Definition and Measurement of Follicle Stimulating Hormone
Matthew P. Rose,
Rose E. Gaines Das and
Adam H. Balen
Division of Endocrinology (M.P.R.) and Informatics Laboratory
(R.E.G.D.), National Institute for Biological Standards and Control,
South Mimms, Potters Bar, Hertfordshire EN6 3QG; and The General
Infirmary at Leeds (A.H.B.), United Leeds Teaching Hospitals National
Health Service Trust, Belmont Grove, Leeds, West Yorkshire LS2 9NS,
United Kingdom
FSH has a key role in the development and function of the reproductive
systemand is widely used both diagnostically and therapeutically in
developmentaland reproductive medicine. The accurate measurement of
FSH levels,in patients for diagnosis and monitoring and in therapeutic
preparationsfor clinical use, is essential for safe and successful
treatment.Historically, FSH was defined on the basis of classical
in vivoendocrine activity, and early therapeutic
preparations werecalibrated using in vivo bioassays.
There was early recognitionthat reference preparations were required
for calibration ifthe results from different laboratories were to be
comparable.In response to the perceived need, the World Health
Organizationestablished the first standard for such preparations
in 1959.Subsequent developments in biotechnology have led to
recognitionthat there is no single molecule that can be uniquely
definedas FSH, and that FSH can induce a range of biological
activities.Several highly purified standards for FSH are now
available,but discontinuity and heterogeneity of estimates of FSH
activityin terms of these standards made using in vitro
assays and bindingassays have been noted. It is thus essential
that any measurementof FSH include specification both of the standard
with whichthe measured FSH is compared and the assay method used for
thatcomparison.
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