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International Standards for human prolactin: calibration by international collaborative study
D Schulster1, R E Gaines Das, S L Jeffcoate
1National Institute for Biological Standards and Control, Potters Bar, Herts.
The Journal of Endocrinology
|April 1, 1989
Summary
Two new international standards for human prolactin were established to ensure accurate serum prolactin measurement. These standards, designated Second and Third International Standards, maintain assay continuity for reliable clinical assessments.
Area of Science:
- Endocrinology
- Biotechnology
- Assay Development
Background:
- Accurate quantification of human prolactin (hPRL) is crucial for diagnosing various endocrine disorders.
- Previous international standards for hPRL required re-evaluation to ensure continued accuracy and comparability across laboratories.
Purpose of the Study:
- To assess the suitability of three ampouled preparations of purified human prolactin for use as international standards.
- To establish new international standards for the reliable estimation of human prolactin in serum.
Main Methods:
- Collaborative study involving 20 laboratories in eight countries.
- Utilized bioassays (pigeon crop sac, NB2 cell), radioreceptor assays, and radioimmunoassays.
- Physicochemical analysis was performed to assess preparation characteristics.
Main Results:
- Physicochemical analysis indicated similarity among the three preparations, though minor contaminants/variants were present.
- Immunoassays showed no major differences, but one radioreceptor assay identified a difference in one preparation.
- The World Health Organization's Expert Committee on Biological Standardization established 83/562 as the Second IS and 84/500 as the Third IS for prolactin.
Conclusions:
- Preparations 83/562 and 84/500 were established as the Second and Third International Standards for human prolactin, respectively.
- A unitage of 0.053 IU (53 mIU) per ampoule was assigned to maintain continuity with the previous international reference preparation.
- These new standards facilitate consistent and accurate measurement of human prolactin in clinical settings.