{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,9]],"date-time":"2026-01-09T15:20:23Z","timestamp":1767972023046,"version":"3.49.0"},"reference-count":23,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2021,6,10]],"date-time":"2021-06-10T00:00:00Z","timestamp":1623283200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100011234","name":"Bio-Rad Laboratories","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100011234","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Br J Haematol"],"published-print":{"date-parts":[[2021,7]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>Measurement of BCR activator of RhoGEF and GTPase \u2010ABL proto\u2010oncogene 1, non\u2010receptor tyrosine kinase (<jats:italic>BCR\u2010ABL1<\/jats:italic>) mRNA levels by reverse transcription quantitative polymerase chain reaction (RTqPCR) has been critical to treatment protocols and clinical trials in chronic myeloid leukaemia; however, interlaboratory variation remains a significant issue. Reverse transcriptase droplet digital PCR (RTddPCR) has shown potential to improve testing but a large\u2010scale interlaboratory study is required to definitively establish this. In the present study, 10 <jats:italic>BCR\u2010ABL1<\/jats:italic>\u2010positive samples with levels ranging from molecular response (MR)<jats:sup>1\u00b70<\/jats:sup>\u2013MR<jats:sup>5\u00b70<\/jats:sup> were tested by 23 laboratories using RTddPCR with the QXDX BCR\u2010ABL %IS kit. A subset of participants tested the samples using RTqPCR. All 23 participants using RTddPCR detected <jats:italic>BCR\u2010ABL1<\/jats:italic> in all samples to MR<jats:sup>4\u00b70<\/jats:sup>. Detection rates for deep\u2010response samples were 95\u00b77% at MR<jats:sup>4\u00b75<\/jats:sup>, 78\u00b73% at MR<jats:sup>4\u00b77<\/jats:sup> and 87\u00b70% at MR<jats:sup>5\u00b70<\/jats:sup>. Interlaboratory coefficient of variation was indirectly proportional to <jats:italic>BCR\u2010ABL1<\/jats:italic> level ranging from 29\u00b73% to 69\u00b70%. Linearity ranged from 0\u00b79330 to 1\u00b7000 (average 0\u00b79936). When results were compared for the 11 participants who performed both RTddPCR and RTqPCR, RTddPCR showed a similar limit of detection to RTqPCR with reduced interlaboratory variation and better assay linearity. The ability to detect deep responses with RTddPCR, matched with an improved linearity and reduced interlaboratory variation will allow improved patient management, and is of particular importance for future clinical trials focussed on achieving and maintaining treatment\u2010free remission.<\/jats:p>","DOI":"10.1111\/bjh.17521","type":"journal-article","created":{"date-parts":[[2021,6,11]],"date-time":"2021-06-11T08:01:57Z","timestamp":1623398517000},"page":"53-60","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Assessment of droplet digital polymerase chain reaction for measuring <i>BCR\u2010ABL1<\/i> in chronic myeloid leukaemia in an international interlaboratory study"],"prefix":"10.1111","volume":"194","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8182-3057","authenticated-orcid":false,"given":"Stuart","family":"Scott","sequence":"first","affiliation":[{"name":"Sheffield Teaching Hospital NHS Foundation Trust, UK National External Quality Assessment Services (NEQAS) for Leucocyte Immunophenotyping Sheffield UK"},{"name":"Faculty of Medicine Dentistry and Health Department of Oncology and Metabolism University of Sheffield Sheffield UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ashley","family":"Cartwright","sequence":"additional","affiliation":[{"name":"Sheffield Teaching Hospital NHS Foundation Trust, UK National External Quality Assessment Services (NEQAS) for Leucocyte Immunophenotyping Sheffield UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sebastian","family":"Francis","sequence":"additional","affiliation":[{"name":"Department of Haematology Sheffield Teaching Hospitals NHS Foundation Trust Sheffield UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Liam","family":"Whitby","sequence":"additional","affiliation":[{"name":"Sheffield Teaching Hospital NHS Foundation Trust, UK National External Quality Assessment Services (NEQAS) for Leucocyte Immunophenotyping Sheffield UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A. Pia","family":"Sanzone","sequence":"additional","affiliation":[{"name":"Advanced Therapies National Institute for Biological Standards and Control Potters Bar UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andr\u00e9","family":"Mulder","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine University Medical Center Groningen, University of Groningen Groningen Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sara","family":"Galimberti","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine University of Pisa Pisa Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2728-7243","authenticated-orcid":false,"given":"Stephanie","family":"Dulucq","sequence":"additional","affiliation":[{"name":"Laboratory of Hematology University Hospital Centre Bordeaux Pessac France"},{"name":"University of Bordeaux INSERM U1218 Bordeaux France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carole","family":"Maut\u00e9","sequence":"additional","affiliation":[{"name":"Haematology Laboratory H\u00f4pital Saint\u2010Louis Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Calogero","family":"Lauricella","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine ASST Grande Ospedale Metropolitano Niguarda Milan Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew","family":"Salmon","sequence":"additional","affiliation":[{"name":"Wessex Regional Genetics Laboratory Salisbury District Hospital Salisbury UK"},{"name":"University of Southampton, School of Medicine Southampton UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susan","family":"Rose","sequence":"additional","affiliation":[{"name":"West Midlands Regional Genetics Laboratory Birmingham Women\u2019s and Children\u2019s Hospitals NHS Foundation Trust Birmingham UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Josh","family":"Willoughby","sequence":"additional","affiliation":[{"name":"Sheffield