{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,25]],"date-time":"2026-07-25T11:15:34Z","timestamp":1784978134467,"version":"3.55.0"},"reference-count":30,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2024,3,25]],"date-time":"2024-03-25T00:00:00Z","timestamp":1711324800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100002648","name":"Catholic University of Korea","doi-asserted-by":"publisher","award":["ZC22SISI0441"],"award-info":[{"award-number":["ZC22SISI0441"]}],"id":[{"id":"10.13039\/501100002648","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Laboratory Analysis"],"published-print":{"date-parts":[[2024,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Accurate quantification of the <jats:italic>BCR::ABL1<\/jats:italic> transcripts is essential for measurable residual disease (MRD) monitoring in chronic myeloid leukemia (CML) after tyrosine kinase inhibitor (TKI) treatment. This study evaluated the newly developed digital real\u2010time PCR method, Dr. PCR, as an alternative reverse transcription\u2010PCR (qRT\u2010PCR) for MRD detection.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The performance of Dr. PCR was assessed using reference and clinical materials. Precision, linearity, and correlation with qRT\u2010PCR were evaluated. MRD levels detected by Dr. PCR were compared with qRT\u2010PCR, and practical advantages were investigated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Dr. PCR detected MRD up to 0.0032%<jats:sup>IS<\/jats:sup> (MR4.5) with excellent precision and linearity and showed a strong correlation with qRT\u2010PCR results. Notably, Dr. PCR identified higher levels of MRD in 12.7% (29\/229) of patients than qRT\u2010PCR, including six cases of MR4, which is a critical level for TKI discontinuation. Dr. PCR also allowed for sufficient <jats:italic>ABL1<\/jats:italic> copies in all cases, while qRT\u2010PCR necessitated multiple repeat tests in 3.5% (8\/229) of cases.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Our study provides a body of evidence supporting the clinical application of Dr. PCR as a rapid and efficient method for assessing MRD in patients with CML under the current treatment regimen.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcla.25034","type":"journal-article","created":{"date-parts":[[2024,3,25]],"date-time":"2024-03-25T11:30:37Z","timestamp":1711366237000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Analytical Performance Evaluation of a Digital Real\u2010Time <scp>PCR<\/scp> for Quantifying Major <i><scp>BCR<\/scp>::<scp>ABL1<\/scp><\/i> Transcripts"],"prefix":"10.1002","volume":"38","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1476-6221","authenticated-orcid":false,"given":"Soo Jung","family":"Lee","sequence":"first","affiliation":[{"name":"Department of Laboratory Medicine Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jong\u2010Mi","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ari","family":"Ahn","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine, Incheon St. Mary's Hospital, College of Medicine The Catholic University of Korea  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sung\u2010Eun","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Hematology, Catholic Hematology Hospital, Seoul St. Mary's Hospital, College of Medicine The Catholic University of Korea  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuna","family":"Hong","sequence":"additional","affiliation":[{"name":"Catholic Genetic Laboratory Center, Seoul St. Mary's Hospital, College of Medicine The Catholic University of Korea  Seoul Korea"},{"name":"Department of Biomedicine &amp; Health Sciences, Graduate School The Catholic University of Korea  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gun Dong","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hyun\u2010Woo","family":"Song","sequence":"additional","affiliation":[{"name":"Bio Institute, Optolane Technologies Inc.  Pangyo Seong\u2010Nam\u2010Si Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Min\u2010Sik","family":"Song","sequence":"additional","affiliation":[{"name":"Bio Institute, Optolane Technologies Inc.  Pangyo Seong\u2010Nam\u2010Si Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seung\u2010Shick","family":"Shin","sequence":"additional","affiliation":[{"name":"Bio Institute, Optolane Technologies Inc.  Pangyo Seong\u2010Nam\u2010Si Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Myungshin","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea  Seoul Korea"},{"name":"Catholic Genetic Laboratory Center, Seoul St. Mary's Hospital, College of Medicine The Catholic University of Korea  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yonggoo","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea  Seoul Korea"},{"name":"Catholic Genetic Laboratory Center, Seoul St. Mary's Hospital, College of Medicine The Catholic University of Korea  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,3,25]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2013-05-501569"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41375-020-0776-2"},{"issue":"5","key":"e_1_2_10_4_1","first-page":"611","article-title":"NCCN Guidelines Updates: Discontinuing TKI Therapy in the Treatment of Chronic Myeloid Leukemia","volume":"17","author":"Shah N. 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