ANALYTICAL AND CLINICAL-EVALUATION OF THE IMMULITE(R) ESTRADIOL ASSAYIN SERUM FROM PATIENTS UNDERGOING IN-VITRO FERTILIZATION - ESTRADIOL INCREASE IN MATURE FOLLICLES

We examined an immunoassay for estradiol (E2) on the Immulite(R)-an au tomated, random access chemiluminescent immunoassay system-to determin e its accuracy and precision required for in vitro fertilization (IVF) studies. The assay, which has a reportable range from 73 to 7300 pmol /L, demonstrated good linearity under dilution, a detection limit of 4 4 pmol/L, and interassay CVs of 12.6% and 7.6% at 466 and 6164 pmol/L, respectively. In a retrospective analysis of 545 serum samples, the a ssay showed adequate agreement with an antibody-coated-tube RIA. The t wo E2 assays showed good agreement, even on samples from patients rece iving a variety of different estrogen replacement therapies. Longitudi nal studies of individual IVF cycles showed good parallelism between t he automated system and the RIA, and results by the automated assay co rrelated well with the total number of follicles.