WHO Expert Committee on Biological Standardization. Twenty sixth report

Abstract

This latest report of the WHO Expert Committee on Biological Standardization is mainly concerned with the standardization of hormone preparations. One international standard and 13 international reference preparations were established by the Committee and 16 international units of potency were defined. The international standard is for human urinary FSH and LH(ICSH) for bioassay, which replaces the second international reference preparation of HMG. Several other glycoprotein hormones were considered and international reference preparations of the following substances were established: human chorionic gonadotrophin (HCG) and its subunits for immunoassay, human pitiutary gonadotrophins (FSH and LH(ICSH)) for bioassay, human pituitary LH(ICSH) for immunoassay, and human thyrotrophin (TSH) for immunoassay. Other hormones for which international reference preparations were established were porcine and salmon calcitonins fo bioassay, human renin, 2 preparations of bovine parathyroid hormone (one for bioassay, the other for immunoassay), and 2 other hormone preparations for immunoassay, human insulin and porcine glucagon; international standards for these substances for bioassay have already been established. The Committee asked that a number of other hormones be considered for standardization. These are all materials of human origin and include calcitonin, ACTH, pituitary FSH and LH (ICSH), vasopressin, prolactin, placental lactogen, some gastrointestinal hormones, parathyroid hormone, various hormone components (subunits of glycoprotein hormones FSH, LH(ICSH) and TSH), insulin C peptide, neurophysins) and some hormone releasing and hormone inhibiting substances (for TSH, growth hormone and gonadotrophins). Most of these are intended to serve as reference preparations for immunoassay. A number of recommendations adopted by the Committee are embodied in 2 annexes to the report. The first annex, which gives recommendations for the assessment of assay sytems, provides guidelines to national authorities and others for the formulation of requirements for reagents used in immunoassays and cytochemical bioassays; an important part of this annex deals wih assay kits used for pregnancy testing. The second annex deals with the development of national assay systems for hormones (and other substances) of health importance which should be developed within community health care services. A third annex lists the sets of requirements for biological substances and other sets of recommendations (including the above annexes), adopted by successive WHO expert committies on biological standardization and other expert groups. Lists of biological substances that are available as WHO international standards and international reference preparations are now published separately from reports of the expert committees; and an up to date list is in course of preparation.