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

Area of Science:

• Endocrinology
• Clinical Chemistry
• Analytical Chemistry

Background:

• D4-androstenedione (D4ASD) is a key intermediate in androgen biosynthesis.
• Accurate D4ASD measurement is crucial for diagnosing androgenic hyperproduction disorders.
• Existing quantification methods, particularly immunoassays, face challenges with steroid cross-reactivity.

Purpose of the Study:

• To evaluate the analytical performance of a new, fully automated D4ASD assay from Roche®.
• To compare the Roche® D4ASD assay with radioimmunoassay (RIA) and liquid chromatography-tandem mass spectrometry (LC-MS/MS).

Main Methods:

• Assessment of repeatability and intermediate precision for the D4ASD Roche® assay.
• Comparison of the Roche® assay against RIA and LC-MS/MS methods.
• Evaluation based on the RICOS standard and correlation analysis (slope, y-intercept).

Main Results:

• The D4ASD Roche® assay demonstrated acceptable repeatability and intermediate precision (CV ≤ 7.9%) per the RICOS standard.
• The assay showed good correlation with reference methods, with acceptable 95% confidence intervals for slope and y-intercept.
• Analytical performance criteria, including imprecision and trueness, met predefined acceptance limits.

Conclusions:

• The Roche® automated assay for D4-androstenedione (D4ASD) exhibits acceptable analytical performance.
• The method provides reliable results with intermediate imprecision and trueness within acceptable limits.
• This assay presents a viable option for D4ASD quantification in clinical diagnostics.