Moncrieffe, Danielle, Cox, Holly D., Carletta, Samantha, Becker, Jessica O., Thomas, Andreas, Eichner, Daniel, Ahrens, Brian, Thevis, Mario, Bowers, Larry D., Cowan, David A. and Hoofnagle, Andrew N. (2020). Inter-Laboratory Agreement of Insulin-like Growth Factor 1 Concentrations Measured Intact by Mass Spectrometry. Clin. Chem., 66 (4). S. 579 - 587. CARY: OXFORD UNIV PRESS INC. ISSN 1530-8561

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Abstract

BACKGROUND: Insulin-like growth factor-I (IGF-1) is measured mainly by immunoassay for the diagnosis and treatment of growth hormone (GH) disorders, and to detect misuse of GH in sport. Immunoassays often have insufficient inter-laboratory agreement, especially between commercial kits. Over the expected range of IGF-1 in blood (similar to 50-500 ng/mL), in an inter-laboratory study we previously established a measurement imprecision of 11% (%CV) for the digested protein analyzed by LC-MS. Measuring intact IGF-1 by LC-MS should be simpler. However, no inter-laboratory agreement has been published. METHODS: Intact and trypsin-digested IGF-1 in 32 serum samples from healthy volunteers and human growth hormone administration studies were analyzed by LC-MS using different instruments in five laboratories, as well as by immunoassay in a single laboratory. Another 100 samples were analyzed for IGF-1, both intact and after trypsin-digestion, in each laboratory by LC-MS. The statistical relationship between measurements and the imprecision of each assay group was assessed. RESULTS: An intra-laboratory variability of 2-4% CV was obtained. Inter-laboratory variability was greater at 14.5% CV. Orthogonal regression of intact versus trypsin-digestion methods (n= 646) gave a slope of 1.01 and intercept of 2.05 ng/mL. CONCLUSIONS: LC-MS measurements of IGF-1 by intact and trypsin-digestion methods are not statistically different and each is similar to immunoassay. The two LC-MS approaches may be used interchangeably or together to eliminate concerns regarding an immunoassay IGF-1 measurement. Because intact and digested IGF-1 measurements generally agreed within 20% of each other, we propose this as a criterion of assay acceptability.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Moncrieffe, DanielleUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cox, Holly D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Carletta, SamanthaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Becker, Jessica O.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Thomas, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eichner, DanielUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ahrens, BrianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Thevis, MarioUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bowers, Larry D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cowan, David A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hoofnagle, Andrew N.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-339268
DOI: 10.1093/clinchem/hvaa043
Journal or Publication Title: Clin. Chem.
Volume: 66
Number: 4
Page Range: S. 579 - 587
Date: 2020
Publisher: OXFORD UNIV PRESS INC
Place of Publication: CARY
ISSN: 1530-8561
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
FACTOR-I; IGF-I; HORMONE; QUANTIFICATION; SERUM; ASSAYS; LIMITSMultiple languages
Medical Laboratory TechnologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/33926

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