{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T14:19:51Z","timestamp":1784297991668,"version":"3.55.0"},"reference-count":18,"publisher":"MDPI AG","issue":"18","license":[{"start":{"date-parts":[[2025,9,13]],"date-time":"2025-09-13T00:00:00Z","timestamp":1757721600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Universities of Naples, Turin, Bologna, and Pisa"},{"name":"Cepheid"}],"content-domain":{"domain":["www.mdpi.com"],"crossmark-restriction":true},"short-container-title":["IJMS"],"abstract":"<jats:p>Chronic myeloid leukemia (CML) is a clonal myeloproliferative disorder caused by the BCR::ABL1 fusion gene, resulting from a reciprocal translocation between chromosomes 22 and 9. Quantification of BCR::ABL1 transcript levels in peripheral blood by RT-qPCR represents the gold standard for molecular response (MR) monitoring, providing essential clinical information on treatment efficacy. Xpert\u00ae BCR-ABL Ultra is a fully automated in vitro diagnostic test that quantitatively detects e13a2 and e14a2 BCR::ABL1 transcripts using a single-use cartridge that integrates RNA extraction, cDNA synthesis, nested real-time PCR, and signal detection within a rapid, closed, and user-friendly system. In this study, we evaluated Xpert\u00ae BCR-ABL Ultra as an alternative to validated systems currently used by four highly specialized Italian laboratories affiliated with the Italian national laboratory network for CML. A total of 129 peripheral blood samples from CML patients at various disease stages, along with two external quality control materials, were analyzed. We assessed the test\u2019s repeatability, specificity, and stability. Concordance of BCR::ABL1%IS values generated by the different methods was evaluated using EUTOS criteria and Bland\u2013Altman analysis. Finally, MR value concordance was analyzed based on European LeukemiaNet recommendations or calculated using the formula 2 \u2212 log10(BCR::ABL1%IS). Xpert\u00ae BCR-ABL Ultra demonstrated high repeatability and stability. The BCR::ABL1%IS values obtained with this assay showed strong concordance with those generated by local reference methods, and MR classifications were consistent across platforms. These findings confirm the robustness, accuracy, and efficiency of the Xpert\u00ae BCR-ABL Ultra assay, supporting its use as a reliable alternative to currently validated systems for the routine clinical monitoring of CML patients.<\/jats:p>","DOI":"10.3390\/ijms26188932","type":"journal-article","created":{"date-parts":[[2025,9,16]],"date-time":"2025-09-16T07:33:02Z","timestamp":1758007982000},"page":"8932","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["An Automated Cartridge-Based Microfluidic System for Real-Time Quantification of BCR::ABL1 Transcripts in Chronic Myeloid Leukemia: An Italian Experience"],"prefix":"10.3390","volume":"26","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-8657-1187","authenticated-orcid":false,"given":"Alice Costanza","family":"Danzero","sequence":"first","affiliation":[{"name":"Department of Clinical and Biological Sciences, Turin University, 10043 Orbassano, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enrico Marco","family":"Gottardi","sequence":"additional","affiliation":[{"name":"Department of Clinical and Biological Sciences, Turin University, 10043 Orbassano, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0744-5734","authenticated-orcid":false,"given":"Fabrizio","family":"Quarantelli","sequence":"additional","affiliation":[{"name":"Oncologic Hematology and Cytogenetics Laboratory, CEINGE Advanced Biotechnology \u201cFranco Salvatore\u201d, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ciro","family":"Del Prete","sequence":"additional","affiliation":[{"name":"Oncologic Hematology and Cytogenetics Laboratory, CEINGE Advanced Biotechnology \u201cFranco Salvatore\u201d, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandra","family":"Potenza","sequence":"additional","affiliation":[{"name":"Oncologic Hematology and Cytogenetics Laboratory, CEINGE Advanced Biotechnology \u201cFranco Salvatore\u201d, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia","family":"Venturi","sequence":"additional","affiliation":[{"name":"\u201cSer\u00e0gnoli\u201d Institute of Hematology, IRCCS University Hospital of Bologna, 40138 Bologna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5835-5638","authenticated-orcid":false,"given":"Paola","family":"Berchialla","sequence":"additional","affiliation":[{"name":"Department of Clinical and Biological Sciences, Turin University, 10043 Orbassano, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca","family":"Guerrini","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine, Hematology, University of Pisa, 56126 Pisa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clara","family":"Bono","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine, Hematology, University of Pisa, 56126 Pisa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emanuela","family":"Ottaviani","sequence":"additional","affiliation":[{"name":"\u201cSer\u00e0gnoli\u201d Institute of Hematology, IRCCS University Hospital of Bologna, 40138 Bologna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Galimberti","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine, Hematology, University of Pisa, 56126 Pisa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carmen","family":"Fava","sequence":"additional","affiliation":[{"name":"Department of Clinical and Biological Sciences, Turin University, 10043 Orbassano, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7021-0367","authenticated-orcid":false,"given":"Barbara","family":"Izzo","sequence":"additional","affiliation":[{"name":"Department of Molecular Medicine and Medical Biotechnology, University of Naples \u201cFederico II\u201d and CEINGE Advanced Biotechnology \u201cFranco Salvatore\u201d, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,9,13]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"711","DOI":"10.1046\/j.1365-2141.1998.01033.x","article-title":"Expression of p210 and p190 BCR-ABL due to alternative splicing in chronic myelogenous leukemia","volume":"103","author":"Lichty","year":"1998","journal-title":"Br. 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