{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,18]],"date-time":"2026-03-18T01:30:53Z","timestamp":1773797453910,"version":"3.50.1"},"reference-count":27,"publisher":"Centre for Evaluation in Education and Science (CEON\/CEES)","issue":"3","license":[{"start":{"date-parts":[[2026,1,1]],"date-time":"2026-01-01T00:00:00Z","timestamp":1767225600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/BY\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Med Biochemistry"],"published-print":{"date-parts":[[2026]]},"abstract":"<jats:p>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\u00ae 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 \u226410.00% 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.<\/jats:p>","DOI":"10.5937\/jomb0-58894","type":"journal-article","created":{"date-parts":[[2025,9,8]],"date-time":"2025-09-08T07:24:07Z","timestamp":1757316247000},"page":"680-689","source":"Crossref","is-referenced-by-count":0,"title":["Application of the latest CLSI EP guidelines in light-initiated chemiluminescent assay for testosterone"],"prefix":"10.5937","volume":"45","author":[{"given":"Ai","family":"Liang","sequence":"first","affiliation":[{"name":"Women & Infants Hospital of Zhengzhou, Department of Laboratory Science, Zhengzhou, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cao","family":"Xiao-Jing","sequence":"additional","affiliation":[{"name":"The Second Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Geriatric Diseases, Beijing, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ren","family":"Xin-Xin","sequence":"additional","affiliation":[{"name":"Chemclin Diagnostics Co., Ltd. Standardisation & Performance Evaluation Laboratory, Beijing, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kang","family":"Lan","sequence":"additional","affiliation":[{"name":"Chemclin Diagnostics Co., Ltd. Standardisation & Performance Evaluation Laboratory, Beijing, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhang","family":"Dan","sequence":"additional","affiliation":[{"name":"Chemclin Diagnostics Co., Ltd. Standardisation & Performance Evaluation Laboratory, Beijing, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xin","family":"Chang","sequence":"additional","affiliation":[{"name":"Chemclin Diagnostics Co., Ltd. Standardisation & Performance Evaluation Laboratory, Beijing, China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"3964","reference":[{"key":"ref1","unstructured":"CLSI, Interference Testing in Clinical Chemistry. 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