Diagnostic Genetics Service Sheffield Children\u2019s Hospital NHS Foundation Trust Sheffield UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nancy","family":"Boeckx","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine University Hospitals Leuven Leuven Belgium"},{"name":"Department of Oncology KU Leuven Leuven Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Niels","family":"Pallisgaard","sequence":"additional","affiliation":[{"name":"Department of Surgical Pathology Zealand University Hospital Roskilde Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jacqueline","family":"Maier","sequence":"additional","affiliation":[{"name":"Department of Transfusion Medicine University Hospital Leipzig Leipzig Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elisabeth O.","family":"Leibundgut","sequence":"additional","affiliation":[{"name":"Department of Haematology Inselspital, Bern University Hospital Bern Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hana","family":"Zizkova","sequence":"additional","affiliation":[{"name":"Department of Molecular Genetics Institute of Hematology and Blood Transfusion Praha Czech Republic"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Liuh","family":"Ling Goh","sequence":"additional","affiliation":[{"name":"Personalized Medicine Service Tan Tock Seng Hospital Singapore Singapore"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chinh","family":"Duong","sequence":"additional","affiliation":[{"name":"Genetics and Molecular Biology National Institute of Hematology and Blood Transfusion Hanoi Vietnam"},{"name":"Department of Hematology and Blood Transfusion University of Medicine and Pharmacy, Vietnam National University Hanoi Vietnam"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wing F.","family":"Tang","sequence":"additional","affiliation":[{"name":"Department of Pathology Division of Haematology Queen Mary Hospital Hong Kong Hong Kong"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1259-2205","authenticated-orcid":false,"given":"Edmond","family":"Ma","sequence":"additional","affiliation":[{"name":"Department of Pathology The University of Hong Kong Hong Kong Hong Kong"},{"name":"Pathology Hong Kong Sanatorium and Hospital Hong Kong Hong Kong"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yogesh","family":"Shivakumar","sequence":"additional","affiliation":[{"name":"Department of Genomics Strand Life Sciences Bangalore India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lan","family":"Beppu","sequence":"additional","affiliation":[{"name":"Clinical Research Division Fred Hutchinson Cancer Research Center Seattle WA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Prasanthi","family":"Bhagavatula","sequence":"additional","affiliation":[{"name":"Digital Biology Group Bio\u2010Rad Pleasanton CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Chantry","sequence":"additional","affiliation":[{"name":"Faculty of Medicine Dentistry and Health Department of Oncology and Metabolism University of Sheffield Sheffield UK"},{"name":"Department of Haematology Sheffield Teaching Hospitals NHS Foundation Trust Sheffield UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,6,10]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41375-020-0776-2"},{"key":"e_1_2_6_3_1","unstructured":"European Medicines Agency.Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man Condition Specific Guidance[Internet].2015[cited 2018 May 4]. Available from:http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2016\/02\/WC500201945.pdf."},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2015.66.2866"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/leu.2017.63"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(18)30192-X"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.leu.2404388"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1038\/leu.2009.168"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2008-04-150680"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2010-06-291641"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1038\/leu.2016.90"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjh.14557"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jmoldx.2013.10.007"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V124.21.4540.4540"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/ajh.24120"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jmoldx.2019.08.007"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2020.5774"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2141.2011.08603.x"},{"key":"e_1_2_6_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.beha.2009.04.001"},{"key":"e_1_2_6_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00404-016-4262-z"},{"key":"e_1_2_6_21_1","doi-asserted-by":"publisher","DOI":"10.1038\/bmt.2009.177"},{"key":"e_1_2_6_22_1","doi-asserted-by":"publisher","DOI":"10.1038\/leu.2015.29"},{"key":"e_1_2_6_23_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.analchem.6b03076"},{"key":"e_1_2_6_24_1","doi-asserted-by":"publisher","DOI":"10.1097\/HS9.0000000000000496"}],"container-title":["British Journal of Haematology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bjh.17521","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/bjh.17521","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bjh.17521","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,24]],"date-time":"2023-08-24T05:56:43Z","timestamp":1692856603000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/bjh.17521"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,6,10]]},"references-count":23,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,7]]}},"alternative-id":["10.1111\/bjh.17521"],"URL":"https:\/\/doi.org\/10.1111\/bjh.17521","archive":["Portico"],"relation":{},"ISSN":["0007-1048","1365-2141"],"issn-type":[{"value":"0007-1048","type":"print"},{"value":"1365-2141","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,6,10]]},"assertion":[{"value":"2021-01-06","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-03-21","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-06-10","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}