{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T03:40:03Z","timestamp":1792381203670,"version":"4.4.0"},"reference-count":34,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2026,5,25]],"date-time":"2026-05-25T00:00:00Z","timestamp":1779667200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,5,25]],"date-time":"2026-05-25T00:00:00Z","timestamp":1779667200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Int J Lab Hematology"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Acquired hypofibrinogenemia is frequently associated with major bleeding and requires prompt correction. Rapid and accurate quantification of fibrinogen is essential to guide hemostatic therapy and improve patient outcomes. The qLabs FIB system provides fibrinogen results within minutes at the bedside, supporting timely diagnostic assessment and therapeutic decision\u2010making. This study aimed to validate the device analytical performance in a prospective, observational, multicenter setting by comparing whole\u2010blood qLabs FIB results with lab\u2010based plasma fibrinogen.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Fibrinogen concentrations from 463 citrated whole\u2010blood samples were measured in parallel using the qLabs FIB and the Clauss method across 8 clinical sites.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Overall, a strong correlation was observed between the qLabs FIB and the Clauss laboratory method (\n                      <jats:italic>r<\/jats:italic>\n                      \u2009=\u20090.94). The median of relative differences did not differ significantly between clinical sites. Receiver operating characteristic analysis showed sensitivities and specificities in the 90% range for identifying fibrinogen concentrations below the clinical decision thresholds of 1.5 and 2.0\u2009g\/L.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This study demonstrated a strong agreement of the qLabs FIB to the standard Clauss assay while providing rapid, near\u2010patient fibrinogen measurements. This multicenter study confirms the initial performance of the system from a larger number of samples. The integration of qLabs FIB testing into routine clinical practice could support earlier, more targeted hemostatic interventions, thereby improving the safety and effectiveness of bleeding management.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/ijlh.70133","type":"journal-article","created":{"date-parts":[[2026,5,26]],"date-time":"2026-05-26T00:29:33Z","timestamp":1779755373000},"page":"1173-1180","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Rapid Fibrinogen Assessment With the\n                    <scp>qLabs FIB<\/scp>\n                    Point\u2010of\u2010Care System: Results From a Multicenter Clinical Validation Study"],"prefix":"10.1111","volume":"48","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-6022-7677","authenticated-orcid":false,"given":"Sandra","family":"Sanfilippo","sequence":"first","affiliation":[{"name":"Diagnostica Stago R&amp;D POC Solutions Department  Gennevilliers France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leslie","family":"Buisson","sequence":"additional","affiliation":[{"name":"Diagnostica Stago R&amp;D POC Solutions Department  Gennevilliers France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Blanche","family":"Delabie","sequence":"additional","affiliation":[{"name":"Diagnostica Stago R&amp;D POC Solutions Department  Gennevilliers France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sophie","family":"Le Bellego","sequence":"additional","affiliation":[{"name":"Diagnostica Stago R&amp;D POC Solutions Department  Gennevilliers France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie\u2010Eglantine","family":"Dujaric","sequence":"additional","affiliation":[{"name":"Diagnostica Stago R&amp;D Design and Biological Applications Department  Gennevilliers France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thibault","family":"Donnet","sequence":"additional","affiliation":[{"name":"Diagnostica Stago R&amp;D POC Solutions Department  Gennevilliers France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,5,25]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1080\/10408347.2020.1793098"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13054\u2010016\u20101265\u2010x"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/1471\u20100528.14178"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/ALN.0000000000000463"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/EJA.0000000000000630"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1097\/00000539\u2010199508000\u201000026"},{"key":"e_1_2_9_8_1","doi-asserted-by":"crossref","unstructured":"P.Whiting M.Al M.Westwood et\u00a0al. \u201cViscoelastic Point\u2010of\u2010Care Testing to Assist With the Diagnosis Management and Monitoring of Haemostasis: A Systematic Review and Cost\u2010Effectiveness Analysis \u201d Southampton (UK): NIHR Journals Library (Health Technology Assessment No. 19.58.) 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