{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T07:06:43Z","timestamp":1780384003918,"version":"3.54.1"},"reference-count":25,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T00:00:00Z","timestamp":1780272000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T00:00:00Z","timestamp":1780272000000},"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":["Transfusion"],"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n The aim of this study was to investigate a CD34 expression assay as an additional tool for the total nucleated cell (TNC) count assessment in bone marrow harvest (BMH) obtained from healthy donors.<\/jats:p>\n <\/jats:sec>\n \n Study Design and Methods<\/jats:title>\n \n Samples obtained from bone marrow donors (\n n<\/jats:italic>\n \u2009=\u200971) were analyzed for CD34 expression using a digital PCR assay. The assay was extensively validated and the obtained data was correlated with standard BMH assessment methods such as TNC counts performed using a hematology analyzer and CD34 cell count measured with flow cytometry.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n The digital PCR CD34 assay showed a strong correlation with the TNC count (Spearman's\n r<\/jats:italic>\n s 0.87, 95% CI: 0.78\u20130.92,\n p<\/jats:italic>\n \u2009<\u2009.001) and also with the CD34 cell count assessed by flow cytometry (Spearman's\n r<\/jats:italic>\n s 0.91, 95% CI: 0.84\u20130.94,\n p<\/jats:italic>\n \u2009<\u2009.001). To analyze the diagnostic performance of the assay, the true\u2010positive rate (sensitivity) and the false\u2010positive rate (1\u2009\u2212\u2009specificity) were plotted in a receiver\u2010operating characteristic (ROC) space.\n <\/jats:p>\n \n The ROC curve showed an area under the curve (AUC) of 0.96 (95% confidence interval 0.91\u20131.01,\n p<\/jats:italic>\n \u2009<\u2009.005). The CD34 NCN per kilogram of recipient body weight threshold of 0.54 resulted in a sensitivity of 0.91, a specificity of 0.96, a positive and negative predictive value of 0.97 and 0.91, respectively.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n The CD34 expression assay here described can be used as an additional tool for TNC count estimation after BMH.<\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/trf.70267","type":"journal-article","created":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T06:19:14Z","timestamp":1780381154000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Performance evaluation of a\n CD34<\/scp>\n expression assay by digital\n PCR<\/scp>\n in bone marrow harvest from healthy donors"],"prefix":"10.1111","author":[{"given":"Miguel","family":"Waterhouse","sequence":"first","affiliation":[{"name":"Department of Hematology, Oncology and Stem Cell Transplantation Freiburg University Medical Center Freiburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anja","family":"Kaufmann","sequence":"additional","affiliation":[{"name":"Department of Hematology, Oncology and Stem Cell Transplantation Freiburg University Medical Center Freiburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martina","family":"David","sequence":"additional","affiliation":[{"name":"Department of Hematology, Oncology and Stem Cell Transplantation Freiburg University Medical Center Freiburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabine","family":"Enger","sequence":"additional","affiliation":[{"name":"Department of Hematology, Oncology and Stem Cell Transplantation Freiburg University Medical Center Freiburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melanie","family":"Sieder","sequence":"additional","affiliation":[{"name":"Department of Hematology, Oncology and Stem Cell Transplantation Freiburg University Medical Center Freiburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Darina","family":"Siegmund","sequence":"additional","affiliation":[{"name":"Department of Hematology, Oncology and Stem Cell Transplantation Freiburg University Medical Center Freiburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Milena","family":"Pantic","sequence":"additional","affiliation":[{"name":"Department of Hematology, Oncology and Stem Cell Transplantation Freiburg University Medical Center Freiburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Justyna","family":"Rawluk","sequence":"additional","affiliation":[{"name":"Department of Hematology, Oncology and Stem Cell Transplantation Freiburg University Medical Center Freiburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6565-3393","authenticated-orcid":false,"given":"Robert","family":"Zeiser","sequence":"additional","affiliation":[{"name":"Department of Hematology, Oncology and Stem Cell Transplantation Freiburg University Medical Center Freiburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia","family":"Wehr","sequence":"additional","affiliation":[{"name":"Department of Hematology, Oncology and Stem Cell Transplantation Freiburg University Medical Center Freiburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0813-3444","authenticated-orcid":false,"given":"Ralph","family":"W\u00e4sch","sequence":"additional","affiliation":[{"name":"Department