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Abstract INTRODUCTION:
Accurate quantitation of low-level steroids in clinical research necessitates sample preparation methods that are both efficient and highly reproducible. Supported Liquid Extraction (SLE) offers a streamlined alternative to Solid Phase Extraction (SPE), particularly in high-throughput laboratories, due to its simplified workflow and reduced need for labor-intensive method development. This study evaluates the performance of the new synthetic Strata™ SE SLE product in two critical areas: batch-to-batch reproducibility and comparative extraction efficiency against other commercial SLE products.
A rigorous evaluation of batch-to-batch reproducibility was conducted prior to product release, recognizing that variability between production lots can lead to inconsistent analyte recovery, matrix effects, or background contamination—factors that can compromise data integrity in clinical research. Additionally, a comparative analysis was performed using a panel of eleven clinically relevant steroids with low limit of detection (LOD) requirements, reflecting their importance in disease-state research. A key focus of this study was to develop a sustainable extraction method by avoiding halogenated solvents such as dichloromethane, which are traditionally used in SLE but pose environmental and regulatory concerns.
METHODS:
Eleven steroid analytes were extracted from human serum at LOD, 2×LOD, and 5×LOD concentrations using Strata SE SLE. Ethyl acetate, a non-halogenated solvent, was used as the primary eluent and compared with dichloromethane to assess performance. Batch-to-batch reproducibility was evaluated across three independently manufactured lots of Strata SE. Comparative performance was assessed against Novum Pro and a leading competitor SLE product using both eluents. LC-MS/MS analysis was conducted using an Agilent® 1290 Infinity LC system coupled with a SCIEX® 7500 Triple Quad MS.
RESULTS:
Strata SE demonstrated excellent batch-to-batch reproducibility, with recovery values ranging from 76–112% and inter-batch %CVs consistently below 20%. In comparative studies, Strata SE using ethyl acetate achieved superior recovery (73–118% at LOD) and cleaner extracts than both Novum Pro and the competitor SLE. Matrix effects and process efficiency were also favorable. Importantly, Strata SE eliminated the need for dichloromethane, aligning with recent U.S. EPA restrictions and supporting laboratories' sustainability initiatives.
CONCLUSION:
The new Strata SE SLE platform delivers high-quality, reproducible extraction of low-level steroids from complex biological matrices using a sustainable, non-halogenated solvent. Its performance not only meets but exceeds that of established commercial SLE products, offering superior recovery, reduced matrix interference, and minimal background contamination. The demonstrated batch-to-batch consistency further reinforces its reliability for routine clinical research applications. By enabling laboratories to transition away from chlorinated solvents without compromising analytical performance, Strata SE SLE represents a forward-looking solution that supports both scientific excellence and environmental responsibility.
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= Discovery stage. (53.14%, 2025)
= Translation stage. (22.33%, 2025)
= Clinically available. (24.53%, 2025)
