BIOASSAY CHARACTERISTICS OF INDIVIDUAL URINARY GONADOTROPHIN EXTRACTS
ABSTRACT A reference standard is widely sought for use in the quantitative bioassay of pituitary gonadotrophin recovered from urine. The biologic similarity of pooled urinary extracts obtained from large numbers of subjects, utilizing groups of different age and sex, preparing and assaying the materials by varying techniques in different parts of the world, has lead to a general acceptance of such preparations as international gonadotrophin reference standards. In the present study, however, the extract of pooled urine from a small number of young women is shown to produce a significantly different bioassay response from that of the reference materials. Gonadotrophins of individual subjects likewise varied from the multiple subject standards in many instances. The cause of these differences is thought to be due to the modifying influence of non-hormonal substances extracted from urine with the gonadotrophin and not necessarily to variations in the gonadotrophins themselves. Such modifying factors might have similar effects in a comparative assay of pooled extracts contributed by many subjects, but produce significant variations when material from individual subjects is compared. It is concluded that the expression of potency of a gonadotrophic extract in terms of pooled reference material to which it is not essentially similar may diminish rather than enhance the validity of the assay.