{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,5]],"date-time":"2025-11-05T04:26:34Z","timestamp":1762316794888,"version":"build-2065373602"},"reference-count":30,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2025,9,9]],"date-time":"2025-09-09T00:00:00Z","timestamp":1757376000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,11,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>While clinical laboratories routinely perform automated chemistry assays on approved specimens (e.g., plasma and serum), the FDA has not evaluated the validity of these assays for nonapproved specimens (e.g., various body fluids). To meet College of American Pathologists\u2019 regulatory requirements, clinical laboratories must evaluate body fluid matrix effects. However, full validation studies are challenging due to time and labor demands. Therefore, a rapid and practical approach for validating body fluids benefits clinical laboratories by improving efficiency and minimizing resources utilized.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Excess body fluids and plasma specimens were collected and frozen until testing was performed. Pooled body fluid specimens were spiked with a 10% spike solution (pooled plasma) containing analyte mixtures with measured concentrations. Matrix interference studies and dilution studies were performed on the Roche cobas automated (6000\/8000) analyzers.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The matrix effects for albumin, amylase, blood urea nitrogen, cholesterol, creatinine, glucose, lactate, lactate dehydrogenase, lipase, potassium, sodium, total bilirubin, total protein, triglycerides, and uric acid were all within acceptable limits (\u00b120% of full recovery). However, lipase was observed to be unstable in peritoneal fluid. Dilution linearity was confirmed for all analytes in pleural, peritoneal, ascites, and synovial fluids (R2 &amp;gt; 0.90).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Our study describes a rapid and practical approach for evaluating body fluid matrix effects in automated clinical chemistry assays. By streamlining the validation process, this approach can help laboratories maintain compliance while minimizing time and resources.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jalm\/jfaf109","type":"journal-article","created":{"date-parts":[[2025,7,21]],"date-time":"2025-07-21T11:17:15Z","timestamp":1753096635000},"page":"1552-1563","source":"Crossref","is-referenced-by-count":0,"title":["A Rapid Approach for Assessing Body Fluid Matrix Effects"],"prefix":"10.1093","volume":"10","author":[{"given":"Mengyuan","family":"Ge","sequence":"first","affiliation":[{"name":"Department of Pathology, UC San Diego Health , San Diego, CA ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Spencer","family":"Seely","sequence":"additional","affiliation":[{"name":"Department of Pathology, UC San Diego Health , San Diego, CA ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael J","family":"Kelner","sequence":"additional","affiliation":[{"name":"Department of Pathology, UC San Diego Health , San Diego, CA ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert L","family":"Fitzgerald","sequence":"additional","affiliation":[{"name":"Department of Pathology, UC San Diego Health , San Diego, CA ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Raymond T","family":"Suhandynata","sequence":"additional","affiliation":[{"name":"Department of Pathology, UC San Diego Health , San Diego, CA ,","place":["United States"]},{"name":"Skaggs School of Pharmacy and Pharmaceutical Sciences, UC San Diego Health , La Jolla, CA ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2025,9,9]]},"reference":[{"author":"FDA","key":"2025110423215323700_jfaf109-B1"},{"author":"Federal Register","key":"2025110423215323700_jfaf109-B2"},{"key":"2025110423215323700_jfaf109-B3","doi-asserted-by":"crossref","first-page":"315","DOI":"10.1093\/labmed\/lmaa086","article-title":"A high-level overview of the regulations surrounding a clinical laboratory and upcoming regulatory challenges for laboratory developed tests","volume":"52","author":"Graden","year":"2021","journal-title":"Lab Med"},{"key":"2025110423215323700_jfaf109-B4","doi-asserted-by":"crossref","first-page":"122","DOI":"10.1093\/ajcp\/aqz096","article-title":"Regulation of laboratory-developed tests","volume":"152","author":"Genzen","year":"2019","journal-title":"Am