Validation of plasma thyroxine and triiodothyronine methods on the ADVIA Centaur^® XP

References

• Ling C, Sun Q, Khang J, et al. Does TSH reliably detect hypothyroid patients? Ann Thyroid Res. 2018;4:122–125.
   PubMedGoogle Scholar
• Welsh KJ, Soldin SJ. Diagnosis of endocrine disease: how reliable are free thyroid and total T3 hormone assays? Eur J Endocrinol. 2016;175:R255–R263.
   PubMed Web of Science ®Google Scholar
• Masika LS, Zhao Z, Soldin SJ. Is measurement of TT3 by immunoassay reliable at low concentrations? A comparison of the Roche Cobas 6000 vs. LC-MSMS. Clin Biochem. 2016;49:846–849.
   PubMed Web of Science ®Google Scholar
• Thienpont LM, Franzini C, Kratochvila J, et al. Analytical quality specifications for reference methods and operating specifications for networks of reference laboratories. Discussion paper from the members of the external quality assessment (EQA) working group B1) on target values in EQAS. Eur J Clin Chem Clin Biochem. 1995;33:949–957.
   PubMedGoogle Scholar
• Thienpont LM, Fierens C, De Leenheer AP, et al. Isotope dilution-gas chromatography/mass spectrometry and liquid chromatography/electrospray ionization-tandem mass spectrometry for the determination of triiodo-L-thyronine in serum. Rapid Commun Mass Spectrom. 1999;13:1924–1931.
   PubMedGoogle Scholar
• Thienpont LM, Van Uytfanghe K, Marriot J, et al. Metrologic traceability of total thyroxine measurements in human serum: efforts to establish a network of reference measurement laboratories. Clin Chem. 2004;51:161–168.
   PubMed Web of Science ®Google Scholar
• Thienpont LM, Beastall G, Christofides ND, et al. Measurement of free thyroxine in laboratory medicine–proposal of measurand definition. Clin Chem Lab Med. 2007;45:563–564.
   PubMed Web of Science ®Google Scholar
• Thienpont LM, Van Uytfanghe K, Beastall G, et al. Report of the IFCC working group for standardization of thyroid function tests; part 2: free thyroxine and free triiodothyronine. Clin Chem. 2010;56:912–920.
   PubMed Web of Science ®Google Scholar
• Thienpont LM, Van Uytfanghe K, Beastall G, et al. Report of the IFCC working group for standardization of thyroid function tests; part 3: total thyroxine and total triiodothyronine. Clin Chem. 2010;56:921–929.
   PubMed Web of Science ®Google Scholar
• Thienpont LM, Van Uytfanghe K, Van Houcke SK, et al. A progress report of the IFCC committee for standardization of thyroid function tests. Eur Thyroid J. 2014;3:109–116.
   PubMedGoogle Scholar
• De Brabandere VI, Hou P, Stockl D, et al. Isotope dilution-liquid chromatography/electrospray ionization-tandem mass spectrometry for the determination of serum thyroxine as a potential reference method. Rapid Commun Mass Spectrom. 1998;12:1099–1103.
   PubMedGoogle Scholar
• Thienpont LM, Van Uytfanghe K, Beastall G, et al. Report of the IFCC working group for standardization of thyroid function tests; part 1: thyroid-stimulating hormone. Clin Chem. 2010;56:902–911.
   PubMed Web of Science ®Google Scholar
• Siemens. T4. ADVIA Centaur® XP immunoassay systems. Siemens HealthCare Diagnostics Inc. 2015;Rev. R:1-16.
   Google Scholar
• Siemens. FT3. ADVIA Centaur® XP immunoassay systems. Siemens HealthCare Diagnostics Inc. 2015;Rev. M:1-12.
   Google Scholar
• Siemens. T3. ADVIA Centaur® XP immunoassay systems. Siemens HealthCare Diagnostics Inc. 2015;Rev H:1-16.
   Google Scholar
• Siemens. FT4. ADVIA Centaur® XP. Immunoassay systems. Siemens Healthcare Diagnostics Inc. 2015;Rev H:1-12.
   Google Scholar
• Thienpont LM, Van Uytfanghe K, Marriott J, et al. Feasibility study of the use of frozen human sera in split-sample comparison of immunoassays with candidate reference measurement procedures for total thyroxine and total triiodothyronine measurements. Clin Chem. 2005;51:2303–2311.
   PubMed Web of Science ®Google Scholar
• Horowitz G, Altai S, Boyd JC, et al. Defining, establishing, and verifying reference intervals in the clinical laboratory; approved guideline. Clinical & Laboratory Standards Institute. 2010;EP28EA3C.
   Google Scholar
• Van Houcke SK, Van Uytfanghe K, Shimizu E, et al. IFCC international conventional reference procedure for the measurement of free thyroxine in serum: International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working group for Standardization of Thyroid Function tests. Clin Chem Lab Med. 2011;49:1275–1281.
   PubMed Web of Science ®Google Scholar
• Ullman EF, Kirakossian H, Singh S, et al. Luminescent oxygen channeling immunoassay: measurement of particle binding kinetics by chemiluminescence. Proc Natl Acad Sci USA. 1994;91:5426–5430.
