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The Accre 8 Point-of-Care (POC) Chemiluminescent Immunoassay (CLIA) system offers a compact design, rapid single-step operation, and minimal calibration requirements. This study evaluates Accre 8\u2019s performance against established CLIA immunoassays (Abbott and Roche) and LC-MS\/MS, the gold standard for Vit B12 quantification. A total of 297 serum samples, spanning deficient to sufficient Vit B12 levels, were analyzed. Accre 8 demonstrated a strong correlation with LC-MS\/MS (<jats:italic>r<\/jats:italic>\u2009= 0.94, <jats:italic>p<\/jats:italic>\u2009&lt; 0.001), with median Vit B12 levels closely aligning with LC-MS\/MS (256.0 pmol\/L). Accre 8 exhibited high sensitivity (96.9%) and specificity (86.7%), with Cohen\u2019s Kappa agreement (0.76). Bland-Altman analysis showed a mean bias of -\u200918.5%, while Passing-Bablok regression indicated proportional bias at higher concentrations (slope =\u20091.44). ROC analysis confirmed excellent diagnostic accuracy (AUC =\u20090.98). Accre 8\u2019s strong diagnostic performance, minimal calibration needs, and low sample volume requirements position it as a practical alternative to conventional CLIA systems for Vit B12 assessment, particularly in clinical and resource-limited settings. These findings support its potential integration into routine diagnostic workflows for Vit B12 deficiency screening and monitoring.<\/jats:p>","DOI":"10.1038\/s41598-025-97503-4","type":"journal-article","created":{"date-parts":[[2025,4,17]],"date-time":"2025-04-17T14:45:26Z","timestamp":1744901126000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Accre 8 emerging point of care CLIA system for vitamin B12 assessment compared with three established assays"],"prefix":"10.1038","volume":"15","author":[{"given":"Farah M.","family":"Trad","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tasneem","family":"AlHamad","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nadin","family":"Younes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shaden","family":"Abunasser","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Salma","family":"Younes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Parveen B.","family":"Nizamuddin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dayana El","family":"Chaar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Israa M.","family":"Salameh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nader I.","family":"Al-dewik","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wanida","family":"Laiwattanapaisal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pattramon","family":"Aungbamnet","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pollanat","family":"Loungjinda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Palanee","family":"Ammaranond","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meng","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laith J.","family":"Abu-Raddad","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gheyath K.","family":"Nasrallah","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,4,17]]},"reference":[{"key":"97503_CR1","doi-asserted-by":"publisher","unstructured":"Allen, L. 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