Programme for Harmonization to the International Scale in Latin America for BCR-ABL1 quantification in CML patients: Findings and recommendations
- Autores
- Ruiz, María Sol; Sánchez, María Belén; Vera Contreras, Yuly Masiel; Agrielo, Evangelina; Alonso, Marta; Altuna, María Eugenia; Anchordoqui, María Sol; Asinari, Mariana; Bonetto, María Elisa; Camargo, Mauricio; Giere, Isabel; González, Javier; Granda Alacote, Ana Cecilia; Guerra, Javier; Gutiérrez, Marina; Maldonado, Cecilia; Makiya, Ricard; Manrique, Gonzalo; Monaco, María Eugenia; Rozo, Juan Carlos; Santamaría Martín, Carlos Jose; Seravalle, Analía; Zea, Olga; Zubillaga, María Noel; Mordoh, José; Larripa, Irene Beatriz; Bianchini, Michele
- Año de publicación
- 2020
- Idioma
- inglés
- Tipo de recurso
- artículo
- Estado
- versión publicada
- Descripción
- The quantitation of BCR-ABL1 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 was proposed.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.Results Our field trial including 30 laboratories across Latin America showed that, after correction of raw BCR-ABL1/ABL1 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, indicating that these laboratories can report a consistent deep molecular response. In addition, aiming to investigate the variability of BCR-ABL1 measurements across different RNA inputs, we calculated PCR efficiency for each individual assay by using different amounts of RNA.Conclusions In conclusion, for the first time in Latin America, we have successfully organized a harmonization platform for BCR-ABL1 measurement that could be of immediate clinical benefit for monitoring the molecular response of patients in low-resource regions.
Fil: Ruiz, María Sol. Fundación Cáncer. Centro de Investigaciones Oncológicas; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Sánchez, María Belén. Fundación Cáncer. Centro de Investigaciones Oncológicas; Argentina
Fil: Vera Contreras, Yuly Masiel. Fundación Cáncer. Centro de Investigaciones Oncológicas; Argentina
Fil: Agrielo, Evangelina. Laboratorio Especialidades Bioquímicas; Argentina
Fil: Alonso, Marta. Hospital Nacional Profesor Alejandro Posadas; Argentina
Fil: Altuna, María Eugenia. Clinica Roberto Raña; Argentina
Fil: Anchordoqui, María Sol. Argenomics; Argentina
Fil: Asinari, Mariana. Hospital Privado Centro Médico de Córdoba; Argentina
Fil: Bonetto, María Elisa. Hospital Rawson San Juan; Argentina
Fil: Camargo, Mauricio. Laboratorio Medellin; Colombia
Fil: Giere, Isabel. Fundación Para Combatir la Leucemia; Argentina
Fil: González, Javier. Meyer Lab; Paraguay
Fil: Granda Alacote, Ana Cecilia. Laboratorios Medicos Lima; Perú
Fil: Guerra, Javier. Nanopharmacia Diagnóstica Mexico; México
Fil: Gutiérrez, Marina. Stamboulian; Argentina
Fil: Maldonado, Cecilia. Manlab; Argentina
Fil: Makiya, Ricard. No especifíca;
Fil: Manrique, Gonzalo. Asociacion Española de Montevideo; Uruguay
Fil: Monaco, María Eugenia. Laboratorio Tucuman; Argentina
Fil: Rozo, Juan Carlos. Unidad de Diagnóstico Hemato Oncológico; Colombia
Fil: Santamaría Martín, Carlos Jose. Hospital de Niños San Jose de Costa Rica; Costa Rica. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Seravalle, Analía. Civic Rosario; Argentina
Fil: Zea, Olga. Laboratorio Medellin Colombia; Colombia
Fil: Zubillaga, María Noel. Asociación Española de Socorros Mutuos; Uruguay
Fil: Mordoh, José. Fundación Cáncer. Centro de Investigaciones Oncológicas; Argentina
Fil: Larripa, Irene Beatriz. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Medicina Experimental. Academia Nacional de Medicina de Buenos Aires. Instituto de Medicina Experimental; Argentina
Fil: Bianchini, Michele. Fundación Cáncer. Centro de Investigaciones Oncológicas; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina - Materia
-
LMC
BCR-ABL1
Harmonization
International Scale
RT-QPCR
PH-IS - Nivel de accesibilidad
- acceso abierto
- Condiciones de uso
- https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
- Repositorio
.jpg)
- Institución
- Consejo Nacional de Investigaciones Científicas y Técnicas
- OAI Identificador
- oai:ri.conicet.gov.ar:11336/146466
Ver los metadatos del registro completo
