{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T15:27:55Z","timestamp":1788190075594,"version":"build-2803163510"},"reference-count":16,"publisher":"Walter de Gruyter GmbH","issue":"12","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,11,26]]},"abstract":"Abstract<\/jats:title>\n \n Objectives<\/jats:title>\n The quantitation of BCR-ABL1<\/jats:italic> mRNA is mandatory for chronic myeloid leukemia (CML) patients, and RT-qPCR is the most extensively used method in testing laboratories worldwide. Nevertheless, substantial variation in RT-qPCR results makes inter-laboratory comparability hard. To facilitate inter-laboratory comparative assessment, an international scale (IS) for BCR-ABL1<\/jats:italic> was proposed.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n The laboratory-specific conversion factor (CF) to the IS can be derived from the World Health Organization (WHO) genetic reference panel; however, this material is limited to the manufacturers to produce and calibrate secondary reference reagents. Therefore, we developed secondary reference calibrators, as lyophilized cellular material, aligned to the IS. Our purpose was both to re-evaluate the CF in 18 previously harmonized laboratories and to propagate the IS to new laboratories.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n Our field trial including 30 laboratories across Latin America showed that, after correction of raw BCR-ABL1\/ABL1<\/jats:italic> ratios using CF, the relative mean bias was significantly reduced. We also performed a follow-up of participating laboratories by annually revalidating the process; our results support the need for continuous revalidation of CFs. All participating laboratories also received a calibrator to determine the limit of quantification (LOQ); 90% of them could reproducibly detect BCR-ABL1<\/jats:italic>, indicating that these laboratories can report a consistent deep molecular response. In addition, aiming to investigate the variability of BCR-ABL1<\/jats:italic> measurements across different RNA inputs, we calculated PCR efficiency for each individual assay by using different amounts of RNA.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n In conclusion, for the first time in Latin America, we have successfully organized a harmonization platform for BCR-ABL1<\/jats:italic> measurement that could be of immediate clinical benefit for monitoring the molecular response of patients in low-resource regions.<\/jats:p>\n <\/jats:sec>","DOI":"10.1515\/cclm-2019-1283","type":"journal-article","created":{"date-parts":[[2020,5,26]],"date-time":"2020-05-26T17:10:13Z","timestamp":1590513013000},"page":"2025-2035","source":"Crossref","is-referenced-by-count":12,"title":["Programme for Harmonization to the International Scale in Latin America for BCR-ABL1<\/i> quantification in CML patients: findings and recommendations"],"prefix":"10.1515","volume":"58","author":[{"given":"Mar\u00eda Sol","family":"Ruiz","sequence":"first","affiliation":[{"name":"CIO-FUCA , Centro de Investigaciones Oncol\u00f3gicas \u2013 Fundaci\u00f3n C\u00e1ncer, Ciudad Aut\u00f3noma de Buenos Aires , Buenos Aires , Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar\u00eda Bel\u00e9n","family":"S\u00e1nchez","sequence":"additional","affiliation":[{"name":"CIO-FUCA , Centro de Investigaciones Oncol\u00f3gicas \u2013 Fundaci\u00f3n C\u00e1ncer, Ciudad Aut\u00f3noma de Buenos Aires , Buenos Aires , Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuly Masiel","family":"Vera Contreras","sequence":"additional","affiliation":[{"name":"CIO-FUCA , Centro de Investigaciones Oncol\u00f3gicas \u2013 Fundaci\u00f3n C\u00e1ncer, Ciudad Aut\u00f3noma de Buenos Aires , Buenos Aires , Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evangelina","family":"Agrielo","sequence":"additional","affiliation":[{"name":"LEB, Laboratorio de Especialidades Bioqu\u00edmicas, Bahia Blanca , Buenos Aires , Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marta","family":"Alonso","sequence":"additional","affiliation":[{"name":"Hospital Nac. A. Posadas, El Palomar , Buenos Aires , Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar\u00eda Eugenia","family":"Altuna","sequence":"additional","affiliation":[{"name":"Clinica Dr. Roberto Ra\u00f1a , Neuquen , Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar\u00eda Sol","family":"Anchordoqui","sequence":"additional","affiliation":[{"name":"Argenomics, Pilar , Buenos Aires , Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariana","family":"Asinari","sequence":"additional","affiliation":[{"name":"Hospital Privado Universitario , Cordoba , Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar\u00eda Elisa","family":"Bonetto","sequence":"additional","affiliation":[{"name":"Hospital Dr. G. Rawson , San Juan , Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mauricio","family":"Camargo","sequence":"additional","affiliation":[{"name":"Gen\u00e9tica Lab, Medell\u00edn , Antioquia , Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabel","family":"Giere","sequence":"additional","affiliation":[{"name":"Fundaleu, Ciudad Aut\u00f3noma de Buenos Aires , Buenos Aires , Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier","family":"Gonz\u00e1lez","sequence":"additional","affiliation":[{"name":"Meyer Lab , Asunci\u00f3n , Paraguay"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana Cecilia","family":"Granda Alacote","sequence":"additional","affiliation":[{"name":"Laboratorios Medicos A Yuen y G Rios , Lima , Peru"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier","family":"Guerra","sequence":"additional","affiliation":[{"name":"Nanopharmacia Diagnostica , Ciudad de Mexico , Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marina","family":"Guti\u00e9rrez","sequence":"additional","affiliation":[{"name":"Stamboulian, Ciudad Aut\u00f3noma de Buenos Aires , Buenos Aires , Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cecilia","family":"Maldonado","sequence":"additional","affiliation":[{"name":"ManLab, Ciudad Aut\u00f3noma de Buenos Aires , Buenos Aires , Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ricardo","family":"Makiya","sequence":"additional","affiliation":[{"name":"FIBIO, Ciudad Aut\u00f3noma de Buenos Aires , Buenos Aires , Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gonzalo","family":"Manrique","sequence":"additional","affiliation":[{"name":"ASESP, Asociaci\u00f3n Espa\u00f1ola , Montevideo , Uruguay"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar\u00eda Eugenia","family":"Monaco","sequence":"additional","affiliation":[{"name":"Laboratorio Tucuman, San Miguel de Tucum\u00e1n , Tucum\u00e1n , Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan Carlos","family":"Rozo","sequence":"additional","affiliation":[{"name":"UDHO, Unidad de Diagn\u00f3stico Hemato Oncol\u00f3gico, Cali , Valle del Cauca , Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlos","family":"Santamar\u00eda","sequence":"additional","affiliation":[{"name":"Hospital de Ni\u00f1os Carlos S\u00e1enz Herrera , San Jos\u00e9 , Costa Rica"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anal\u00eda","family":"Seravalle","sequence":"additional","affiliation":[{"name":"CIBIC , Rosario, Santa Fe , Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olga","family":"Zea","sequence":"additional","affiliation":[{"name":"Gen\u00e9tica Lab, Medell\u00edn , Antioquia , Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar\u00eda Noel","family":"Zubillaga","sequence":"additional","affiliation":[{"name":"ASESP, Asociaci\u00f3n Espa\u00f1ola , Montevideo , Uruguay"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9","family":"Mordoh","sequence":"additional","affiliation":[{"name":"CIO-FUCA , Centro de Investigaciones Oncol\u00f3gicas \u2013 Fundaci\u00f3n C\u00e1ncer, Ciudad Aut\u00f3noma de Buenos Aires , Buenos Aires , Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irene","family":"Larripa","sequence":"additional","affiliation":[{"name":"IMEX, Instituto de Medicina Experimental, CONICET \u2013 Academia Nacional de Medicina, Ciudad Aut\u00f3noma de Buenos Aires , Buenos Aires , Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michele","family":"Bianchini","sequence":"additional","affiliation":[{"name":"CIO-FUCA , Centro de Investigaciones Oncol\u00f3gicas \u2013 Fundaci\u00f3n C\u00e1ncer, Ciudad Aut\u00f3noma de Buenos Aires , Buenos Aires , Argentina"},{"name":"Argenomics, Pilar , Buenos Aires , Argentina"},{"name":"IMEX, Instituto de Medicina Experimental, CONICET \u2013 Academia Nacional de Medicina, Ciudad Aut\u00f3noma de Buenos Aires , Buenos Aires , Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2020,5,5]]},"reference":[{"key":"2023033111431190362_j_cclm-2019-1283_ref_001","doi-asserted-by":"crossref","unstructured":"Branford S, Cross NC, Hochhaus A, Radich J, Saglio G, Kaeda J, et al. 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