{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T15:28:40Z","timestamp":1787153320488,"version":"build-2736575974"},"reference-count":22,"publisher":"Oxford University Press (OUP)","license":[{"start":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T00:00:00Z","timestamp":1787097600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Lipoprotein(a) [Lp(a)] is an independent, genetically determined cardiovascular risk factor. Although consensus recommends reporting Lp(a) in molar units using assays with minimized apolipoprotein(a) [apo(a)] isoform size\u2013related bias, some laboratories still use mass units with conversion formulas of uncertain reliability. This study describes the first adaptation and validation of the Roche Tina-quant\u00ae Lp(a) Gen.2 assay [TQ-Lp(a)] on the Atellica Solution platform, including method comparison and evaluation of formula-based mass-to-molar conversion.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A total of 126 serum samples were analyzed using 3 approaches: Roche TQ-Lp(a) as the molar comparator method, adapted Atellica-TQ-Lp(a), and native Siemens Lp(a) on Atellica CH, which reports results in mg\/dL. Siemens mass-based results were converted to nmol\/L using the manufacturer\u2019s equation. Analytical performance was assessed according to Spanish Society of Laboratory Medicine recommendations. Method comparison included Passing\u2013Bablok regression, Bland\u2013Altman, and Cohen \u03ba at clinically relevant thresholds.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Atellica-TQ-Lp(a) demonstrated acceptable precision (CV &amp;lt;6%), excellent linearity (r = 0.99), and adequate sensitivity (limit of quantification, 8\u2005nmol\/L). No relevant interference was observed, and stability was maintained for 4 days under refrigerated and frozen conditions. Agreement with the comparator method was high (slope, 0.99; intercept, 3.9\u2005nmol\/L; r = 0.99), with minimal constant bias and high categorical concordance (weighted \u03ba = 0.98). In contrast, formula-derived values showed proportional bias (slope, 1.27), moderate agreement (weighted \u03ba = 0.78), and frequent upward reclassification at \u2265125\u2005nmol\/L.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The Roche Tina-quant\u00ae Lp(a) Gen.2 assay can be implemented on Atellica CH to report Lp(a) in nmol\/L with high analytical comparability to the Roche\/cobas implementation. Fixed mg\/dL-to-nmol\/L conversion formulas introduce systematic bias and clinically relevant misclassification.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jalm\/jfag122","type":"journal-article","created":{"date-parts":[[2026,7,25]],"date-time":"2026-07-25T11:37:38Z","timestamp":1784979458000},"source":"Crossref","is-referenced-by-count":0,"title":["Implementation of an Automated Lipoprotein(a) Assay on a Third-Party Automated Analyzer: Validation, Method Comparison, and Clinical Impact of Formula-Based Mass-to-Molar Conversion"],"prefix":"10.1093","author":[{"ORCID":"https:\/\/orcid.org\/0009-0008-6692-3808","authenticated-orcid":false,"given":"Nerea","family":"Sainz-Pastor","sequence":"first","affiliation":[{"name":"Laboratorio CORE, Servicio de Bioqu\u00edmica y Gen\u00e9tica Molecular, CDB, Hospital Cl\u00ednic de Barcelona , Barcelona ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvia","family":"Camos Anguila","sequence":"additional","affiliation":[{"name":"Servicio de An\u00e1lisis Cl\u00ednicos, Laboratorio Cl\u00ednic Territorial ICS-IAS Girona, Hospital Universitari Doctor Josep Trueta , Girona ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-9961-1446","authenticated-orcid":false,"given":"Miriam","family":"Alb\u00e9niz Abaigar","sequence":"additional","affiliation":[{"name":"Laboratorio CORE, Servicio de Bioqu\u00edmica y Gen\u00e9tica Molecular, CDB, Hospital Cl\u00ednic de Barcelona , Barcelona ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana","family":"Molina","sequence":"additional","affiliation":[{"name":"Laboratorio CORE, Servicio de Bioqu\u00edmica y Gen\u00e9tica Molecular, CDB, Hospital Cl\u00ednic de Barcelona , Barcelona ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helena","family":"Castell\u00e0","sequence":"additional","affiliation":[{"name":"Laboratorio CORE, Servicio de Bioqu\u00edmica y Gen\u00e9tica Molecular, CDB, Hospital Cl\u00ednic de Barcelona , Barcelona ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc","family":"Delgado","sequence":"additional","affiliation":[{"name":"Laboratorio CORE, Servicio de Bioqu\u00edmica y Gen\u00e9tica Molecular, CDB, Hospital Cl\u00ednic de Barcelona , Barcelona ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9 Luis","family":"Bedini","sequence":"additional","affiliation":[{"name":"Laboratorio CORE, Servicio de Bioqu\u00edmica y Gen\u00e9tica Molecular, CDB, Hospital Cl\u00ednic de Barcelona , Barcelona ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebeca","family":"Mu\u00f1oz","sequence":"additional","affiliation":[{"name":"Laboratorio CORE, Servicio de Bioqu\u00edmica y Gen\u00e9tica Molecular, CDB, Hospital Cl\u00ednic de Barcelona , Barcelona ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emilio","family":"Ortega","sequence":"additional","affiliation":[{"name":"Servicio de Endocrinolog\u00eda y Nutrici\u00f3n, Hospital Cl\u00ednic Barcelona , Barcelona ,","place":["Spain"]},{"name":"CIBER of Physiopathology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III (ISCIII) ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naira","family":"Rico","sequence":"additional","affiliation":[{"name":"Laboratorio CORE, Servicio de Bioqu\u00edmica y Gen\u00e9tica Molecular, CDB, Hospital Cl\u00ednic de Barcelona , Barcelona 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