of Hematology, Oncology and Stem Cell Transplantation Freiburg University Medical Center Freiburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Justus","family":"Duyster","sequence":"additional","affiliation":[{"name":"Department of Hematology, Oncology and Stem Cell Transplantation Freiburg University Medical Center Freiburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00fcrgen","family":"Finke","sequence":"additional","affiliation":[{"name":"Department of Hematology, Oncology and Stem Cell Transplantation Freiburg University Medical Center Freiburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chrissoula","family":"Kiote\u2010Schmidt","sequence":"additional","affiliation":[{"name":"Department of Hematology, Oncology and Stem Cell Transplantation Freiburg University Medical Center Freiburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,6,1]]},"reference":[{"issue":"8858","key":"e_1_2_11_2_1","doi-asserted-by":"crossref","first-page":"1482","DOI":"10.1016\/0140-6736(93)90929-B","article-title":"Peripheral blood stem cells as an alternative to marrow for allogeneic transplantation","volume":"341","author":"Russell NH","year":"1993","journal-title":"Lancet"},{"issue":"16","key":"e_1_2_11_3_1","doi-asserted-by":"crossref","first-page":"3685","DOI":"10.1200\/JCO.2001.19.16.3685","article-title":"Acute and chronic graft\u2010versus\u2010host disease after allogeneic peripheral\u2010blood stem\u2010cell and bone marrow transplantation: a meta\u2010analysis","volume":"19","author":"Cutler C","year":"2001","journal-title":"J Clin Oncol"},{"issue":"12","key":"e_1_2_11_4_1","doi-asserted-by":"crossref","first-page":"4705","DOI":"10.1182\/blood.V90.12.4705","article-title":"Allogeneic peripheral blood stem cell transplantation may be associated with a high risk of chronic graft\u2010versus\u2010host disease","volume":"90","author":"Storek J","year":"1997","journal-title":"Blood"},{"issue":"10","key":"e_1_2_11_5_1","doi-asserted-by":"crossref","first-page":"638.e1","DOI":"10.1016\/j.jtct.2023.07.003","article-title":"Harvest quality, nucleated cell dose and clinical outcomes in bone marrow transplantation: a retrospective study","volume":"29","author":"Mamo T","year":"2023","journal-title":"Transplant Cell Ther"},{"issue":"11","key":"e_1_2_11_6_1","first-page":"3323","article-title":"Effect of nucleated marrow cell dose on relapse and survival in identical twin bone marrow transplants for leukemia","volume":"95","author":"Barrett AJ","year":"2000","journal-title":"Blood"},{"issue":"8","key":"e_1_2_11_7_1","doi-asserted-by":"crossref","first-page":"3043","DOI":"10.1182\/blood-2003-03-0665","article-title":"Marrow versus peripheral blood for geno\u2010identical allogeneic stem cell transplantation in acute myelocytic leukemia: influence of dose and stem cell source shows better outcome with rich marrow","volume":"102","author":"Gorin NC","year":"2003","journal-title":"Blood"},{"issue":"21","key":"e_1_2_11_8_1","doi-asserted-by":"crossref","first-page":"4324","DOI":"10.1200\/JCO.2002.11.058","article-title":"Relevance of bone marrow cell dose on allogeneic transplantation outcomes for patients with acute myeloid leukemia in first complete remission: results of a European survey","volume":"20","author":"Rocha V","year":"2002","journal-title":"J Clin Oncol"},{"issue":"2","key":"e_1_2_11_9_1","doi-asserted-by":"crossref","first-page":"219","DOI":"10.1002\/cyto.b.21519","article-title":"Visualization of cell composition and maturation in the bone marrow using 10\u2010color flow cytometry and radar plots","volume":"94","author":"Jafari K","year":"2018","journal-title":"Cytometry B Clin Cytom"},{"issue":"3","key":"e_1_2_11_10_1","doi-asserted-by":"crossref","first-page":"315","DOI":"10.1016\/j.transci.2010.09.020","article-title":"The effect of CD34 count and clonogenic potential of hematopoietic stem cells on engraftment","volume":"43","author":"Sar\u0131 T","year":"2010","journal-title":"Transfus Apher Sci"},{"issue":"10","key":"e_1_2_11_11_1","doi-asserted-by":"crossref","first-page":"3961","DOI":"10.1182\/blood.V86.10.3961.bloodjournal86103961","article-title":"An analysis of engraftment kinetics as a function of the CD34 content of peripheral blood progenitor cell collections in 692 patients after the administration of myeloablative chemotherapy","volume":"86","author":"Weaver CH","year":"1995","journal-title":"Blood"},{"issue":"5","key":"e_1_2_11_12_1","doi-asserted-by":"crossref","first-page":"515","DOI":"10.3343\/alm.2022.42.5.515","article-title":"Unreliable automated complete blood count results: causes, recognition, and resolution","volume":"42","author":"Gulati G","year":"2022","journal-title":"Ann Lab Med"},{"issue":"5","key":"e_1_2_11_13_1","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0301845","article-title":"A comparative study of blood cell counts in four automated hematology analyzers: an evaluation of the impact of preanalytical factors","volume":"19","author":"\u00c5strand