{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T17:59:47Z","timestamp":1791223187398,"version":"4.1.0"},"reference-count":20,"publisher":"Public Library of Science (PLoS)","issue":"10","license":[{"start":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T00:00:00Z","timestamp":1791158400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Labex Inc."}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:p>Errors in the preanalytical phase are influenced by several factors, including blood collection tubes. Labex, Inc. has developed UNI-VAC tubes using a separation gel formulated with fatty acid acrylamide to enhance stability. We aimed to compare the performance of the UNI-VAC tubes with Becton, Dickinson and Company Vacutainer tubes for 53 analytes. Forty adult outpatients were prospectively enrolled in the comparison study, and an additional 20 participants were included to evaluate lot-to-lot variability. Four UNI-VAC tube types (serum separator, ethylenediaminetetraacetic acid [EDTA], sodium citrate, and sodium fluoride) were compared with their Vacutainer counterparts. Comparative performance was evaluated using Passing\u2013Bablok regression and bias criteria from the European Federation of Clinical Chemistry and Laboratory Medicine Biological Variation Database and Westgard specifications. Stability was assessed for EDTA tubes at 24 h and sodium fluoride tubes at 24\u201372 h (4\u00b0C storage). The lot-to-lot variability of the EDTA tubes was examined across the three UNI-VAC and two Vacutainer lots. Fifty (94%) analytes met the predefined acceptability criteria. Lactate dehydrogenase (\u22124.3%), mean corpuscular volume (1.5%), and mean corpuscular hemoglobin concentration (\u22121.0%) marginally exceeded these limits, although the differences were small and unlikely to be clinically significant. No visible gel instability or other visible tube-related issues were observed. EDTA tubes demonstrated stability after 24 h, although the basophil percentages and platelet indices showed reduced consistency. Glucose values were stable for up to 48 h but declined at 72 h in both tubes. The lot-to-lot variability of the UNI-VAC EDTA tubes was comparable to that of the Vacutainer tubes. UNI-VAC tubes show a clinical performance equivalent to that of Vacutainer tubes for most analytes, with acceptable stability. These findings indicate that UNI-VAC tubes represent a reliable alternative for clinical laboratory use, with further validation in larger patient cohorts.<\/jats:p>","DOI":"10.1371\/journal.pone.0349489","type":"journal-article","created":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T17:39:41Z","timestamp":1791221981000},"page":"e0349489","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["Evaluation of UNI-VAC serum separator, ethylenediaminetetraacetic acid, sodium citrate, and sodium fluoride tubes: A comparison with Becton, Dickinson and Company Vacutainer tubes"],"prefix":"10.1371","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3950-4946","authenticated-orcid":true,"given":"Kuenyoul","family":"Park","sequence":"first","affiliation":[{"name":"Hanyang University Seoul Hospital, Hanyang University College of Medicine","place":["Seoul, Republic of Korea"],"department":["Department of Laboratory Medicine"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5344-763X","authenticated-orcid":true,"given":"Joonsang","family":"Yu","sequence":"additional","affiliation":[{"name":"Sanggye Paik Hospital, Inje University College of Medicine","place":["Seoul, Republic of Korea"],"department":["Department of Laboratory Medicine"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wonho","family":"Choe","sequence":"additional","affiliation":[{"name":"Uijeongbu Eulji Medical Center, Eulji University","place":["Uijeongbu, Republic of Korea"],"department":["Department of Laboratory Medicine"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1715-3487","authenticated-orcid":true,"given":"Soo Jin","family":"Yoo","sequence":"additional","affiliation":[{"name":"Uijeongbu Eulji Medical Center, Eulji University","place":["Uijeongbu, Republic of Korea"],"department":["Department of Laboratory Medicine"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2026,10,5]]},"reference":[{"issue":"4","key":"pone.0349489.ref001","doi-asserted-by":"crossref","first-page":"358","DOI":"10.1515\/CCLM.2006.073","article-title":"Preanalytical variability: The dark side of the moon in laboratory testing","volume":"44","author":"G Lippi","year":"2006","journal-title":"Clin Chem Lab Med"},{"issue":"3","key":"pone.0349489.ref002","first-page":"429","article-title":"The preanalytic phase. An important component of laboratory medicine","volume":"113","author":"S Narayanan","year":"2000","journal-title":"Am J Clin Pathol"},{"issue":"5","key":"pone.0349489.ref003","doi-asserted-by":"crossref","first-page":"491","DOI":"10.1111\/j.1751-553X.2009.01211.x","article-title":"Under-filled blood collection tubes containing K2EDTA as anticoagulant are acceptable for automated complete blood counts, white blood cell differential, and reticulocyte count","volume":"32","author":"M Xu","year":"2010","journal-title":"Int J Lab Hematol"},{"key":"pone.0349489.ref004","doi-asserted-by":"crossref","first-page":"69","DOI":"10.1016\/j.cca.2021.01.016","article-title":"Preanalytical error: Improper gel barrier formation in a serum separator tube despite appropriate centrifugation condition","volume":"516","author":"L Allard","year":"2021","journal-title":"Clin Chim Acta"},{"issue":"1","key":"pone.0349489.ref005","doi-asserted-by":"crossref","first-page":"31","DOI":"10.11613\/BM.2014.006","article-title":"Interferences from blood collection tube components on clinical chemistry assays","volume":"24","author":"RAR Bowen","year":"2014","journal-title":"Biochem Med (Zagreb)"},{"key":"pone.0349489.ref006","doi-asserted-by":"crossref","first-page":"1454","DOI":"10.1016\/j.cca.2012.06.001","article-title":"Effect of blood collection tubes on the incidence of artifactual hyperkalemia on patient samples from an outreach clinic","volume":"413","author":"N Babic","year":"2012","journal-title":"Clin Chim Acta"},{"key":"pone.0349489.ref007","unstructured":"Kim GS, Oh SJ. Inventors; Labex Co., Ltd., assignee. Composition for serum or plasma separation. Republic of Korea patent KR 10-2743413. 