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Human Reproduction 2007 22(12):3204-3209; doi:10.1093/humrep/dem322
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© The Author 2007. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Accuracy and reproducibility of automated estradiol-17beta and progesterone assays using native serum samples: results obtained in the Belgian external assessment scheme

Wim Coucke1,4, Nicole Devleeschouwer1, Jean-Claude Libeer1, Johan Schiettecatte2, Manou Martin3 and Johan Smitz2

1 Department of Clinical Biology, Scientific Institute of Public Health, Juliette Wytsmanstraat 14, 1050 Brussels, Belgium 2 Laboratory of Clinical Chemistry and Radioimmunology, UZ Brussel, 1090 Brussels, Belgium 3 UZA Department ofHormonology, Therapeutic Drug Monitoring and Clinical Toxicology, University Hospital Antwerp, 2650 Edegem, Belgium

4Correspondence address. E-mail: wim.coucke{at}iph.fgov.be

BACKGROUND: In 2005, a special survey in the Belgian External Quality Assessment focused on the performance of six automated immunoassay analysers most frequently used in Belgium for estradiol-17beta (E2) and progesterone. Results obtained were compared with values determined by reference method, isotope dilution–gas chromatograph/mass spectrometry (ID–GC/MS).

METHODS: Five fresh frozen serum samples, without additives, from single donors and three pools from pregnant women were distributed to all registered Belgian laboratories. Total variation, bias, linear relationship within the reported range and linear regression were investigated.

RESULTS: Inter-laboratory coefficients of variation ranged from 4 to 49% for E2 and from 6 to 45% for progesterone. Bias ranged from –26 to 239% for E2 and from –23 to 81% for progesterone. Several systems showed an upward bias for one particular sample of at least 25%. Weighted linear regression showed overall bias ranging from –8% to 32% for E2 and from 7% to 41% for progesterone.

CONCLUSIONS: Few automated methods succeed in having an excellent reproducibility for E2 and progesterone. Given the high bias values it is suggested that, for performance testing, results be compared whenever possible with a reference method. The linear relationship as assessed by comparing results with those obtained by ID–GC/MS using samples from different donors was not assured for most methods.

Key words: immunoassay/estradiol/progesterone/external quality assessment/automation

Submitted on May 2, 2007; resubmitted on September 4, 2007; accepted on September 14, 2007.


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