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Clinical Chemistry 37: 540-546, 1991;
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Clinical Chemistry, Vol 37, 540-546, Copyright © 1991 by American Association for Clinical Chemistry

Development, validation, and certification by isotope dilution gas chromatography-mass spectrometry of lyophilized human serum reference materials for cortisol (CRM 192 and 193) and progesterone (CRM 347 and 348)

L Thienpont, L Siekmann, A Lawson, E Colinet and A De Leenheer
Laboratoria voor Medische Biochemie en voor Klinische Analyse, RUG, Ghent, Belgium.

The Community Bureau of Reference of the European Communities has produced four batches of lyophilized serum Certified Reference Materials, two for cortisol (CRM 192 and 193) and two for progesterone (CRM 347 and 348). For cortisol, one of the pools consisted of serum from healthy blood donors, whereas the second batch was supplemented with pure cortisol. The progesterone Reference Materials contained only endogenous hormone concentrations. Assessment of vial-to-vial variability in the cortisol and progesterone concentrations showed no between-sample inhomogeneity, and the materials were stable. The quality of the materials was therefore considered sufficient for certification of the values for the cortisol and progesterone concentrations by a collaborative study involving several laboratories from the European Communities, using isotope dilution gas chromatography-mass spectrometry. Inaccuracy in reconstitution of the lyophilized materials was less than 0.3%; imprecision of sampling was less than 0.2%. For determinations of cortisol and progesterone concentrations, the mean within-laboratory coefficients of variation (CVs) were 1.76% (CRM 192), 1.19% (CRM 193), 1.64% (CRM 347), and 1.75% (CRM 348). The between-laboratory CVs were greater: CRM 192, 1.79%; CRM 193, 1.48%; CRM 347, 2.08%; and CRM 348, 2.16%. The concentrations in the reconstituted Reference Materials were certified to be 273 nmol/L in CRM 192 and 763 nmol/L in CRM 193 for cortisol and 10.13 nmol/L in CRM 347 and 40.3 nmol/L in CRM 348 for progesterone. Uncertainties at the 0.95 confidence level--6 (CRM 192), 14 (CRM 193), 0.21 (CRM 347), and 1.0 nmol/L (CRM 348)--were considered compatible with the intended use of the materials.


The following articles in journals at HighWire Press have cited this article:


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 Ann Clin BiochemHome page
L. Wood, D. H Ducroq, H. L Fraser, S. Gillingwater, C. Evans, A. J Pickett, D. W Rees, R. John, and A. Turkes
Measurement of urinary free cortisol by tandem mass spectrometry and comparison with results obtained by gas chromatography-mass spectrometry and two commercial immunoassays
Ann Clin Biochem, July 1, 2008; 45(4): 380 - 388.
[Abstract] [Full Text] [PDF]


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Copyright © 1991 by the American Association for Clinical Chemistry.