2024."},{"key":"pone.0349489.ref008","volume-title":"Measurement procedure comparison and bias estimation using patient samples. CLSI Guideline EP09c","author":"CLSI","year":"2018","edition":"3"},{"key":"pone.0349489.ref009","volume-title":"Validation and verification of tubes for venous and capillary blood specimen collection; approved guideline. CLSI Document GP34-A","author":"CLSI","year":"2010"},{"issue":"3","key":"pone.0349489.ref010","doi-asserted-by":"crossref","first-page":"311","DOI":"10.1515\/CCLM.2006.054","article-title":"Influence of hemolysis on routine clinical chemistry testing","volume":"44","author":"G Lippi","year":"2006","journal-title":"Clin Chem Lab Med"},{"issue":"12","key":"pone.0349489.ref011","doi-asserted-by":"crossref","first-page":"2242","DOI":"10.1093\/clinchem\/48.12.2242","article-title":"Stability studies of twenty-four analytes in human plasma and serum","volume":"48","author":"BLJ Boyanton","year":"2002","journal-title":"Clin Chem"},{"issue":"5","key":"pone.0349489.ref012","doi-asserted-by":"crossref","first-page":"602","DOI":"10.1002\/jcla.21909","article-title":"Stability of routine biochemical analytes in whole blood and plasma from lithium heparin gel tubes during 6-hr storage","volume":"30","author":"D Monneret","year":"2016","journal-title":"J Clin Lab Anal"},{"issue":"1","key":"pone.0349489.ref013","doi-asserted-by":"crossref","first-page":"114","DOI":"10.3343\/alm.2021.41.1.114","article-title":"Comparison of three blood collection tubes for 35 biochemical analytes: The Becton dickinson barricor tube, serum separating tube, and plasma separating tube","volume":"41","author":"S Shin","year":"2021","journal-title":"Ann Lab Med"},{"issue":"2","key":"pone.0349489.ref014","doi-asserted-by":"crossref","first-page":"230","DOI":"10.1177\/0004563216651647","article-title":"The economic impact of poor sample quality in clinical chemistry laboratories: Results from a global survey","volume":"54","author":"EP Erdal","year":"2017","journal-title":"Ann Clin Biochem"},{"key":"pone.0349489.ref015","doi-asserted-by":"crossref","first-page":"16","DOI":"10.1016\/j.plabm.2015.12.001","article-title":"The stability of quantitative blood count parameters using the ADVIA 2120i hematology analyzer","volume":"4","author":"E Pint\u00e9r","year":"2015","journal-title":"Pract Lab Med"},{"issue":"2","key":"pone.0349489.ref016","doi-asserted-by":"crossref","first-page":"92","DOI":"10.3343\/lmo.2015.5.2.92","article-title":"A comparison of the performance of soyagreentec ampulab EDTA and sodium citrate tubes with that of BD vacutainer tubes","volume":"5","author":"JH Lee","year":"2015","journal-title":"Lab Med Online"},{"issue":"6","key":"pone.0349489.ref017","doi-asserted-by":"crossref","first-page":"470","DOI":"10.1080\/00365513.2020.1783570","article-title":"Stability of complete blood count parameters depends on the storage temperature, storage time, transport position and selected stability criterion","volume":"80","author":"H Kayadibi","year":"2020","journal-title":"Scand J Clin Lab Invest"},{"issue":"3","key":"pone.0349489.ref018","doi-asserted-by":"crossref","first-page":"252","DOI":"10.5937\/jomb0-27945","article-title":"Stability of hematological analytes during 48 hours storage at three temperatures using Cell-Dyn hematology analyzer","volume":"40","author":"OS Unalli","year":"2021","journal-title":"J Med Biochem"},{"issue":"2","key":"pone.0349489.ref019","doi-asserted-by":"crossref","DOI":"10.1002\/jcla.23060","article-title":"A comparison of stability of chemical analytes in plasma from the BD Vacutainer\u00ae Barricor\u2122 tube with mechanical separator versus tubes containing gel separator","volume":"34","author":"G Gawria","year":"2020","journal-title":"J Clin Lab Anal"},{"issue":"10","key":"pone.0349489.ref020","doi-asserted-by":"crossref","first-page":"1943","DOI":"10.1515\/cclm-2012-0735","article-title":"Citric\/citrate buffer: an effective antiglycolytic agent","volume":"51","author":"IG del Pino","year":"2013","journal-title":"Clin Chem Lab Med"}],"container-title":["PLOS One"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0349489","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T17:39:46Z","timestamp":1791221986000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0349489"}},"subtitle":[],"editor":[{"given":"Hafiz Muhammad Umer","family":"Farooqi","sequence":"first","affiliation":[{"name":"Children\u2019s Hospital of Orange County","place":["UNITED STATES OF AMERICA"]}],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2026,10,5]]},"references-count":20,"journal-issue":{"issue":"10","published-online":{"date-parts":[[2026,10,5]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0349489","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,5]]}}}