A Standardised Multicentre Procedure for Plasma Gonadotrophin Radioimmunoassay

Abstract

A radioimmunoassay method for the assay of luteinising hormone (LH) and follicle-stimulating hormone (FSH) in serum/plasma has been designed for use in laboratories of varying expertise in the United Kingdom. The major sources of experimental error leading to poor within-laboratory performance and between-laboratory comparability were identified: quality of tracer, use of calibration standards, and separation procedure. A simple rugged kit was designed which was extensively tested first in our laboratory and then in a small multi-centre field trial before being made available. It is now used routinely by 26 health service and research laboratories. The working range of the assays is 1–50 IU/l (LH) and 0·3–16 IU/l (FSH). The between-batch reproducibility was 5–11 % (CV) over the dose range 4·8–18 IU/l (LH) and 1·6–15 IU/l (FSH).