew N AU - Hoofnagle AN AD - Department of Laboratory Medicine and Pathology (B.C.N., S.K.G.G., A.A.-S.), Division of Endocrinology, Metabolism, and Nutrition (S.K.G.G., B.G.C.L., M.R.C., A.F.T.), Mayo Clinic, Rochester, Minnesota 55905; Queen Elizabeth Hospital Birmingham (P.M.C.), Birmingham B15 2TH, United Kingdom; Department of Laboratory Medicine (A.N.H.), University of Washington, Seattle, Washington 98108; and University of Southern California (C.A.S.), Los Angeles, California 90089. FAU - Spencer, Carole A AU - Spencer CA AD - Department of Laboratory Medicine and Pathology (B.C.N., S.K.G.G., A.A.-S.), Division of Endocrinology, Metabolism, and Nutrition (S.K.G.G., B.G.C.L., M.R.C., A.F.T.), Mayo Clinic, Rochester, Minnesota 55905; Queen Elizabeth Hospital Birmingham (P.M.C.), Birmingham B15 2TH, United Kingdom; Department of Laboratory Medicine (A.N.H.), University of Washington, Seattle, Washington 98108; and University of Southern California (C.A.S.), Los Angeles, California 90089. FAU - Turcu, Adina F AU - Turcu AF AD - Department of Laboratory Medicine and Pathology (B.C.N., S.K.G.G., A.A.-S.), Division of Endocrinology, Metabolism, and Nutrition (S.K.G.G., B.G.C.L., M.R.C., A.F.T.), Mayo Clinic, Rochester, Minnesota 55905; Queen Elizabeth Hospital Birmingham (P.M.C.), Birmingham B15 2TH, United Kingdom; Department of Laboratory Medicine (A.N.H.), University of Washington, Seattle, Washington 98108; and University of Southern California (C.A.S.), Los Angeles, California 90089. FAU - Algeciras-Schimnich, Alicia AU - Algeciras-Schimnich A AD - Department of Laboratory Medicine and Pathology (B.C.N., S.K.G.G., A.A.-S.), Division of Endocrinology, Metabolism, and Nutrition (S.K.G.G., B.G.C.L., M.R.C., A.F.T.), Mayo Clinic, Rochester, Minnesota 55905; Queen Elizabeth Hospital Birmingham (P.M.C.), Birmingham B15 2TH, United Kingdom; Department of Laboratory Medicine (A.N.H.), University of Washington, Seattle, Washington 98108; and University of Southern California (C.A.S.), Los Angeles, California 90089. LA - eng GR - P30 DK035816/DK/NIDDK NIH HHS/United States GR - U24 CA160034/CA/NCI NIH HHS/United States GR - CA160034/CA/NCI NIH HHS/United States GR - DK035816/DK/NIDDK NIH HHS/United States PT - Comparative Study PT - Evaluation Study PT - Journal Article PT - Research Support, N.I.H., Extramural DEP - 20150616 PL - United States TA - J Clin Endocrinol Metab JT - The Journal of clinical endocrinology and metabolism JID - 0375362 RN - 0 (Autoantibodies) RN - 0 (anti-thyroglobulin) RN - 9010-34-8 (Thyroglobulin) SB - IM CIN - J Clin Endocrinol Metab. 2016 Mar;101(3):L38-9. PMID: 26938377 MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Autoantibodies/*analysis/blood MH - Chromatography, Liquid MH - Cohort Studies MH - Female MH - Humans MH - Male MH - Middle Aged MH - Predictive Value of Tests MH - Prognosis MH - Radioimmunoassay/methods MH - Tandem Mass Spectrometry MH - Thyroglobulin/*analysis/blood MH - *Thyroid Function Tests/methods/standards MH - Thyroid Neoplasms/blood/*diagnosis MH - Young Adult PMC - PMC4524993 EDAT- 2015/06/17 06:00 MHDA- 2015/12/15 06:00 PMCR- 2015/06/16 CRDT- 2015/06/17 06:00 PHST- 2015/06/17 06:00 [entrez] PHST- 2015/06/17 06:00 [pubmed] PHST- 2015/12/15 06:00 [medline] PHST- 2015/06/16 00:00 [pmc-release] AID - 15-1967 [pii] AID - 10.1210/jc.2015-1967 [doi] PST - ppublish SO - J Clin Endocrinol Metab. 2015 Aug;100(8):E1074-83. doi: 10.1210/jc.2015-1967. Epub 2015 Jun 16.