{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T21:35:11Z","timestamp":1792100111517,"version":"4.4.0"},"reference-count":32,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2013,6,1]],"date-time":"2013-06-01T00:00:00Z","timestamp":1370044800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"name":"Asuragen"},{"DOI":"10.13039\/100004336","name":"Novartis","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004336","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000276","name":"UK Department of Health","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100000276","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2013,6,1]]},"abstract":"<jats:sec>\n                  <jats:title>BACKGROUND<\/jats:title>\n                  <jats:p>Current guidelines for managing Philadelphia-positive chronic myeloid leukemia include monitoring the expression of the BCR-ABL1 (breakpoint cluster region\/c-abl oncogene 1, non-receptor tyrosine kinase) fusion gene by quantitative reverse-transcription PCR (RT-qPCR). Our goal was to establish and validate reference panels to mitigate the interlaboratory imprecision of quantitative BCR-ABL1 measurements and to facilitate global standardization on the international scale (IS).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>METHODS<\/jats:title>\n                  <jats:p>Four-level secondary reference panels were manufactured under controlled and validated processes with synthetic Armored RNA Quant molecules (Asuragen) calibrated to reference standards from the WHO and the NIST. Performance was evaluated in IS reference laboratories and with non\u2013IS-standardized RT-qPCR methods.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>RESULTS<\/jats:title>\n                  <jats:p>For most methods, percent ratios for BCR-ABL1 e13a2 and e14a2 relative to ABL1 or BCR were robust at 4 different levels and linear over 3 logarithms, from 10% to 0.01% on the IS. The intraassay and interassay imprecision was &amp;lt;2-fold overall. Performance was stable across 3 consecutive lots, in multiple laboratories, and over a period of 18 months to date. International field trials demonstrated the commutability of the reagents and their accurate alignment to the IS within the intra- and interlaboratory imprecision of IS-standardized methods.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>CONCLUSIONS<\/jats:title>\n                  <jats:p>The synthetic calibrator panels are robust, reproducibly manufactured, analytically calibrated to the WHO primary standards, and compatible with most BCR-ABL1 RT-qPCR assay designs. The broad availability of secondary reference reagents will further facilitate interlaboratory comparative studies and independent quality assessment programs, which are of paramount importance for worldwide standardization of BCR-ABL1 monitoring results and the optimization of current and new therapeutic approaches for chronic myeloid leukemia.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1373\/clinchem.2012.196477","type":"journal-article","created":{"date-parts":[[2013,3,7]],"date-time":"2013-03-07T21:55:26Z","timestamp":1362693326000},"page":"938-948","source":"Crossref","is-referenced-by-count":47,"title":["Establishment and Validation of Analytical Reference Panels for the Standardization of Quantitative BCR-ABL1 Measurements on the International Scale"],"prefix":"10.1093","volume":"59","author":[{"given":"Helen E","family":"White","sequence":"first","affiliation":[{"name":"National Genetics Reference Laboratory Wessex, Salisbury District Hospital, Salisbury, UK"},{"name":"Faculty of Medicine, University of Southampton, Southampton, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Hedges","sequence":"first","affiliation":[{"name":"Asuragen, Inc., Austin, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Israel","family":"Bendit","sequence":"first","affiliation":[{"name":"Department of Hematology and Hemotherapy, Medical School at University of S\u00e3o Paulo, S\u00e3o Paulo, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan","family":"Branford","sequence":"first","affiliation":[{"name":"Department of Molecular Pathology, SA Pathology and the University of Adelaide, Adelaide, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dolors","family":"Colomer","sequence":"first","affiliation":[{"name":"Unitat d'Hematopatologia, Hospital Clinic, Institut d'Investigacions Biom\u00e8diques August Pi i Sunyer, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Hochhaus","sequence":"first","affiliation":[{"name":"Abteilung H\u00e4matologie\/Onkologie, Klinik f\u00fcr Innere Medizin II, Universit\u00e4tsklinikum Jena, Jena, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timothy","family":"Hughes","sequence":"first","affiliation":[{"name":"Department of Hematology, SA Pathology and the University of Adelaide, Adelaide, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suzanne","family":"Kamel-Reid","sequence":"first","affiliation":[{"name":"Department of Pathology, University Health Network, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dong-Wook","family":"Kim","sequence":"first","affiliation":[{"name":"Cancer Research Institute, College of Medicine, Catholic University of Korea, Seoul, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vijay","family":"Modur","sequence":"first","affiliation":[{"name":"Novartis Oncology, Cambridge, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin C","family":"M\u00fcller","sequence":"first","affiliation":[{"name":"III Medizinische Klinik, Medizinische Fakult\u00e4t Mannheim der Universit\u00e4t Heidelberg, Mannheim, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katia B","family":"Pagnano","sequence":"first","affiliation":[{"name":"Hematology and Hemotherapy Center, University of Campinas, Campinas, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabrizio","family":"Pane","sequence":"first","affiliation":[{"name":"Division of Hematology, University of Naples Federico II, Naples, Italy"},{"name":"CEINGE, Biotecnologie Avanzate, Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jerry","family":"Radich","sequence":"first","affiliation":[{"name":"Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicholas CP","family":"Cross","sequence":"first","affiliation":[{"name":"National Genetics Reference Laboratory Wessex, Salisbury District Hospital, Salisbury, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emmanuel","family":"Labourier","sequence":"first","affiliation":[{"name":"Faculty of Medicine, University of Southampton, Southampton, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2013,6,1]]},"reference":[{"key":"2020022705314825200_B1","doi-asserted-by":"crossref","first-page":"6041","DOI":"10.1200\/JCO.2009.25.0779","article-title":"Chronic myeloid leukemia: an update of concepts and management recommendations of 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