Assessment of the Androstenedione Assay on a Roche Analytical Platform and Comparison with Different Methods

Background: D4-androstenedione (D4ASD) is an intermediate hormone of androgen biosynthesis by the gonads and the adrenal glands. The interest in D4ASD concentration assessment resides in diagnostics of androgenic hy-perproduction pathologies. Currently, many D4ASD quantification methods are available on the market including immunological methods that remain problematic due to the possible cross-reactivity with endogenous or exoge-nous steroids.Methods: Recently Roche (R) launched a new fully automated instrument for the measurement of D4ASD concentra-tion. In this paper, the criteria of analytical performance (repeatability and intermediate precision) of the D4ASD Roche (R) assay were assessed and compared with 2 different methods including a radioimmunoassay (RIA) as well as a liquid chromatography tandem mass spectrometry (LC-MS/MS) method.Results: Repeatability and intermediate precision of the D4ASD Roche (R) were acceptable according to the prede-fined RICOS standard (CV <= 7.9%) and the assay showed a good correlation with other assays considering the 95% CI obtained for the slope and the y-intercept.Conclusions: This method demonstrates acceptable criteria of analytical performance with an intermediate impre-cision and a trueness within the fixed acceptance limits.(Clin. Lab. 2023;69:xx-xx. DOI: 10.7754/Clin.Lab.2022.220538)