   PubMed Web of Science ®Google Scholar
• Siemens. Dimension Vista® System. Flex reagent cartridge. LOCI thyroid stimulating hormone. Siemens Healthcare Diagnostics Inc. 2015; REF K6412.
   Google Scholar
• Gaines Das RE, Bristow AF. The second international reference preparation of thyroid-stimulating hormone, human, for immunoassay: calibration by bioassay and immunoassay in an international collaborative study. J Endocrinol. 1985;104:367–379.
   PubMed Web of Science ®Google Scholar
• Siemens. Dimension® and Dimension Vista® Assay. Biotin interference – Instruction for use (IFU) information. Urgent Field Safety Notice – Follow Up. Siemens HealthCare Diagnostics Inc 2017.
   Google Scholar
• Siemens. ADVIA Centaur® XP. Biotin Interference in Certain Immunoassays. Customer Bulletin. Siemens HealthCare Diagnostics Inc. 2018;11314506.
   Google Scholar
• Solberg HE. RefVal: A program implementing the recommendations of the international federation of clinical chemistry on the statistical treatment of reference values. Comput Methods Programs Biomed. 1995;48:247–256.
   PubMed Web of Science ®Google Scholar
• Solberg HE. The IFCC recommendation on estimation of reference intervals. The RefVal program. Clin Chem Lab Med. 2004;42:710–714.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Thienpont LM, Faix JD, Beastall G. Standardization of free T4 and harmonization of TSH measurements: a request for input from endocrinologists and other physicians. Eur Thyroid J. 2015;4:271–272.
   PubMed Web of Science ®Google Scholar
• Hollowell JG, Staehling NW, Flanders WD, et al. Serum TSH, T4, and thyroid antibodies in the united states population (1988 to 1994): national health and nutrition examination survey (NHANES III). J Clin Endocrinol Metab. 2002;87:489–499.
   PubMed Web of Science ®Google Scholar
• Friis-Hansen L, Hilsted L. Reference intervals for thyreotropin and thyroid hormones for healthy adults based on the NOBIDA material and determined using a modular E170. Clin Chem Lab Med. 2008;46:1305–1312.
   PubMed Web of Science ®Google Scholar
• Surks MI, Ortiz E, Daniels GH, et al. Subclinical thyroid disease: scientific review and guidelines for diagnosis and management. JAMA. 2004;291:228–238.
   PubMed Web of Science ®Google Scholar
• Jensen E, Blaabjerg O, Petersen PH, et al. Sampling time is important but may be overlooked in establishment and use of thyroid-stimulating hormone reference intervals. Clin Chem. 2007;53:355–356.
   PubMed Web of Science ®Google Scholar
• De Grande LA, Goossens K, Van Uytfanghe K, et al. Using “big data” to describe the effect of seasonal variation in thyroid-stimulating hormone. Clin Chem Lab Med. 2017;55:34–36.
   Web of Science ®Google Scholar
• Jensen E, Hyltoft Petersen P, Blaabjerg O, et al. Establishment of a serum thyroid stimulating hormone (TSH) reference interval in healthy adults. the importance of environmental factors, including thyroid antibodies. Clin Chem Lab Med. 2004;42:824–832.
   PubMed Web of Science ®Google Scholar
• Thienpont LM, Beastall G, Christofides ND, et al. Proposal of a candidate international conventional reference measurement procedure for free thyroxine in serum. Clin Chem Lab Med. 2007;45:934–936.
   PubMed Web of Science ®Google Scholar
• Barth JH, Spencer JD, Goodall SR, et al. Reference intervals for thyroid hormones on Advia Centaur derived from three reference populations and a review of the literature. Ann Clin Biochem. 2016;53:385–389.
   PubMed Web of Science ®Google Scholar
• Reix N, Massart C, d'Herbomez M, et al. Thyroid-stimulating hormone and free thyroxine on the ADVIA Centaur immunoassay system: a multicenter assessment of analytical performance. Clin Biochem. 2013;46:1305–1308.
   PubMed Web of Science ®Google Scholar
• Horn PS, Pesce AJ, Copeland BE. A robust approach to reference interval estimation and evaluation. Clin Chem. 1998;44:622–631.
   PubMed Web of Science ®Google Scholar
• Kristiansen S, Friis-Hansen L, Antonio Juel Jensen C, et al. Verification study on the NORIP LDH reference intervals with a proposed new upper reference limit. Scand J Clin Lab Invest. 2018;78:421–427.
   PubMed Web of Science ®Google Scholar
• Lykkeboe S, Nielsen CG, Christensen PA. Indirect method for validating transference of reference intervals. Clin Chem Lab Med. 2018;56:463–470.
   PubMed Web of Science ®Google Scholar
• Carle A, Laurberg P, Pedersen IB, et al. Epidemiology of subtypes of hyperthyroidism in Denmark: a population-based study. Eur J Endocrinol. 2011;164:801–809.
   PubMed Web of Science ®Google Scholar
• Carle A, Pedersen IB, Knudsen N, et al. Epidemiology of subtypes of hypothyroidism in Denmark. Eur J Endocrinol. 2006;154:21–28.
   PubMed Web of Science ®Google Scholar
• Laurberg P, Jorgensen 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.
   PubMed Web of Science ®Google Scholar