{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,30]],"date-time":"2026-03-30T14:14:21Z","timestamp":1774880061769,"version":"3.50.1"},"reference-count":34,"publisher":"Walter de Gruyter GmbH","issue":"5","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,4,24]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec id=\"j_cclm-2025-1202_abs_001\">\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>The performance of a novel urine particle analyzer, fluidlab 2 (Anvajo GmbH, Dresden, Germany), was evaluated against phase-contrast visual microscopy according to the most recent EFLM European Urinalysis Guideline.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2025-1202_abs_002\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The fluidlab 2 device combines digital holographic microscopy with neural network-based object detection for particle classification. Its compact benchtop design is suitable for bedside use, reducing turnaround times. The analytical performance (imprecision, linearity, LoQ) was evaluated according to the 2023 EFLM Urinalysis Guideline. Method comparison involved the analysis of 450 urine samples, assessing RBC, WBC, and SEC counts against visual microscopy using Passing-Bablok regression and Spearman\u2019s correlation. Bland-Altman plots were used to evaluate the agreement with clinical performance standards, while weighted Cohen\u2019s kappa was used to measure diagnostic agreement on an ordinal\u00a0scale.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2025-1202_abs_003\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      By applying Dahlberg\u2019s procedure, a desirable relative coefficient of variation R(CV)\u00a0\u22642.0 was obtained for RBC and WBC. Linearity of up to 7\u00a0\u00d7\u00a010\n                      <jats:sup>6<\/jats:sup>\n                      \/L and 6\u00a0\u00d7\u00a010\n                      <jats:sup>6<\/jats:sup>\n                      \/L was achieved. The estimated LoQ at CV=30\u202f% reached 20\u00a0\u00d7\u00a010\n                      <jats:sup>6<\/jats:sup>\n                      \/L for RBC and 5\u00a0\u00d7\u00a010\n                      <jats:sup>6<\/jats:sup>\n                      \/L for WBC. Spearman\u2019s correlation coefficient against visual microscopy was 0.86, 0.92 and 0.94 for RBC, WBC and SEC, respectively. Agreement with visual microscopy (Cohen\u2019s weighted kappa) was 0.92 for RBC, 0.93 for WBC, 0.96 for SEC, 0.86 for casts, 0.82 for non-SEC, 0.33 for crystals and 0.51 for bacterial counts.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2025-1202_abs_004\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Fluidlab 2 provides desirable imprecision for RBC and WBC, and meets the criteria for linearity and LoQ. Cohen\u2019s weighted kappa coefficients show an optimal comparison to visual microscopy for RBC, WBC and SEC and a minimum comparison for casts and non-SEC. This evaluation demonstrated promising results for the use of the fluidlab 2 analyzer in a clinical setting to detect kidney-related diseases based on urine particle analysis.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1515\/cclm-2025-1202","type":"journal-article","created":{"date-parts":[[2026,1,2]],"date-time":"2026-01-02T04:55:37Z","timestamp":1767329737000},"page":"1083-1092","source":"Crossref","is-referenced-by-count":0,"title":["Analytical and diagnostic evaluation of the Anvajo fluidlab 2 analyzer: a novel urine particle analyzer for clinical application using digital holographic microscopy?"],"prefix":"10.1515","volume":"64","author":[{"given":"Sigrid","family":"Deprez","sequence":"first","affiliation":[{"name":"Department of Laboratory Medicine , 60200 Ghent University Hospital , Ghent , Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marijn","family":"Speeckaert","sequence":"additional","affiliation":[{"name":"Department of Nephrology , Ghent University Hospital , Ghent , Belgium"},{"name":"Research Foundation-Flanders (FWO) , Brussels , Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5702-6792","authenticated-orcid":false,"given":"Joris","family":"Delanghe","sequence":"additional","affiliation":[{"name":"Department of Diagnostic Sciences , Ghent University , Ghent , Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0240-0679","authenticated-orcid":false,"given":"Matthijs","family":"Oyaert","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , 60200 Ghent University Hospital , Ghent , Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"374","published-online":{"date-parts":[[2026,1,2]]},"reference":[{"key":"2026033013262450520_j_cclm-2025-1202_ref_001","doi-asserted-by":"crossref","unstructured":"Kouri, TT, Hofmann, W, Falbo, R, Oyaert, M, Schubert, S, Gertsen, JB, et al.. 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