{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T19:27:32Z","timestamp":1792783652302,"version":"4.5.0"},"reference-count":30,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T00:00:00Z","timestamp":1792108800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T00:00:00Z","timestamp":1792108800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100003052","name":"Ministry of Trade, Industry and Energy","doi-asserted-by":"publisher","award":["RS-2024-00403681"],"award-info":[{"award-number":["RS-2024-00403681"]}],"id":[{"id":"10.13039\/501100003052","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Korea Medical Device Development Fundation","award":["RS-2026-25538287"],"award-info":[{"award-number":["RS-2026-25538287"]}],"id":[{"id":"https:\/\/ror.org\/03g98ap29","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Blood Res."],"published-print":{"date-parts":[[2026,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>The sensitivity of real-time quantitative reverse-transcription polymerase chain reaction (RT-qPCR) for detecting measurable residual disease (MRD) in patients with chronic myeloid leukemia (CML) who have achieved a deep molecular response is limited. We validated a digital PCR (dPCR) assay (LQ Check BCR::ABL1 Major %IS Kit) for MRD quantification.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Validation was performed according to CLSI guidelines EP17-A2, EP06, EP05-A3, and EP07 using\n                      <jats:italic>BCR::ABL1<\/jats:italic>\n                      -positive and -negative materials and the World Health Organization (WHO) 1st International Standard. A nonparametric analysis of the limit of blank was used to establish a positivity cutoff of\u2009\u2265\u20092 droplets. The limit of detection (LoD) was verified using a detection criterion of\u2009\u2265\u200995%, and the limit of quantitation (LoQ) was defined as the lowest level meeting\u2009\u2265\u200995% detection and a study-defined %CV of\u2009\u2264\u200976%. Clinical validation included 72 CML specimens for molecular response (MR) category comparisons and 67 specimens for paired quantitative comparisons.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The LoD and LoQ were both 0.0025% on the International Scale (IS) with a detection rate of 95.8%. The assay showed linearity over 5 logs (R\n                      <jats:sup>2<\/jats:sup>\n                      \u2009=\u20090.9916\u20130.9972), within-run %CV\u2009\u2264\u20091.52%, cross-condition %CV\u2009\u2264\u20092.76%, and WHO-traceable accuracy. In 67 paired specimens, the correlation coefficient was r\u2009=\u20090.9740, with a Passing\u2013Bablok slope of 1.0189, intercept of\u2009\u22120.2552, and Bland\u2013Altman mean bias of 0.2266. Among the 72 specimens, dPCR classified 20 as having a deeper MR than RT-qPCR. Reproducibility was characterized by r\u2009=\u20090.99 and a mean bias of 0.0967. Whole blood was preferably processed within 48\u00a0h, with processing at 72\u00a0h considered acceptable only when\n                      <jats:italic>BCR<\/jats:italic>\n                      QC criteria were met.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>\n                      The LQ Check BCR::ABL1 Major %IS Kit enabled sensitive, precise, and reproducible\n                      <jats:italic>BCR::ABL1<\/jats:italic>\n                      quantification at MR4.6. The clinical significance of a deeper MR classification using dPCR, particularly for treatment-free remission, requires longitudinal validation.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s44313-026-00188-5","type":"journal-article","created":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T17:56:33Z","timestamp":1792173393000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Next-generation digital polymerase chain reaction assay for BCR::ABL1 in chronic myeloid leukemia: comprehensive validation for standardized measurable residual disease detection"],"prefix":"10.1007","volume":"61","author":[{"given":"Yong-Hwi","family":"Kim","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Min-Sik","family":"Jang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shin-Hyun","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"In-Young","family":"Roh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bong-Suk","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyung-Mi","family":"Kee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Soo-Hyun","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dong-Wook","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jae-Hoon","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,10,16]]},"reference":[{"key":"188_CR1","doi-asserted-by":"publisher","first-page":"21","DOI":"10.1186\/s40880-016-0108-0","volume":"4","author":"ZJ Kang","year":"2016","unstructured":"Kang ZJ, Liu YF, Xu LZ, Long ZJ, Huang D, Yang Y, et al. 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Digital PCR can provide improved BCR-ABL1 detection in chronic myeloid leukemia patients in deep molecular response and sensitivity of standard quantitative methods using EAC assays. Pract Lab Med. 2021;25:e00210. https:\/\/doi.org\/10.1016\/j.plabm.2021.e00210.","journal-title":"Pract Lab Med"},{"key":"188_CR30","doi-asserted-by":"publisher","first-page":"109","DOI":"10.1016\/j.jmoldx.2024.11.003","volume":"27","author":"C Kockerols","year":"2025","unstructured":"Kockerols C, Valk PJM, Hogenbirk P, Cornelissen JJ, Westerweel PE. BCR::ABL1 deep molecular response quantification and transcript type identification in chronic myeloid leukemia using a US Food and Drug Administration-approved droplet-based digital PCR assay. J Mol Diagn. 2025;27:109\u201318. https:\/\/doi.org\/10.1016\/j.jmoldx.2024.11.003.","journal-title":"J Mol Diagn"}],"container-title":["Blood Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s44313-026-00188-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s44313-026-00188-5","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s44313-026-00188-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T17:56:35Z","timestamp":1792173395000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s44313-026-00188-5"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10,16]]},"references-count":30,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2026,12]]}},"alternative-id":["188"],"URL":"https:\/\/doi.org\/10.1007\/s44313-026-00188-5","relation":{},"ISSN":["2287-979X","2288-0011"],"issn-type":[{"value":"2287-979X","type":"print"},{"value":"2288-0011","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,16]]},"assertion":[{"value":"11 May 2026","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"28 September 2026","order":2,"name":"revised","label":"Revised","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"5 October 2026","order":3,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"16 October 2026","order":4,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"This study was conducted in accordance with the principles of the Declaration of Helsinki. This study was approved by the Institutional Review Boards of GC Labs (IRB No. GCL-2024-2024-06), and Uijeongbu Eulji Medical Center (IRB Nos. UEMC 2022-01-019 and UEMC 2025-04-011). To evaluate clinical performance and reproducibility, anonymized total RNA samples were retrospectively obtained from biobanks (IRB Nos. GCL-2024-2024-06 and UEMC 2022-01-019), and the requirement for informed consent was waived due to the retrospective and anonymized nature of the study. For whole-blood stability testing, peripheral blood samples were collected from 15 adult patients using a prospective recruitment process (IRB No. UEMC 2025-04-011), and informed consent was obtained from all individual participants included in this part of the study.","order":1,"name":"Ethics","label":"Ethics approval and consent to participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors affirm that the human research participants provided informed consent for the publication of anonymized data and findings related to this study.","order":2,"name":"Ethics","label":"Consent for publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"YHK, MSJ, JHK, and BSK are current employees of BioTNS Co., Ltd. Sh.K. and IYR were employees of BioTNS Co., Ltd. at the time the study was conducted. The LQ Check BCR::ABL1 Major %IS Kit evaluated in this study was developed by BioTNS Co., Ltd. The remaining authors (KMK, So.K., and DWK) declare no competing interests.","order":3,"name":"Ethics","label":"Competing interests","group":{"name":"EthicsHeading","label":"Declarations"}}],"article-number":"67"}}