title: Human thyroglobulin reference material (CRM 457). 2nd Part: Physicochemical characterization and certification.
abstract: This report describes the characterization of a purified human thyroglobulin (Tg) reference material, and details the procedures used in its certification. The purified Tg is intended to be used as a primary reference material to establish calibration of working serum based reference material for immunoassay procedures. The programme involved the participation of 15 European laboratories and one laboratory from the United States. The physicochemical characterization showed by polyacrylamide gel electrophoresis and immunoblotting that the purified Tg had for the major part the expected molecular size of 660 kDa with traces of lower molecular forms. The amino acid composition was close to that demonstrated for the cDNA and the content of iodine was in keeping with a moderately to highly iodinated Tg. The mass concentration in reference material RM 457 is certified to be (0.324 +/- 0.018) g/L on the basis of protein determined by the Lowry method and supported by nitrogen determination, absorbance measurement, and amino acid analysis. This reference material is considered the first step towards decreasing the interlaboratory variability between Tg methods of measurement.
authors.affiliation: Department of Medicine, National University Hospital, Copenhagen, Denmark.
authors.forename: U
authors.initials: U
authors.lastname: Feldt-Rasmussen
authors.forename: C
authors.initials: C
authors.lastname: Profilis
authors.forename: E
authors.initials: E
authors.lastname: Colinet
authors.forename: E
authors.initials: E
authors.lastname: Black
authors.forename: H
authors.initials: H
authors.lastname: Bornet
authors.forename: P
authors.initials: P
authors.lastname: Bourdoux
authors.forename: P
authors.initials: P
authors.lastname: Carayon
authors.forename: U B
authors.initials: UB
authors.lastname: Ericsson
authors.forename: D A
authors.initials: DA
authors.lastname: Koutras
authors.forename: L
authors.initials: L
authors.lastname: Lamas de Leon
authors.forename: P
authors.initials: P
authors.lastname: DeNayer
authors.forename: F
authors.initials: F
authors.lastname: Pacini
authors.forename: G
authors.initials: G
authors.lastname: Palumbo
authors.forename: A
authors.initials: A
authors.lastname: Santos
authors.forename: M
authors.initials: M
authors.lastname: Schlumberger
authors.forename: C
authors.initials: C
authors.lastname: Seidel
authors.forename: A J
authors.initials: AJ
authors.lastname: Van Herle
authors.forename: J J
authors.initials: JJ
authors.lastname: DeVijlder
mesh_terms: D000596:Amino Acids / Q000032:analysis; D000704:Analysis of Variance; D002568:Certification; D055598:Chemical Phenomena; D002627:Chemistry, Physical; D006801:Humans; D007118:Immunoassay / Q000295:instrumentation*; D007455:Iodine / Q000032:analysis; D009584:Nitrogen / Q000032:analysis; D009994:Osmolar Concentration; D012015:Reference Standards; D013954:Thyroglobulin / Q000097:blood* / Q000737:chemistry
chemical_list: D000596:Amino Acids; D013954:Thyroglobulin; D007455:Iodine; D009584:Nitrogen