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  • Malapelle, UmbertoUniversity of Naples Federico II (author)

Reference standards for gene fusion molecular assays on cytological samples : an international validation study

  • Article/chapterEnglish2023

Publisher, publication year, extent ...

  • 2021-08-24
  • BMJ,2023
  • 6 s.

Numbers

  • LIBRIS-ID:oai:lup.lub.lu.se:ee5f0b95-b933-4553-bc6e-0b8dbff1644c
  • https://lup.lub.lu.se/record/ee5f0b95-b933-4553-bc6e-0b8dbff1644cURI
  • https://doi.org/10.1136/jclinpath-2021-207825DOI

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  • Language:English
  • Summary in:English

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  • Subject category:art swepub-publicationtype
  • Subject category:ref swepub-contenttype

Notes

  • Aims Gene fusions assays are key for personalised treatments of advanced human cancers. Their implementation on cytological material requires a preliminary validation that may make use of cell line slides mimicking cytological samples. In this international multi-institutional study, gene fusion reference standards were developed and validated. Methods Cell lines harbouring EML4(13)–ALK(20) and SLC34A2(4)–ROS1(32) gene fusions were adopted to prepare reference standards. Eight laboratories (five adopting amplicon-based and three hybridisation-based platforms) received, at different dilution points two sets of slides (slide A 50.0%, slide B 25.0%, slide C 12.5% and slide D wild type) stained by Papanicolaou (Pap) and May Grunwald Giemsa (MGG). Analysis was carried out on a total of 64 slides. Results Four (50.0%) out of eight laboratories reported results on all slides and dilution points. While 12 (37.5%) out of 32 MGG slides were inadequate, 27 (84.4%) out of 32 Pap slides produced libraries adequate for variant calling. The laboratories using hybridisation-based platforms showed the highest rate of inadequate results (13/24 slides, 54.2%). Conversely, only 10.0% (4/40 slides) of inadequate results were reported by laboratories adopting amplicon-based platforms. Conclusions Reference standards in cytological format yield better results when Pap staining and processed by amplicon-based assays. Further investigation is required to optimise these standards for MGG stained cells and for hybridisation-based approaches.

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  • Pepe, FrancescoUniversity of Naples Federico II (author)
  • Pisapia, PasqualeUniversity of Naples Federico II (author)
  • Altimari, AnnalisaSt. Orsola-Malpighi University Hospital (author)
  • Bellevicine, ClaudioUniversity of Naples Federico II (author)
  • Brunnström, HansLund University,Lunds universitet,Förbättrad diagnostik och prognostik vid lungcancer och metastaser till lunga,Forskargrupper vid Lunds universitet,LUCC: Lunds universitets cancercentrum,Övriga starka forskningsmiljöer,Patologi, Lund,Sektion V,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Improved diagnostics and prognostics of lung cancer and metastases to the lungs,Lund University Research Groups,LUCC: Lund University Cancer Centre,Other Strong Research Environments,Pathology, Lund,Section V,Department of Clinical Sciences, Lund,Faculty of Medicine(Swepub:lu)med-hsb (author)
  • Bruno, RossellaUniversity of Pisa (author)
  • Büttner, ReinhardUniversity of Cologne (author)
  • Cirnes, LuisUniversity of Porto (author)
  • De Andrea, Carlos E.University of Navarra (author)
  • de Biase, DarioUniversity of Bologna (author)
  • Dumur, Catherine I.Aurora Diagnostics (author)
  • Lindquist, Kajsa EricsonLund University,Lunds universitet,Patologi, Lund,Sektion V,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Pathology, Lund,Section V,Department of Clinical Sciences, Lund,Faculty of Medicine(Swepub:lu)onk-ker (author)
  • Fontanini, GabriellaUniversity of Pisa (author)
  • Gautiero, EugenioUniversity of Milano-Bicocca (author)
  • Gentien, DavidCurie Institute, Paris (author)
  • Hofman, PaulCHU Hôpital Pasteur 2, Nice (author)
  • Hofman, VeroniqueCHU Hôpital Pasteur 2, Nice (author)
  • Iaccarino, AntoninoUniversity of Naples Federico II (author)
  • Lozano, Maria DoloresUniversity of Navarra (author)
  • Mayo-De-Las-Casas, ClaraUniversity Hospital Dexeus (author)
  • Merkelbach-Bruse, SabineUniversity of Cologne (author)
  • Pagni, FabioUniversity of Milano-Bicocca (author)
  • Roman, RuthUniversity Hospital Dexeus (author)
  • Schmitt, Fernando C.University of Porto (author)
  • Siemanowski, JannaUniversity of Cologne (author)
  • Roy-Chowdhuri, SinchitaUniversity of Texas (author)
  • Tallini, GiovanniUniversity of Bologna (author)
  • Tresserra, FrancescUniversity Hospital Dexeus (author)
  • Borght, Sara VanderCatholic University of Leuven (author)
  • Vielh, PhilippeThe American Hospital of Paris (author)
  • Vigliar, ElenaUniversity of Naples Federico II (author)
  • Vita, Giulia Anna CarmenIRCCS-CROB, Referral Cancer Center of Basilicata (author)
  • Weynand, BirgitCatholic University of Leuven (author)
  • Rosell, RafaelHospital Municipal de Badalona (author)
  • Vila, Miguel Angel MolinaUniversity Hospital Dexeus (author)
  • Troncone, GiancarloUniversity of Naples Federico II (author)
  • University of Naples Federico IISt. Orsola-Malpighi University Hospital (creator_code:org_t)

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  • In:Journal of Clinical Pathology: BMJ76:1, s. 47-520021-97461472-4146

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