A","year":"2024","journal-title":"PLoS One"},{"issue":"9","key":"e_1_2_11_14_1","doi-asserted-by":"crossref","first-page":"785","DOI":"10.1038\/sj.bmt.1700984","article-title":"Extended duration between harvest and re\u2010infusion of human bone marrow stored at room temperature","volume":"20","author":"Lipton JH","year":"1997","journal-title":"Bone Marrow Transplant"},{"issue":"1","key":"e_1_2_11_15_1","first-page":"265","article-title":"Circulating clonal cells in multiple myeloma do not express CD34 mRNA, as measured by single\u2010cell and real\u2010time RT\u2010PCR assays","volume":"105","author":"Rasmussen T","year":"1999","journal-title":"Br J Haematol"},{"key":"e_1_2_11_16_1","volume-title":"Evaluation of detection capability for clinical laboratory measurement procedures (EP17\u2010A2)","author":"Clinical and Laboratory Standards Institute","year":"2012"},{"key":"e_1_2_11_17_1","volume-title":"Guidance document on multiplex real\u2010time PCR methods","author":"Grohmann L","year":"2021"},{"key":"e_1_2_11_18_1","volume-title":"Expression of measurement uncertainty in laboratory medicine (EP29\u2010A)","author":"Clinical and Laboratory Standards Institute","year":"2012"},{"issue":"5","key":"e_1_2_11_19_1","doi-asserted-by":"crossref","first-page":"1525","DOI":"10.1182\/blood-2002-01-0048","article-title":"A randomized multicenter comparison of bone marrow and peripheral blood in recipients of matched sibling allogeneic transplants for myeloid malignancies","volume":"100","author":"Couban S","year":"2002","journal-title":"Blood"},{"issue":"1","key":"e_1_2_11_20_1","doi-asserted-by":"crossref","DOI":"10.1038\/s41598-022-22339-1","article-title":"Widely applicable, extended flow cytometric stem cell enumeration panel for quality control of advanced cellular products","volume":"12","author":"Haussmann K","year":"2022","journal-title":"Sci Rep"},{"issue":"3","key":"e_1_2_11_21_1","doi-asserted-by":"crossref","first-page":"213","DOI":"10.1089\/scd.1.1996.5.213","article-title":"The ISHAGE guidelines for CD34+ cell determination by flow cytometry. International Society of Hematotherapy and Graft Engineering","volume":"5","author":"Sutherland DR","year":"1996","journal-title":"J Hematother"},{"issue":"7","key":"e_1_2_11_22_1","first-page":"875","article-title":"Progenitor cell trafficking in physiologic conditions and in myeloproliferative diseases: quantification of CD34+ cells by polymerase chain reaction","volume":"90","author":"Oppliger Leibundgut E","year":"2005","journal-title":"Haematologica"},{"issue":"5","key":"e_1_2_11_23_1","doi-asserted-by":"crossref","first-page":"1533","DOI":"10.1111\/trf.16374","article-title":"The impact of donor total estimated blood volume on nucleated cell yield in bone marrow harvests for hematopoietic stem cell transplantation","volume":"61","author":"Rennert W","year":"2021","journal-title":"Transfusion"},{"issue":"28","key":"e_1_2_11_24_1","doi-asserted-by":"crossref","first-page":"3144","DOI":"10.1200\/JCO.2014.59.1339","article-title":"Prediction of allogeneic hematopoietic stem\u2010cell transplantation mortality 100\u2009days after transplantation using a machine learning algorithm: a European Group for Blood and Marrow Transplantation Acute Leukemia Working Party Retrospective Data Mining Study","volume":"33","author":"Shouval R","year":"2015","journal-title":"J Clin Oncol"},{"issue":"10","key":"e_1_2_11_25_1","doi-asserted-by":"crossref","first-page":"1309","DOI":"10.1002\/ajh.26671","article-title":"Time\u2010dependent prediction of mortality and cytomegalovirus reactivation after allogeneic hematopoietic cell transplantation using machine learning","volume":"97","author":"Eisenberg L","year":"2022","journal-title":"Am J Hematol"},{"key":"e_1_2_11_26_1","doi-asserted-by":"crossref","DOI":"10.1016\/j.trim.2025.102211","article-title":"Pre\u2010transplant and transplant parameters predict long\u2010term survival after hematopoietic cell transplantation using machine learning","volume":"90","author":"Asteris PG","year":"2025","journal-title":"Transpl Immunol"}],"container-title":["Transfusion"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/trf.70267","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/trf.70267","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/trf.70267","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T06:19:18Z","timestamp":1780381158000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/trf.70267"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,6,1]]},"references-count":25,"alternative-id":["10.1111\/trf.70267"],"URL":"https:\/\/doi.org\/10.1111\/trf.70267","archive":["Portico"],"relation":{},"ISSN":["0041-1132","1537-2995"],"issn-type":[{"value":"0041-1132","type":"print"},{"value":"1537-2995","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,6,1]]},"assertion":[{"value":"2026-03-17","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-05-08","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-06-01","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"trf.70267"}}