J Clin Pathol"},{"key":"2025110423215323700_jfaf109-B5","doi-asserted-by":"crossref","first-page":"44","DOI":"10.1016\/j.clinbiochem.2018.05.002","article-title":"An approach to analytical validation and testing of body fluid assays for the automated clinical laboratory","volume":"58","author":"Block","year":"2018","journal-title":"Clin Biochem"},{"key":"2025110423215323700_jfaf109-B6","doi-asserted-by":"crossref","first-page":"911","DOI":"10.1016\/j.clinbiochem.2015.05.012","article-title":"Body fluid matrix evaluation on a Roche cobas 8000 system","volume":"48","author":"Owen","year":"2015","journal-title":"Clin Biochem"},{"author":"College of American Pathologists","key":"2025110423215323700_jfaf109-B7"},{"key":"2025110423215323700_jfaf109-B8","volume-title":"Quick guide to body fluid testing","author":"Block","year":"2023","edition":"2nd Ed"},{"key":"2025110423215323700_jfaf109-B9","doi-asserted-by":"crossref","first-page":"469","DOI":"10.1016\/B978-0-12-815499-1.00027-2","volume-title":"Contemporary practice in clinical chemistry","author":"Block","year":"2020"},{"year":"2024","key":"2025110423215323700_jfaf109-B10"},{"year":"2024","key":"2025110423215323700_jfaf109-B11"},{"year":"2024","key":"2025110423215323700_jfaf109-B12"},{"year":"2023","key":"2025110423215323700_jfaf109-B13"},{"year":"2024","key":"2025110423215323700_jfaf109-B14"},{"year":"2024","key":"2025110423215323700_jfaf109-B15"},{"year":"2024","key":"2025110423215323700_jfaf109-B16"},{"year":"2023","key":"2025110423215323700_jfaf109-B17"},{"year":"2024","key":"2025110423215323700_jfaf109-B18"},{"year":"2025","key":"2025110423215323700_jfaf109-B19"},{"year":"2025","key":"2025110423215323700_jfaf109-B20"},{"year":"2024","key":"2025110423215323700_jfaf109-B21"},{"year":"2023","key":"2025110423215323700_jfaf109-B22"},{"year":"2024","key":"2025110423215323700_jfaf109-B23"},{"year":"2023","key":"2025110423215323700_jfaf109-B24"},{"key":"2025110423215323700_jfaf109-B25","doi-asserted-by":"crossref","first-page":"230","DOI":"10.5951\/MT.93.3.0230","article-title":"The coefficient of determination: understanding r squared and R squared","volume":"93","author":"Barrett","year":"2000","journal-title":"Math Teach"},{"key":"2025110423215323700_jfaf109-B26","volume-title":"Statistical inference","author":"Casella","year":"2002","edition":"2nd Ed"},{"key":"2025110423215323700_jfaf109-B27","doi-asserted-by":"crossref","first-page":"24","DOI":"10.1016\/j.plabm.2016.03.003","article-title":"Filling in the gaps with non-standard body fluids","volume":"5","author":"Lo","year":"2016","journal-title":"Pract Lab Med"},{"key":"2025110423215323700_jfaf109-B28","doi-asserted-by":"crossref","first-page":"1126","DOI":"10.1016\/j.clinbiochem.2015.06.011","article-title":"Fecal electrolyte testing for evaluation of unexplained diarrhea: validation of body fluid test accuracy in the absence of a reference method","volume":"48","author":"Voskoboev","year":"2015","journal-title":"Clin Biochem"},{"key":"2025110423215323700_jfaf109-B29","doi-asserted-by":"crossref","first-page":"271","DOI":"10.1016\/B978-0-12-822949-1.00012-7","volume-title":"Tutorials in clinical chemistry","author":"Hashim","year":"2024"},{"key":"2025110423215323700_jfaf109-B30","doi-asserted-by":"crossref","first-page":"121","DOI":"10.1016\/j.cca.2013.08.011","article-title":"Performance specifications of common chemistry analytes on the AU series of chemistry analyzers for miscellaneous body fluids","volume":"426","author":"Lin","year":"2013","journal-title":"Clin Chim Acta"}],"container-title":["The Journal of Applied Laboratory Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/jalm\/article-pdf\/10\/6\/1552\/64224955\/jfaf109.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jalm\/article-pdf\/10\/6\/1552\/64224955\/jfaf109.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,5]],"date-time":"2025-11-05T04:21:58Z","timestamp":1762316518000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jalm\/article\/10\/6\/1552\/8249557"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9,9]]},"references-count":30,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2025,9,9]]},"published-print":{"date-parts":[[2025,11,4]]}},"URL":"https:\/\/doi.org\/10.1093\/jalm\/jfaf109","relation":{},"ISSN":["2475-7241"],"issn-type":[{"type":"electronic","value":"2475-7241"}],"subject":[],"published-other":{"date-parts":[[2025,11]]},"published":{"date-parts":[[2025,9,9]]}}}