Multicenter evaluation of new enzyme-linked immunoassays of follitropin and lutropin in serum or plasma

Clin Chem. 1991 Jul;37(7):1257-63.

Abstract

Results from a multicenter evaluation of two new enzyme-linked immunosorbent assays [Enzymun-Test for follitropin (FSH) and lutropin (LH)] are presented and compared with results from 11 other commercial immunoassays, radioactive as well as nonradioactive. Enzymun-Test FSH and LH assays are suitable for automated systems and manual applications. The tests were reproducible (CV less than 5%), highly specific, and sensitive enough (less than 0.5 int. unit/L) to measure the hormones directly in almost all patients' samples, except for LH measurements in prepubertal children. We did not find interference by heterophilic antibodies or other factors. A comparison of assays for FSH found very good agreement among all modern two-site assays; competitive immunoassays almost invariably yielded systematically lower results for FSH, probably because of the heterogeneity of the International Reference Preparation (2nd IRP FSH, 78/549). For LH also we found good agreement, with no systematic differences among the various reagents. Guidelines for reference values with the new reagents are given.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study

MeSH terms

  • Adult
  • Child
  • Cross Reactions
  • Enzyme-Linked Immunosorbent Assay*
  • Female
  • Follicle Stimulating Hormone / blood*
  • Humans
  • Luteinizing Hormone / blood*
  • Male
  • Pituitary Hormones / metabolism
  • Pregnancy
  • Reagent Kits, Diagnostic
  • Reference Standards
  • Reference Values
  • Reproducibility of Results

Substances

  • Pituitary Hormones
  • Reagent Kits, Diagnostic
  • Luteinizing Hormone
  • Follicle Stimulating Hormone