ArticleJournal of medical biochemistry2026
Application of the latest CLSI EP guidelines in light-initiated chemiluminescent assay for testosterone.
Article in Journal of medical biochemistry, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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6 authors.
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Abstract
Background: A commercial light-initiated chemiluminescent assay (LiCA) for testosterone (T) measurement was developed. This study comprehensively evaluated the analytical performance of LiCA-T following the Clinical and Laboratory Standards Institute (CLSI) Evaluation Protocols (EP) series guidelines. Methods: From July 1st 2023, both the manufacturer and clinical end-users conducted rigorous performance evaluations in accordance with CLSI EP guidelines. Assessment included precision, linearity, accuracy/trueness, detection limits, and interference testing using collected clinical samples. All the tests were carried out using LiCA® 800 (Chemclin, Beijing, China), and the reagent of lot 2202. Results: Manufacturer evaluations demonstrated excellent assay performance: repeatability (1.41-4.39%), intermediate imprecision (1.62-7.29%), and reproducibility (1.62-7.22%). The method showed linearity across 0.10-16.64 ng/mL (ADL=10%). Method comparison with MS reference yielded a limit of agreement (LoA) of -19.5% to 14.4%, with ≤10.00% bias at medical decision points. Sensitivity parameters included: LoB (0.041 ng/mL), LoD (0.049 ng/mL), and LoQ (0.060 ng/mL at 20% imprecision). The assay demonstrated robust interference resistance against haemoglobin (2 mg/mL), biotin (20 ng/mL), triglyceride (3 mg/mL), and bilirubin (0.157 mg/mL). All manufacturer claims were successfully verified by independent clinical end-user testing. Conclusions: The LiCA-T assay satisfies all performance criteria specified in CLSI latest EP guidelines (including EP06-Ed2 and EP07-Ed3), demonstrating reliable analytical performance across all critical validation parameters for clinical testosterone measurement.
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