{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T13:45:42Z","timestamp":1791812742688,"version":"4.3.4"},"reference-count":39,"publisher":"Walter de Gruyter GmbH","funder":[{"name":"Hangzhou Biomedical and Health Industry Developing and Supporting Special Projects in Science and Technology","award":["2024WJC043"],"award-info":[{"award-number":["2024WJC043"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec id=\"j_cclm-2026-0886_abs_001\">\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To evaluate the analytical performance and clinical classification value of a novel sandwich testosterone immunoassay, particularly for biochemical testosterone elevation in women and deficiency in male hemodialysis patients, using LC\u2013MS\/MS as the reference method.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2026-0886_abs_002\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A total of 387 residual clinical serum samples were compared using Mindray TESTO, Siemens TSTII, and liquid chromatography\u2013tandem mass spectrometry (LC\u2013MS\/MS). Among these, 226 had testosterone concentrations &lt;1.0\u202fng\/mL, and 133\u00a0reproductive-age women were evaluated for biochemical hyperandrogenism classification. An additional 119 hemodialysis samples (94 men, 25 women) were assessed, with the 94 men evaluated for biochemical testosterone deficiency classification. Analyses included Passing\u2013Bablok regression, Bland\u2013Altman analysis, and independent imprecision, linearity, and interference studies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2026-0886_abs_003\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The Mindray TESTO assay showed total CVs of 1.68\u20132.71\u202f% and good linearity (r=0.9997). Cross-reactivity was generally low, although phenylbutazone produced biases exceeding \u00b110\u202f%. Both immunoassays correlated strongly with LC\u2013MS\/MS, with Mindray TESTO showing higher correlation and narrower limits of agreement in low-concentration samples (r=0.9603 vs. 0.8920). In women of reproductive age, Mindray TESTO demonstrated higher sensitivity (88.89 vs. 11.11\u202f%) and \u03ba agreement (0.784 vs. 0.189) for biochemical hyperandrogenism classification. In male hemodialysis patients, it achieved higher accuracy (94.68 vs. 88.30\u202f%) and \u03ba agreement (0.838 vs. 0.680) for biochemical testosterone deficiency classification. The ROC AUCs did not differ significantly (0.966 vs. 0.956; p=0.2776).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2026-0886_abs_004\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The novel sandwich immunoassay showed improved agreement with LC\u2013MS\/MS at low testosterone concentrations and favorable performance in classifying biochemical testosterone elevation and deficiency.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1515\/cclm-2026-0886","type":"journal-article","created":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T14:35:53Z","timestamp":1791470153000},"source":"Crossref","is-referenced-by-count":0,"title":["Analytical performance and clinical classification value of a novel sandwich immunoassay for total testosterone measurement in low-concentration and hemodialysis populations"],"prefix":"10.1515","author":[{"given":"He","family":"Shi","sequence":"first","affiliation":[{"name":"Department of Clinical Laboratory , Hangzhou Traditional Chinese Medicine Hospital Affiliated to Zhejiang Chinese Medical University , Hangzhou , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5833-1932","authenticated-orcid":false,"given":"Huimei","family":"Wei","sequence":"additional","affiliation":[{"name":"Shenzhen Mindray Bio-Medical Electronics Co. Ltd. , Shenzhen , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shuaiwei","family":"Han","sequence":"additional","affiliation":[{"name":"Hangzhou Medical College , Hangzhou , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Minjie","family":"Liu","sequence":"additional","affiliation":[{"name":"ShuLan (Hangzhou) Hospital , Hangzhou , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bingjie","family":"Shui","sequence":"additional","affiliation":[{"name":"Department of Clinical Laboratory , Hangzhou Traditional Chinese Medicine Hospital Affiliated to Zhejiang Chinese Medical University , Hangzhou , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jijuan","family":"Gao","sequence":"additional","affiliation":[{"name":"Department of Clinical Laboratory , Hangzhou Traditional Chinese Medicine Hospital Affiliated to Zhejiang Chinese Medical University , Hangzhou , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu","family":"Luo","sequence":"additional","affiliation":[{"name":"Department of Clinical Laboratory , Hangzhou Traditional Chinese Medicine Hospital Affiliated to Zhejiang Chinese Medical University , Hangzhou , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Huaying","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Clinical Laboratory , Hangzhou Traditional Chinese Medicine Hospital Affiliated to Zhejiang Chinese Medical University , Hangzhou , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Huiai","family":"Lu","sequence":"additional","affiliation":[{"name":"Department of Clinical Laboratory , Hangzhou Traditional Chinese Medicine Hospital Affiliated to Zhejiang Chinese Medical University , Hangzhou , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pengcheng","family":"Tong","sequence":"additional","affiliation":[{"name":"Department of Clinical Laboratory , Hangzhou Traditional Chinese Medicine Hospital Affiliated to Zhejiang Chinese Medical University , Hangzhou , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Huan","family":"He","sequence":"additional","affiliation":[{"name":"Shenzhen Mindray Bio-Medical Electronics Co. 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