{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T12:51:41Z","timestamp":1792068701447,"version":"4.4.0"},"reference-count":40,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T00:00:00Z","timestamp":1790726400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Clin Biochem"],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The concentration of 25-hydroxyvitamin D [25-(OH)D] is used to evaluate vitamin D status. Persistent discrepancies between chemiluminescent immunoassays (CLIAs) and liquid chromatography-tandem mass spectrometry (LC-MS\/MS) continue to challenge clinical laboratories. To investigate the single epitope meta-sandwich (SEMS) immunoassay from Mindray, we assessed the analytical performance of the VD-T II assay and established reference intervals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We evaluated detection limits, precision, linearity, and cross-reactivity following the American Clinical and Laboratory Standards Institute (CLSI) protocols. A total of 118 selected serum samples were measured using the Mindray VD-T II assay (CLIA), and the results were compared with those obtained by LC-MS\/MS and three other automated 25-(OH)D assays (Roche, Abbott, Snibe). Additionally, season-stratified 95% reference intervals for adults and age-specific 95% reference intervals for children were established using the VD-T II assay based on samples from 1402 healthy individuals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The limits of blank (LoB), detection (LoD), and quantitation (LoQ) all met the claimed specifications. Within-run and within-laboratory precision coefficients of variation (%CV) for the VD-T II assay ranged from 1.64% to 2.36% and from 3.08% to 6.32%, respectively. Good linearity was observed over the linear range of 3.00\u2013150.00\u00a0ng\/mL. Cross-reactivity with analogs was acceptable. The correlation coefficient between VD-T II and LC-MS\/MS was 0.963, the highest among the assays tested. In adults, the 95% reference intervals were 7.86\u201348.56\u00a0ng\/mL in summer and 6.28\u201343.34\u00a0ng\/mL in winter. In children, the 95% reference intervals were 3.76\u201343.34\u00a0ng\/mL for those &lt;1\u00a0year old, 6.56\u201350.47\u00a0ng\/mL for those 1\u201313\u00a0years old, and 4.66\u201329.22\u00a0ng\/mL for those 14\u201318\u00a0years old.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The Mindray VD-T II assay demonstrates robust analytical performance and good agreement with LC-MS\/MS, supporting its use as a suitable method for routine total 25-(OH)D testing.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/00045632261497590","type":"journal-article","created":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T15:50:48Z","timestamp":1790783448000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Analytical performance of a single epitope meta-sandwich total 25-hydroxyvitamin D immunoassay and establishment of reference intervals in a Chinese population"],"prefix":"10.1177","author":[{"given":"Xiaochun","family":"Dai","sequence":"first","affiliation":[{"name":"Wuhan Fourth Hospital"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chun","family":"Xia","sequence":"additional","affiliation":[{"name":"Wuhan Wuchang Hospital"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fang","family":"Zhang","sequence":"additional","affiliation":[{"name":"Wuhan Fourth Hospital"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xinci","family":"Huang","sequence":"additional","affiliation":[{"name":"Wuhan Fourth Hospital"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun","family":"Ye","sequence":"additional","affiliation":[{"name":"Wuhan Fourth Hospital"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dapeng","family":"Wan","sequence":"additional","affiliation":[{"name":"Wuhan Fourth Hospital"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6234-8112","authenticated-orcid":false,"given":"Ji","family":"Zeng","sequence":"additional","affiliation":[{"name":"Wuhan Fourth Hospital"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,9,30]]},"reference":[{"key":"e_1_3_5_2_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41574-019-0312-5"},{"key":"e_1_3_5_3_2","doi-asserted-by":"publisher","DOI":"10.3390\/ijms24054642"},{"key":"e_1_3_5_4_2","doi-asserted-by":"publisher","DOI":"10.1152\/physrev.00014.2015"},{"key":"e_1_3_5_5_2","doi-asserted-by":"publisher","DOI":"10.1530\/EJE-14-0158"},{"key":"e_1_3_5_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jsbmb.2013.11.003"},{"key":"e_1_3_5_7_2","doi-asserted-by":"publisher","DOI":"10.3390\/nu16030391"},{"key":"e_1_3_5_8_2","doi-asserted-by":"publisher","DOI":"10.1093\/ajcn\/87.4.1087S"},{"key":"e_1_3_5_9_2","doi-asserted-by":"publisher","DOI":"10.1017\/S0954422409990151"},{"key":"e_1_3_5_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jsbmb.2023.106328"},{"key":"e_1_3_5_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cca.2012.09.002"},{"key":"e_1_3_5_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinbiochem.2015.05.021"},{"key":"e_1_3_5_13_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00216-015-8733-z"},{"key":"e_1_3_5_14_2","unstructured":"Centers for Disease Control and Prevention (CDC). Vitamin D standardization-certification program (VDSCP). Accessed July 22 2022. https:\/\/www.cdc.gov\/clinical-standardization-programs\/php\/vitamin-d\/improving-performance-vdscp.html. https:\/\/www.cdc.gov\/clinical-standardization-programs\/php\/vitamin-d\/list-of-vitamin-d-certified-assays.html"},{"key":"e_1_3_5_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jsbmb.2017.07.018"},{"key":"e_1_3_5_16_2","volume-title":"Evaluation of detection capability for clinical laboratory measurement procedures; approved guideline","author":"Clinical and Laboratory Standards Institute","year":"2012","unstructured":"Clinical and Laboratory Standards Institute. Evaluation of detection capability for clinical laboratory measurement procedures; approved guideline. 2nd ed. Berwyn, 2012. CLSI Document EP17-A2.","edition":"2"},{"key":"e_1_3_5_17_2","volume-title":"Evaluation of precision of quantitative measurement procedures; approved guideline","author":"CLSI. 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