Sugammadex interference with serum progesterone measurement: an in-vitro study.

Abstract

Sugammadex may interfere with serum progesterone immunoassays, potentially rendering measured concentrations and resulting recommendations unreliable. We investigated the effect of a range of sugammadex concentrations on serum progesterone concentrations in samples from pre-menopausal female volunteers. Samples were spiked with sugammadex concentrations (15-120 μM), corresponding to clinical doses between 2 mg.kg^-1 and 19 mg.kg^-1. Total progesterone concentrations in each sample were determined using the routine electrochemiluminescence immunoassay method. A subgroup of 15 samples underwent further testing using liquid chromatography-tandem mass spectroscopy, comparing baseline with sugammadex 120 μM. Thirty-five participants provided blood samples. Increasing concentrations of sugammadex were associated with lower measured serum progesterone, with an approximate 10% reduction with each doubling of sugammadex concentration (F(2,30) = 4.86, p = 0.015). Overall, progesterone concentrations decreased by a mean (SD) of 34.6% (12.4%) between control samples and those spiked with sugammadex 120 μM (p = 0.015). In contrast, liquid chromatography-tandem mass spectroscopy showed no statistically significant biochemical change in progesterone concentrations between baseline and sugammadex 120 μM. Sugammadex produced a dose-dependent reduction in the progesterone concentrations when measured by immunoassay techniques, but not by liquid chromatography-tandem mass spectroscopy. This suggests that an immunoassay interference occurs across clinically relevant doses. Progesterone results from routine laboratory testing should be interpreted with caution in the presence of sugammadex.