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Programme for Harmonization to the International Scale in Latin America for BCR-ABL1 quantification in CML patients: Findings and recommendationsRuiz, María SolSánchez, María BelénVera Contreras, Yuly MasielAgrielo, EvangelinaAlonso, MartaAltuna, María EugeniaAnchordoqui, María SolAsinari, MarianaBonetto, María ElisaCamargo, MauricioGiere, IsabelGonzález, JavierGranda Alacote, Ana CeciliaGuerra, JavierGutiérrez, MarinaMaldonado, CeciliaMakiya, RicardManrique, GonzaloMonaco, María EugeniaRozo, Juan CarlosSantamaría Martín, Carlos JoseSeravalle, AnalíaZea, OlgaZubillaga, María NoelMordoh, JoséLarripa, Irene BeatrizBianchini, MicheleLMCBCR-ABL1HarmonizationInternational ScaleRT-QPCRPH-IShttps://purl.org/becyt/ford/3.2https://purl.org/becyt/ford/3The quantitation of BCR-ABL1 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 was proposed.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.Results Our field trial including 30 laboratories across Latin America showed that, after correction of raw BCR-ABL1/ABL1 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, indicating that these laboratories can report a consistent deep molecular response. In addition, aiming to investigate the variability of BCR-ABL1 measurements across different RNA inputs, we calculated PCR efficiency for each individual assay by using different amounts of RNA.Conclusions In conclusion, for the first time in Latin America, we have successfully organized a harmonization platform for BCR-ABL1 measurement that could be of immediate clinical benefit for monitoring the molecular response of patients in low-resource regions.Fil: Ruiz, María Sol. Fundación Cáncer. Centro de Investigaciones Oncológicas; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Sánchez, María Belén. Fundación Cáncer. Centro de Investigaciones Oncológicas; ArgentinaFil: Vera Contreras, Yuly Masiel. Fundación Cáncer. Centro de Investigaciones Oncológicas; ArgentinaFil: Agrielo, Evangelina. Laboratorio Especialidades Bioquímicas; ArgentinaFil: Alonso, Marta. Hospital Nacional Profesor Alejandro Posadas; ArgentinaFil: Altuna, María Eugenia. Clinica Roberto Raña; ArgentinaFil: Anchordoqui, María Sol. Argenomics; ArgentinaFil: Asinari, Mariana. Hospital Privado Centro Médico de Córdoba; ArgentinaFil: Bonetto, María Elisa. Hospital Rawson San Juan; ArgentinaFil: Camargo, Mauricio. Laboratorio Medellin; ColombiaFil: Giere, Isabel. Fundación Para Combatir la Leucemia; ArgentinaFil: González, Javier. Meyer Lab; ParaguayFil: Granda Alacote, Ana Cecilia. Laboratorios Medicos Lima; PerúFil: Guerra, Javier. Nanopharmacia Diagnóstica Mexico; MéxicoFil: Gutiérrez, Marina. Stamboulian; ArgentinaFil: Maldonado, Cecilia. Manlab; ArgentinaFil: Makiya, Ricard. No especifíca;Fil: Manrique, Gonzalo. Asociacion Española de Montevideo; UruguayFil: Monaco, María Eugenia. Laboratorio Tucuman; ArgentinaFil: Rozo, Juan Carlos. Unidad de Diagnóstico Hemato Oncológico; ColombiaFil: Santamaría Martín, Carlos Jose. Hospital de Niños San Jose de Costa Rica; Costa Rica. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Seravalle, Analía. Civic Rosario; ArgentinaFil: Zea, Olga. Laboratorio Medellin Colombia; ColombiaFil: Zubillaga, María Noel. Asociación Española de Socorros Mutuos; UruguayFil: Mordoh, José. Fundación Cáncer. Centro de Investigaciones Oncológicas; ArgentinaFil: Larripa, Irene Beatriz. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Medicina Experimental. Academia Nacional de Medicina de Buenos Aires. Instituto de Medicina Experimental; ArgentinaFil: Bianchini, Michele. Fundación Cáncer. Centro de Investigaciones Oncológicas; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaDe Gruyter2020-05-11info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/146466Ruiz, María Sol; Sánchez, María Belén; Vera Contreras, Yuly Masiel; Agrielo, Evangelina; Alonso, Marta; et al.; Programme for Harmonization to the International Scale in Latin America for BCR-ABL1 quantification in CML patients: Findings and recommendations; De Gruyter; Clinical Chemistry and Laboratory Medicine; 58; 12; 11-5-2020; 2025-20351434-6621CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://www.degruyter.com/view/journals/cclm/ahead-of-print/article-10.1515-cclm-2019-1283/article-10.1515-cclm-2019-1283.xmlinfo:eu-repo/semantics/altIdentifier/doi/10.1515/cclm-2019-1283info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-03T10:06:47Zoai:ri.conicet.gov.ar:11336/146466instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-03 10:06:47.692CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse |
| dc.title.none.fl_str_mv |
Programme for Harmonization to the International Scale in Latin America for BCR-ABL1 quantification in CML patients: Findings and recommendations |
