Validation of MYC and BCL6 rapid break apart digital fluorescence in situ hybridization assays for clinical use.
GenASIs analysis system
digital pathology
Journal
International journal of clinical and experimental pathology
ISSN: 1936-2625
Titre abrégé: Int J Clin Exp Pathol
Pays: United States
ID NLM: 101480565
Informations de publication
Date de publication:
2023
2023
Historique:
received:
29
11
2022
accepted:
29
03
2023
medline:
12
5
2023
pubmed:
12
5
2023
entrez:
11
5
2023
Statut:
epublish
Résumé
Detection of gene rearrangements in Validation was a four-phase process involving initial development of the assays by testing new probes in a manual protocol, and cytogenetic studies to confirm the probe specificity, sensitivity, and localization. In the next phase, the assays were validated as a manual assay. The third phase involved development of the digital FISH assays by testing and optimizing the GenASIs Scan and Analysis instrument. In the final phase, the digital FISH assays were validated. Cytogenetic studies confirmed 100% probe sensitivity/specificity, and localization patterns. Negative reference range cutoffs calculated from 20 normal lymph nodes using the inverse of the beta cumulative probability density function (Excel BETAINV calculation) were 11% inclusive for both manual and digital MYC and BCL6 assays. There was 100% concordance between the manual and digital methods. The shortened hybridization time decreased the overall workflow time by 14.5 hours. This study validates the use of the SureFISH MYC and BCL6 probes on formalin fixed paraffin embedded (FFPE) tissue sections using a hybridization time of 1.5 hours that shortened the overall workflow by 14.5 hours. The process described also provides a standardized framework for validating digital FISH assays in the future.
Types de publication
Journal Article
Langues
eng
Pagination
76-85Informations de copyright
IJCEP Copyright © 2023.
Déclaration de conflit d'intérêts
None.
Références
Nat Rev Mol Cell Biol. 2020 May;21(5):255-267
pubmed: 32071436
Oncogene. 2003 Jan 30;22(4):507-16
pubmed: 12555064
Nature. 1983 Feb 24;301(5902):722-5
pubmed: 6298632
Rinsho Ketsueki. 2019;60(3):155-164
pubmed: 31068510
Leuk Lymphoma. 1997 Sep;27(1-2):53-63
pubmed: 9373196
Blood Adv. 2018 Oct 23;2(20):2755-2765
pubmed: 30348671
Pathol Res Pract. 2020 Sep;216(9):153040
pubmed: 32825928
Blood. 2000 Aug 1;96(3):808-22
pubmed: 10910891
Leukemia. 2009 Feb;23(2):225-34
pubmed: 18923440
Cancer Treat Rev. 2021 Mar;94:102154
pubmed: 33524794
FASEB J. 1992 Sep;6(12):3065-72
pubmed: 1521738
Nat Rev Clin Oncol. 2022 Jan;19(1):23-36
pubmed: 34508258
Leukemia. 2022 Jul;36(7):1720-1748
pubmed: 35732829
Signal Transduct Target Ther. 2018 Feb 23;3:5
pubmed: 29527331
Am J Surg Pathol. 2008 Jan;32(1):113-22
pubmed: 18162778
PLoS One. 2014 Apr 14;9(4):e95047
pubmed: 24733537
J Hematol Oncol. 2022 Mar 18;15(1):26
pubmed: 35303910
Eur J Haematol. 2014 Jan;92(1):42-8
pubmed: 24118498
Proc Natl Acad Sci U S A. 1982 Dec;79(24):7824-7
pubmed: 6961453
J Pathol Inform. 2016 May 04;7:20
pubmed: 27217970
Cancer Res. 2000 May 1;60(9):2335-41
pubmed: 10811103
J Clin Med. 2020 Nov 18;9(11):
pubmed: 33217963
Blood. 2001 Jun 15;97(12):3713-20
pubmed: 11389007
Virchows Arch. 2023 Jan;482(1):193-205
pubmed: 36057749
Anticancer Res. 2003 Mar-Apr;23(2A):1139-48
pubmed: 12820362
Blood. 2015 Nov 26;126(22):2466-74
pubmed: 26373676
Blood. 2023 Feb 23;141(8):904-916
pubmed: 36201743
Mod Pathol. 2010 Jul;23(7):909-20
pubmed: 20348878
Cell. 2012 Mar 30;149(1):22-35
pubmed: 22464321
Ann Lab Med. 2018 Nov;38(6):619-622
pubmed: 30027711
Hum Pathol. 2021 Jul;113:9-19
pubmed: 33771538
EBioMedicine. 2022 Jan;75:103756
pubmed: 34942444
Genes Chromosomes Cancer. 1995 Sep;14(1):1-7
pubmed: 8527378
Immunol Rev. 2019 Mar;288(1):178-197
pubmed: 30874346
Histopathology. 2017 Jan;70(1):134-145
pubmed: 27960232
Diagn Pathol. 2021 May 11;16(1):42
pubmed: 33975608
Mod Pathol. 2006 Jan;19(1):25-33
pubmed: 16258503