FOLLICLE-STIMULATING-HORMONE - INTERNATIONAL STANDARDS AND REFERENCE PREPARATIONS FOR THE CALIBRATION OF IMMUNOASSAYS AND BIOASSAYS

Follicle stimulating hormone is a dimeric glycoprotein hormone which i s used widely in reproductive and developmental medicine both as a dia gnostic analyte and as a therapeutic product. It is therefore a good e xample of a clinically important heterogeneous material for which a nu mber of different assay methodologies have been developed. Immunoassay s for follicle stimulating hormone (FSH) are used in the diagnosis of disorders of reproduction and development, whereas in vivo bioassays a re used for calibration of therapeutic preparations. Different immunoa ssay systems, based on different formats, exhibit variability in their estimates of activity of FSH which arises from different specificitie s of antibodies for different forms of FSH which are encountered. In o rder to minimise between assay variation and to enable better between laboratory comparisons the World Health Organisation (WHO) has issued a series of ampouled preparations of FSH. The availability of these ma terials has been reviewed previously but on the completion of a recent collaborative study to evaluate candidate standards for rDNA-derived FSH and highly purified urinary FSH (urofollitropin) it is now appropr iate to review the current status of these standards and to discuss th e future of standardisation for FSH in particular and where appropriat e to make reference to other materials. (C) 1998 Elsevier Science B.V. All rights reserved.