| title |
Programme for Harmonization to the International Scale in Latin America for BCR-ABL1 quantification in CML patients: Findings and recommendations |
| spellingShingle |
Programme for Harmonization to the International Scale in Latin America for BCR-ABL1 quantification in CML patients: Findings and recommendations Ruiz, María Sol LMC BCR-ABL1 Harmonization International Scale RT-QPCR PH-IS |
| title_short |
Programme for Harmonization to the International Scale in Latin America for BCR-ABL1 quantification in CML patients: Findings and recommendations |
| title_full |
Programme for Harmonization to the International Scale in Latin America for BCR-ABL1 quantification in CML patients: Findings and recommendations |
| title_fullStr |
Programme for Harmonization to the International Scale in Latin America for BCR-ABL1 quantification in CML patients: Findings and recommendations |
| title_full_unstemmed |
Programme for Harmonization to the International Scale in Latin America for BCR-ABL1 quantification in CML patients: Findings and recommendations |
| title_sort |
Programme for Harmonization to the International Scale in Latin America for BCR-ABL1 quantification in CML patients: Findings and recommendations |
| dc.creator.none.fl_str_mv |
Ruiz, María Sol Sánchez, María Belén Vera Contreras, Yuly Masiel Agrielo, Evangelina Alonso, Marta Altuna, María Eugenia Anchordoqui, María Sol Asinari, Mariana Bonetto, María Elisa Camargo, Mauricio Giere, Isabel González, Javier Granda Alacote, Ana Cecilia Guerra, Javier Gutiérrez, Marina Maldonado, Cecilia Makiya, Ricard Manrique, Gonzalo Monaco, María Eugenia Rozo, Juan Carlos Santamaría Martín, Carlos Jose Seravalle, Analía Zea, Olga Zubillaga, María Noel Mordoh, José Larripa, Irene Beatriz Bianchini, Michele |
| author |
Ruiz, María Sol |
| author_facet |
Ruiz, María Sol Sánchez, María Belén Vera Contreras, Yuly Masiel Agrielo, Evangelina Alonso, Marta Altuna, María Eugenia Anchordoqui, María Sol Asinari, Mariana Bonetto, María Elisa Camargo, Mauricio Giere, Isabel González, Javier Granda Alacote, Ana Cecilia Guerra, Javier Gutiérrez, Marina Maldonado, Cecilia Makiya, Ricard Manrique, Gonzalo Monaco, María Eugenia Rozo, Juan Carlos Santamaría Martín, Carlos Jose Seravalle, Analía Zea, Olga Zubillaga, María Noel Mordoh, José Larripa, Irene Beatriz Bianchini, Michele |
| author_role |
author |
| author2 |
Sánchez, María Belén Vera Contreras, Yuly Masiel Agrielo, Evangelina Alonso, Marta Altuna, María Eugenia Anchordoqui, María Sol Asinari, Mariana Bonetto, María Elisa Camargo, Mauricio Giere, Isabel González, Javier Granda Alacote, Ana Cecilia Guerra, Javier Gutiérrez, Marina Maldonado, Cecilia Makiya, Ricard Manrique, Gonzalo Monaco, María Eugenia Rozo, Juan Carlos Santamaría Martín, Carlos Jose Seravalle, Analía Zea, Olga Zubillaga, María Noel Mordoh, José Larripa, Irene Beatriz Bianchini, Michele |
| author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author author author |
| dc.subject.none.fl_str_mv |
LMC BCR-ABL1 Harmonization International Scale RT-QPCR PH-IS |
| topic |
LMC BCR-ABL1 Harmonization International Scale RT-QPCR PH-IS |
| purl_subject.fl_str_mv |
https://purl.org/becyt/ford/3.2 https://purl.org/becyt/ford/3 |
| dc.description.none.fl_txt_mv |
The quantitation of BCR-ABL1 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 was proposed.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.Results Our field trial including 30 laboratories across Latin America showed that, after correction of raw BCR-ABL1/ABL1 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, indicating that these laboratories can report a consistent deep molecular response. In addition, aiming to investigate the variability of BCR-ABL1 measurements across different RNA inputs, we calculated PCR efficiency for each individual assay by using different amounts of RNA.Conclusions In conclusion, for the first time in Latin America, we have successfully organized a harmonization platform for BCR-ABL1 measurement that could be of immediate clinical benefit for monitoring the molecular response of patients in low-resource regions. Fil: Ruiz, María Sol. Fundación Cáncer. Centro de Investigaciones Oncológicas; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina Fil: Sánchez, María Belén. Fundación Cáncer. Centro de Investigaciones Oncológicas; Argentina Fil: Vera Contreras, Yuly Masiel. Fundación Cáncer. Centro