{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,8]],"date-time":"2026-06-08T06:00:31Z","timestamp":1780898431229,"version":"3.54.1"},"reference-count":33,"publisher":"MDPI AG","issue":"11","license":[{"start":{"date-parts":[[2026,6,5]],"date-time":"2026-06-05T00:00:00Z","timestamp":1780617600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["IJMS"],"abstract":"<jats:p>Next-generation sequencing (NGS) clonality assessment has the potential to overcome the conventional limitations of PCR-based methods. This study aimed at comparing the performance and concordance of the EuroClonality-NGS approach and the LymphoTrack\u00ae Dx assay for immunoglobulin (IG)\/T-cell receptor (TR)-marker identification at diagnosis. Across four quality-control rounds, six Italian laboratories analyzed 23 acute lymphoblastic leukemia (ALL) and five chronic lymphocytic leukemia (CLL) cases. Overall, 171 rearrangements were identified; 80.7% were detected by both methods. Among shared targets, the concordance was 89.1%, with a higher agreement for IG (IGH 100%\u2013IGK 92.1%) than for TR loci (TRG 78.9%\u2013TRB 81.8%). Bland\u2013Altman analysis indicated no statistically significant systematic bias between methods [mean bias 1.99% (95% CI: \u22125.29 to +1.31%)]. The Spearman correlation was \u03c1 = 0.680 (p &lt; 0.001). Discordances (10.9%) rarely yielded suitable sensitive PCR assays for disease monitoring (20%) and were never the sole marker in individual patients. In larger independent cohorts, similar rates of no-marker cases were observed (~4\u20135% in adults), with higher frequencies in T-ALL and no association with blast percentage (Spearman\u2019s \u03c1 = 0.447, p = 0.450 in adults and \u03c1 = 0.700, p = 0.188 in childhood). These findings support the reliability of both methods for diagnostic screening, while highlighting locus-specific variability and the importance of multi-target identification.<\/jats:p>","DOI":"10.3390\/ijms27115115","type":"journal-article","created":{"date-parts":[[2026,6,5]],"date-time":"2026-06-05T08:43:04Z","timestamp":1780648984000},"page":"5115","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Comparative Analysis Between the EuroClonality-NGS Approach and the LymphoTrack\u00ae Dx Assay for IG\/TR Marker Screening in Lymphoid Leukemias: A Campus ALL Study"],"prefix":"10.3390","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7909-8642","authenticated-orcid":false,"given":"Irene","family":"Della Starza","sequence":"first","affiliation":[{"name":"Hematology, Department of Translational and Precision Medicine, Sapienza University, 00161 Rome, Italy"},{"name":"AIL Roma ODV, 00161 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4736-7171","authenticated-orcid":false,"given":"Vittorio","family":"Bellomarino","sequence":"additional","affiliation":[{"name":"Hematology, Department of Translational and Precision Medicine, Sapienza University, 00161 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariangela","family":"Di Trani","sequence":"additional","affiliation":[{"name":"Hematology, Department of Translational and Precision Medicine, Sapienza University, 00161 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8090-3880","authenticated-orcid":false,"given":"Luca Vincenzo","family":"Cappelli","sequence":"additional","affiliation":[{"name":"Hematology, Department of Translational and Precision Medicine, Sapienza University, 00161 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0374-1536","authenticated-orcid":false,"given":"Orietta","family":"Spinelli","sequence":"additional","affiliation":[{"name":"Hematology and Bone Marrow Transplant Unit, Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4353-2210","authenticated-orcid":false,"given":"Roberta","family":"Cavagna","sequence":"additional","affiliation":[{"name":"Hematology and Bone Marrow Transplant Unit, Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy"},{"name":"FROM Research Foundation, Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manuela","family":"Tosi","sequence":"additional","affiliation":[{"name":"Hematology and Bone Marrow Transplant Unit, Ospedale Papa Giovanni XXIII, 24127 Bergamo, 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Biotechnologies, University of Naples Federico II, 80145 Naples, 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":"CEINGE Advanced Biotechnologies, University of Naples Federico II, 80145 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-9233-2998","authenticated-orcid":false,"given":"Alessandra","family":"Potenza","sequence":"additional","affiliation":[{"name":"CEINGE Advanced Biotechnologies, University of Naples Federico II, 80145 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matilde Francesca","family":"Caradonna","sequence":"additional","affiliation":[{"name":"Tettamanti Center, Fondazione IRCCS San Gerardo Dei Tintori, 20900 Monza, 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