|
Title
|
|
|
|
Correlation of ROS1 immunohistochemistry with ROS1 fusion status determined by fluorescence in situ hybridization
| |
|
Author
|
|
|
|
| |
|
Abstract
|
|
|
|
| Context.-The ability to determine ROS1 status has become mandatory for patients with lung adenocarcinoma, as many global authorities have approved crizotinib for patients with ROS1-positive lung adenocarcinoma. Objective.-To present analytical correlation of the VENTANA ROS1 (SP384) Rabbit Monoclonal Primary Antibody (ROS1 [SP384] antibody) with ROS1 fluorescence in situ hybridization (FISH). Design.-The immunohistochemistry (IHC) and FISH analytical comparison was assessed by using 122 non-small cell lung cancer samples that had both FISH (46 positive and 76 negative cases) and IHC staining results available. In addition, reverse transcription-polymerase chain reaction (RT-PCR) as well as DNA and RNA next-generation sequencing (NGS) were used to further examine the ROS1 status in cases that were discrepant between FISH and IHC, based on staining in the cytoplasm of 2+ or above in more than 30% of total tumor cells considered as IHC positive. Here, we define the consensus status as the most frequent result across the 5 different methods (IHC, FISH, RT-PCR, RNA NGS, and DNA NGS) we used to determine ROS1 status in these cases. Results.-Of the IHC scoring methods examined, staining in the cytoplasm of 2+ or above in more than 30% of total tumor cells considered as IHC positive had the highest correlation with a FISH-positive status, reaching a positive percentage agreement of 97.8% and negative percentage agreement of 89.5%. A positive percentage agreement (100%) and negative percentage agreement (92.0%) was reached by comparing ROS1 (SP384) using a cutoff for staining in the cytoplasm of 2+ or above in more than 30% of total tumor cells to the consensus status. Conclusions.-Herein, we present a standardized staining protocol for ROS1 (SP384) and data that support the high correlation between ROS1 status and ROS1 (SP384) antibody. |
| |
|
Language
|
|
|
|
English
| |
|
Source (journal)
|
|
|
|
Archives of pathology and laboratory medicine / American Medical Association; College of American Pathologists [Northfield, Ill.] - Chicago, Ill., 1976, currens
| |
|
Publication
|
|
|
|
Chicago, Ill.
:
American Medical Association
,
2020
| |
|
ISSN
|
|
|
|
0003-9985
[print]
1543-2165
[online]
| |
|
DOI
|
|
|
|
10.5858/ARPA.2019-0085-OA
| |
|
Volume/pages
|
|
|
|
144
:6
(2020)
, p. 735-741
| |
|
ISI
|
|
|
|
000536960600011
| |
|
Pubmed ID
|
|
|
|
31509456
| |
|
Full text (Publisher's DOI)
|
|
|
|
| |
|
Full text (open access)
|
|
|
|
| |
|