de Investigaciones Oncológicas; Argentina Fil: Agrielo, Evangelina. Laboratorio Especialidades Bioquímicas; Argentina Fil: Alonso, Marta. Hospital Nacional Profesor Alejandro Posadas; Argentina Fil: Altuna, María Eugenia. Clinica Roberto Raña; Argentina Fil: Anchordoqui, María Sol. Argenomics; Argentina Fil: Asinari, Mariana. Hospital Privado Centro Médico de Córdoba; Argentina Fil: Bonetto, María Elisa. Hospital Rawson San Juan; Argentina Fil: Camargo, Mauricio. Laboratorio Medellin; Colombia Fil: Giere, Isabel. Fundación Para Combatir la Leucemia; Argentina Fil: González, Javier. Meyer Lab; Paraguay Fil: Granda Alacote, Ana Cecilia. Laboratorios Medicos Lima; Perú Fil: Guerra, Javier. Nanopharmacia Diagnóstica Mexico; México Fil: Gutiérrez, Marina. Stamboulian; Argentina Fil: Maldonado, Cecilia. Manlab; Argentina Fil: Makiya, Ricard. No especifíca; Fil: Manrique, Gonzalo. Asociacion Española de Montevideo; Uruguay Fil: Monaco, María Eugenia. Laboratorio Tucuman; Argentina Fil: Rozo, Juan Carlos. Unidad de Diagnóstico Hemato Oncológico; Colombia Fil: Santamaría Martín, Carlos Jose. Hospital de Niños San Jose de Costa Rica; Costa Rica. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina Fil: Seravalle, Analía. Civic Rosario; Argentina Fil: Zea, Olga. Laboratorio Medellin Colombia; Colombia Fil: Zubillaga, María Noel. Asociación Española de Socorros Mutuos; Uruguay Fil: Mordoh, José. Fundación Cáncer. Centro de Investigaciones Oncológicas; Argentina Fil: Larripa, Irene Beatriz. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Medicina Experimental. Academia Nacional de Medicina de Buenos Aires. Instituto de Medicina Experimental; Argentina Fil: Bianchini, Michele. Fundación Cáncer. Centro de Investigaciones Oncológicas; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina |
| description |
The quantitation of BCR-ABL1 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 was proposed.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.Results Our field trial including 30 laboratories across Latin America showed that, after correction of raw BCR-ABL1/ABL1 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, indicating that these laboratories can report a consistent deep molecular response. In addition, aiming to investigate the variability of BCR-ABL1 measurements across different RNA inputs, we calculated PCR efficiency for each individual assay by using different amounts of RNA.Conclusions In conclusion, for the first time in Latin America, we have successfully organized a harmonization platform for BCR-ABL1 measurement that could be of immediate clinical benefit for monitoring the molecular response of patients in low-resource regions. |
| publishDate |
2020 |
| dc.date.none.fl_str_mv |
2020-05-11 |
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info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion http://purl.org/coar/resource_type/c_6501 info:ar-repo/semantics/articulo |
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article |
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publishedVersion |
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http://hdl.handle.net/11336/146466 Ruiz, María Sol; Sánchez, María Belén; Vera Contreras, Yuly Masiel; Agrielo, Evangelina; Alonso, Marta; et al.; Programme for Harmonization to the International Scale in Latin America for BCR-ABL1 quantification in CML patients: Findings and recommendations; De Gruyter; Clinical Chemistry and Laboratory Medicine; 58; 12; 11-5-2020; 2025-2035 1434-6621 CONICET Digital CONICET |
| url |
http://hdl.handle.net/11336/146466 |
| identifier_str_mv |
Ruiz, María Sol; Sánchez, María Belén; Vera Contreras, Yuly Masiel; Agrielo, Evangelina; Alonso, Marta; et al.; Programme for Harmonization to the International Scale in Latin America for BCR-ABL1 quantification in CML patients: Findings and recommendations; De Gruyter; Clinical Chemistry and Laboratory Medicine; 58; 12; 11-5-2020; 2025-2035 1434-6621 CONICET Digital CONICET |
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eng |
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eng |
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info:eu-repo/semantics/altIdentifier/url/https://www.degruyter.com/view/journals/cclm/ahead-of-print/article-10.1515-cclm-2019-1283/article-10.1515-cclm-2019-1283.xml info:eu-repo/semantics/altIdentifier/doi/10.1515/cclm-2019-1283 |
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