Oestradiol assays: fitness for purpose?

This version was published on 1 November 2009

Ann Clin Biochem 2009;46:441-456
© 2009 Association for Clinical Biochemistry


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Review Article

Jonathan G Middle1 and
John W Kane2

1 UK NEQAS, University Hospitals Birmingham NHS Foundation Trust, P.O. Box 3909, Birmingham B15 2UE;
2 Department of Clinical Biochemistry, Hope Hospital, Salford M6 8HD, UK

Corresponding author: Dr Jonathan Middle. Email: drjgmiddle{at}gmail.com

In this review we discuss the analytical inadequacies of oestradiolassays in relation to the clinical requirements for performingthem, and make recommendations for their improvement. The measurementof oestradiol can be requested in a number of clinical scenarios(precocious puberty, infertility, assisted conception, hormonereplacement therapy). The very wide dynamic range of oestradiolconcentrations is a huge challenge for routine assays, whichthey are unlikely to meet on theoretical as well as practicalgrounds. The EQA performance of oestradiol assays in terms oftrueness, comparability, recovery and analytical sensitivityleaves much to be desired and indicates that calibration iscompromised by poor analytical specificity. To make oestradiolassays fit for purpose requires concerted action by all stakeholdersto define analytical quality specifications for the variousclinical scenarios involved, and then to encourage concertedaction by the diagnostic industry to use the steroid referencemeasurement system to improve specificity, trueness and traceability.

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