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AACC POSITION STATEMENT - Harmonization of clinical laboratory test results [Web site], 2013. Available at: https://www.harmonization.net/media/1087/aacc_harmonization_position_statement_2013.pdf. Accessed June 7, 2018.
- Roadmap for harmonization of clinical laboratory measurement procedures.Clin Chem. 2011; 57: 1108-1117
- Challenges and improvements in testosterone and estradiol testing.Asian J Androl. 2014; 16: 178-184
- Baseline assessment of 25-Hydroxyvitamin D reference material and proficiency testing/external quality assurance material commutability: a vitamin D standardization program study.J AOAC Int. 2017; 100: 1288-1293
- Specificity of B-type natriuretic peptide assays: cross-reactivity with different BNP, NT-proBNP, and proBNP peptides.Clin Chem. 2017; 63: 351-358
- Are liquid chromatography/electrospray tandem quadrupole fragmentation ratios unequivocal confirmation criteria?.Rapid Commun mass Spectrom. 2009; 23: 985-998
- Effect of mobile phase pH, aqueous-organic ratio, and buffer concentration on electrospray ionization tandem mass spectrometric fragmentation patterns: implications in liquid chromatography/tandem mass spectrometric bioanalysis.Rapid Commun mass Spectrom. 2010; 24: 3221-3229
- IFCC working group recommendations for assessing commutability part 2: using the difference in bias between a reference material and clinical samples.Clin Chem. 2018; 64: 455-464
- IFCC working group recommendations for assessing commutability part 1: general experimental design.Clin Chem. 2018; 64: 447-454
- IFCC working group recommendations for assessing commutability part 3: using the calibration effectiveness of a reference material.Clin Chem. 2018; 64: 465-474
- Thyroglobulin (Tg) testing revisited: Tg assays, Tgab assays, and correlation of results with clinical outcomes.J Clin Endocrinol Metab. 2015; 100: E1074-E1083
- First steps toward harmonization of LC-MS/MS thyroglobulin assays.Clin Chem. 2016; 62: 297-299
- Implementing a reference measurement system for c-peptide: successes and lessons learned.Clin Chem. 2017; 63: 1447-1456
Prevention CfDCa. HoSt/VDSCP: standardization of measurement procedures. Laboratory Quality Assurance and Standardization Programs. 2017.
- Precisely wrong? Urinary fractionated metanephrines and peer-based laboratory proficiency testing.Clin Chem. 2005; 51 ([discussion 473–4]): 472-473
International Organization for Standardization (ISO). In vitro diagnostic medical devices – Measurement of quantities in biological samples – metrological traceability of values assigned to calibrators and control materials. ISO 17511:2003.
- Traceability, reference systems and result comparability.Clin Biochem Rev. 2007; 28: 97-104
Office-based Physician Electronic Health Record Adoption. Health IT Quick-Stat #50 2016; Health IT Quick-Stat #50. Available at: dashboard.healthit.gov/quickstats/pages/physician-ehr-adoption-trends.php. Accessed June 7, 2018.
- Directive 98/79/EC of the European parliament and of the council of 27 October 1998 on in vitro diagnostic medical devices.Official Journal of the European Communities. 1998; 41
US Food and Drug Administration (FDA), 2018. Clinical Laboratory Improvement Amendments (CLIA), Medical Devisces, IVD Regulatory Assistance. Available at: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm124105.htm. Accessed June 7, 2018.
- 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
- Harmonized reference ranges for circulating testosterone levels in men of four cohort studies in the United States and Europe.J Clin Endocrinol Metab. 2017; 102: 1161-1173
- Baseline assessment of 25-Hydroxyvitamin D assay performance: a Vitamin D standardization program (VDSP) interlaboratory comparison study.J AOAC Int. 2017; 100: 1244-1252
- The 3rd International Standard for serum IgE: international collaborative study to evaluate a candidate preparation.Clin Chem Lab Med. 2014; 52: 1283-1289
- Progress in standardizing and harmonizing thyroid function tests.Am J Clin Nutr. 2016; 104: 913s-917s
- 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
- Determination of serum cholesterol by a modification of the isotope dilution mass spectrometric definitive method.Anal Chem. 1989; 61: 1718-1723
- An international assessment of the metrological equivalence of higher-order measurement services for creatinine in serum.Anal Bioanal Chem. 2012; 403: 527-535
- NT-proBNP testing for diagnosis and short-term prognosis in acute destabilized heart failure: an international pooled analysis of 1256 patients: the International Collaborative of NT-proBNP Study.Eur Heart J. 2006; 27: 330-337
- A guide to harmonisation and standardisation of measurands determined by liquid chromatography–tandem mass spectrometry in routine clinical biochemistry.Clin Biochem Rev. 2012; 33: 123-132
- Current practices and challenges in the standardization and harmonization of clinical laboratory tests.Am J Clin Nutr. 2016; 104: 907s-912s
- Harmonization of laboratory testing—current achievements and future strategies.Clin Chim Acta. 2014; 432: 4-7
Centers for Disease Control and Prevention (CDC), 2018. Standardizing Hormone Measurements Program, Web site. Available at: https://www.cdc.gov/labstandards/pdf/hs/HoSt_Brochure.pdf. Accessed June 7, 2018.
Disclosures: A.L. Rockwood and M.S. Lowenthal have no conflicts to disclose. C. Bystrom is an employee of Cleveland HeartLab.