{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T03:09:01Z","timestamp":1773025741915,"version":"3.50.1"},"reference-count":22,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2022,5,25]],"date-time":"2022-05-25T00:00:00Z","timestamp":1653436800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Int J Lab Hematology"],"published-print":{"date-parts":[[2022,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>The reliable diagnosis of paroxysmal nocturnal haemoglobinuria (PNH) by flow cytometry is based on mandatory analysis of the erythroid, neutrophilic and monocytic lineages. In this study, we have evaluated the performance characteristics of a recently published immature red blood cell (iRBC) assay as a potential screening test for PNH by flow cytometry.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Intra\u2010 and inter\u2010assay imprecision were determined in five replicates of small, medium and large PNH iRBC clones. Analytical and functional sensitivity was assessed by performing spiking tests for five replicates. Thirty healthy donors and 441 PNH patients were tested for evaluation of clinical specificity, sensitivity, positive and negative predictive values.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Coefficients of variation (CV) for intra\u2010\/inter\u2010assay imprecision analyses were 1.31\/1.50, 3.19\/2.61 and 3.99\/1.58 for the big, medium and small clone sizes, respectively. Absolute values (100%) were found for both clinical specificity and sensitivity as well as for both positive and negative predictive values. The CV from 5 replicate results for 10 clustered events was 15.7%. The coefficient of determination (<jats:italic>r<\/jats:italic><jats:sup>2<\/jats:sup>), Pearson's correlation coefficient (<jats:italic>r<\/jats:italic>) and Bland\u2013Altman mean bias were 0.9436\/0.9234\/1.7 for PNH iRBC compared to PNH neutrophils and 0.9553\/0.9387\/2.1 for PNH iRBCs compared to PNH monocytes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Our results confirm very good performance characteristics, high analytical and functional sensitivity, absolute clinical specificity and sensitivity as well as favourable correlation between PNH iRBCs and both PNH neutrophils and monocytes, suggesting that this cost\u2010effective 3\u2010colour iRBC assay can be used as a reliable screening test for evaluation of small, medium and large PNH clones by flow cytometry.<\/jats:p><\/jats:sec>","DOI":"10.1111\/ijlh.13877","type":"journal-article","created":{"date-parts":[[2022,5,26]],"date-time":"2022-05-26T03:59:42Z","timestamp":1653537582000},"page":"868-874","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Validation of a single tube 3\u2010colour immature red blood cell screening assay for the detection and enumeration of small, medium and large paroxysmal nocturnal haemoglobinuria clones by flow cytometry"],"prefix":"10.1111","volume":"44","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0025-3131","authenticated-orcid":false,"given":"Iuri","family":"Marinov","sequence":"first","affiliation":[{"name":"Clinical Department Institute of Haematology and Blood Transfusion Prague Czech Republic"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen J.","family":"Richards","sequence":"additional","affiliation":[{"name":"Division of Haematology and Immunology Leeds Institute of Medical Research at St James's, University of Leeds Leeds UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adam","family":"Pe\u0161ek","sequence":"additional","affiliation":[{"name":"Clinical Department Institute of Haematology and Blood Transfusion Prague Czech Republic"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0237-3591","authenticated-orcid":false,"given":"Andrea J.","family":"Illingworth","sequence":"additional","affiliation":[{"name":"Dahl\u2010Chase Diagnostic Services Bangor Maine USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"D. Robert","family":"Sutherland","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Toronto General Hospital Toronto Ontario Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,5,25]]},"reference":[{"key":"e_1_2_8_2_1","first-page":"587","article-title":"Paroxysmal nocturnal haemoglobinuria","volume":"56","author":"Dacie JV","year":"2014","journal-title":"Proc R Soc Med"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V36.2.145.145"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1126\/science.7680492"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1172\/JCI114172"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1006\/bcmd.1998.0203"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2005-04-1717"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/cyto.b.20151"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/cyto.b.21023"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/cyto.b.21111"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/cyto.b.21610"},{"key":"e_1_2_8_12_1","doi-asserted-by":"crossref","first-page":"211","DOI":"10.1002\/cyto.b.20525","article-title":"Guidelines for the diagnosis and monitoring of paroxysmal nocturnal hemoglobinuria and related disorders by flow cytometry\u2014a consensus guideline","volume":"72","author":"Borowitz MJ","year":"2010","journal-title":"Cytometry Part B."},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/cyto.b.21609"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/cyto.b.21615"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/cyto.b.21626"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V86.4.1586.bloodjournal8641586"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2257.1991.tb00267.x"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/cyto.b.21030"},{"key":"e_1_2_8_19_1","first-page":"25","article-title":"The evaluation and comparative characteristic of detection of clone of paroxysmal nocturnal hemoglobinuria on iRBCs using the technique of flow cytometry","volume":"59","author":"Naumova EV","year":"2014","journal-title":"Klin Lab Diagn"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/cyto.b.21853"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/ijlh.12271"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1111\/ejh.12885"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1111\/ejh.12885"}],"container-title":["International Journal of Laboratory Hematology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/ijlh.13877","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/ijlh.13877","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/ijlh.13877","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,11,22]],"date-time":"2023-11-22T06:33:28Z","timestamp":1700634808000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/ijlh.13877"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,5,25]]},"references-count":22,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2022,10]]}},"alternative-id":["10.1111\/ijlh.13877"],"URL":"https:\/\/doi.org\/10.1111\/ijlh.13877","archive":["Portico"],"relation":{},"ISSN":["1751-5521","1751-553X"],"issn-type":[{"value":"1751-5521","type":"print"},{"value":"1751-553X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,5,25]]},"assertion":[{"value":"2022-01-11","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-04-29","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-05-25","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}