{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T09:56:16Z","timestamp":1753869376068,"version":"3.41.2"},"reference-count":21,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2025,3,25]],"date-time":"2025-03-25T00:00:00Z","timestamp":1742860800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Laboratory Analysis"],"published-print":{"date-parts":[[2025,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Point\u2010of\u2010care testing of blood gases plays a critical role in patient management. The aim of this study was to verify the manufacturer's specifications of the Nova Stat Profile Prime Plus Analyser, along with a comparison study with the GEM Premier 4000 Blood Gas Analyser.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Parameters analysed were pH, pCO<jats:sub>2<\/jats:sub>, pO<jats:sub>2<\/jats:sub>, Na<jats:sup>+<\/jats:sup>, Cl<jats:sup>\u2212<\/jats:sup>, K<jats:sup>+<\/jats:sup>, iCa, lactate, and glucose. Data for the precision and bias study were generated using control samples in a 5\u2009\u00d7\u20095 study design. Linearity was checked using a five\u2010level Linearity Control Set, while comparison was done between the Nova and GEM analysers using whole blood samples (<jats:italic>N<\/jats:italic>\u2009=\u2009103). Acceptance was based on the CLIA TE<jats:sub>a<\/jats:sub> for all analytes except for lactate, for which the TE<jats:sub>a<\/jats:sub> defined by CAP and AAB was used.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The within\u2010run and between\u2010run CV<jats:sub>R<\/jats:sub>% precision were all lower than the claimed CVs%, except for pCO<jats:sub>2<\/jats:sub> control level 2 within run (CV% 1.5 [claim CV% 1.1]) and iCa control level 5 between run (CV% 1.42 [claim 1.12]). The observed bias for all parameters was within the calculated lower and upper bias limits. Linearity was verified for all analytes except for Na<jats:sup>+<\/jats:sup>. Upon\u00a0comparison of the Nova and GEM analysers, a correlation coefficient above 0.95 was observed for most parameters.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The Nova Stat Profile Prime Plus analyser meets the manufacturer's precision and bias claims. Linearity was confirmed for most analytes. There was a good correlation between the Nova and GEM Blood Gas analyser at concentrations within the reference range intervals for all investigated parameters.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcla.70006","type":"journal-article","created":{"date-parts":[[2025,3,27]],"date-time":"2025-03-27T10:42:11Z","timestamp":1743072131000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["The Verification Process of a <scp>POC<\/scp> Blood Gas Analyser\u2014The Nova Stat Profile Primer Plus Analyser"],"prefix":"10.1002","volume":"39","author":[{"given":"Joseph","family":"Costa","sequence":"first","affiliation":[{"name":"GGH Medical Laboratory Services Gozo General Hospital  Victoria Gozo Malta"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-1995-179X","authenticated-orcid":false,"given":"Ritienne","family":"Attard","sequence":"additional","affiliation":[{"name":"GGH Medical Laboratory Services Gozo General Hospital  Victoria Gozo Malta"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"the GGH Medical Laboratory Services team","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,3,25]]},"reference":[{"issue":"23","key":"e_1_2_11_2_1","first-page":"11653","article-title":"The Importance of Arterial Blood Gas Analysis as a Systemic Diagnosis Approach in Assessing and Preventing Chronic Diseases, From Emergency Medicine to the Daily Practice","volume":"27","author":"Balzanelli M. G.","year":"2023","journal-title":"European Review for Medical and Pharmacological Sciences"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00134-017-4824-y"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12245-023-00486-0"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.29390\/cjrt\u20102021\u2010008"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcla.22885"},{"key":"e_1_2_11_7_1","unstructured":"Nova Biomedical Stat Profile Prime Plus\u00ae Analyser Instructions for Use Manual 2018\u20102020Nova Biomedical Corporation Waltham."},{"key":"e_1_2_11_8_1","unstructured":"FDA Clears Stat Profile Prime Plus Analyzer for Point\u2010of\u2010Care Use2020 https:\/\/clpmag.com\/diagnostic\u2010technologies\/clinical\u2010chemistry\/blood\u2010gas\/fda\u2010clears\u2010stat\u2010profile\u2010prime\u2010plus\u2010analyzer\u2010for\u2010point\u2010of\u2010care\u2010use\/#:~:text=FDA%20has%20cleared%20the%20Stat as%20little%20as%201%20minute."},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.5937\/jomb0-24764"},{"volume-title":"User Verification of Precision and Estimation of Bias; Approved Guideline","year":"2014","author":"CLSI","key":"e_1_2_11_10_1"},{"volume-title":"Measurement Procedure Comparison and Bias Estimation Using Patient Samples","year":"2018","author":"CLSI","key":"e_1_2_11_11_1"},{"volume-title":"Evaluation of Linearity of Quantitative Measurement Procedures","year":"2020","key":"e_1_2_11_12_1"},{"key":"e_1_2_11_13_1","unstructured":"S.Westgard. Home. 2023 Analytical Evaluation of a POC Blood Analysis System https:\/\/westgard.com\/qc\u2010applications\/sigma\u2010metric\u2010analysis\/632\u2010poc\u2010system\u2010analysis.html."},{"key":"e_1_2_11_14_1","unstructured":"\u201cStat Profile Prime Plus Analytical Performance Testing.\u201dTest Sites: Boston Tampa USA Nova Biomedical 469A v6.0 04.26.2018."},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1373\/jalm.2019.029900"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.11648\/j.plm.20200402.11"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0736-4679(02)00429-8"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.11613\/BM.2013.005"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/bs.acc.2019.01.006"},{"issue":"8","key":"e_1_2_11_20_1","article-title":"A Comparative Assessment of the Nova STAT Profile Prime Plus\u00ae Critical Care Analyzer","volume":"12","author":"Jawa A.","year":"2020","journal-title":"Cureus"},{"key":"e_1_2_11_21_1","first-page":"S104","article-title":"Sodium determination in biological fluids","volume":"3","author":"Cristol J. P.","year":"2007","journal-title":"N\u00e9phrologie & Th\u00e9rapeutique"},{"issue":"2","key":"e_1_2_11_22_1","first-page":"158","article-title":"Point of Care Testing of Serum Electrolytes and Lactate in Sick Children","volume":"32","author":"Dabas A.","year":"2021","journal-title":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine"}],"container-title":["Journal of Clinical Laboratory Analysis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcla.70006","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,28]],"date-time":"2025-04-28T04:08:49Z","timestamp":1745813329000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/jcla.70006"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,3,25]]},"references-count":21,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2025,4]]}},"alternative-id":["10.1002\/jcla.70006"],"URL":"https:\/\/doi.org\/10.1002\/jcla.70006","archive":["Portico"],"relation":{},"ISSN":["0887-8013","1098-2825"],"issn-type":[{"type":"print","value":"0887-8013"},{"type":"electronic","value":"1098-2825"}],"subject":[],"published":{"date-parts":[[2025,3,25]]},"assertion":[{"value":"2024-10-28","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-02-07","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-03-25","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70006"}}