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ALK Immunohistochemistry in NSCLC: Discordant Staining Can Impact Patient Treatment Regimen.

Ibrahim, Merdol and Parry, Suzanne and Wilkinson, Dawn and Bilbe, Neil and Allen, David and Forrest, Steven and Maxwell, Perry and O'Grady, Anthony and Starczynski, Jane and Tanier, Philippe and Gosney, John and Kerr, Keith and Miller, Keith and Thunnissen, Erik (2016) ALK Immunohistochemistry in NSCLC: Discordant Staining Can Impact Patient Treatment Regimen. Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 11 (12). pp. 2241-2247. ISSN 1556-1380. This article is accessible to all HEFT staff and students via http://tinyurl.com/z795c8c using their Athens login IDs

Full text not available from this repository.
Official URL: http://www.jto.org/article/S1556-0864(16)30630-X/a...

Abstract

INTRODUCTION

Diagnostic immunohistochemistry (IHC) is increasingly accepted as a screening method for anaplastic lymphoma receptor tyrosine kinase gene (ALK) rearrangements in NSCLC. We have sought to establish an ongoing robust external quality assessment process to gauge quality of anaplastic lymphoma kinase (ALK) IHC, which can have an impact on interpretation of patient samples.

METHODS

Unstained tissue and cell line samples were distributed on a quarterly basis to participating laboratories from 30 countries. Participants stained the slide using their routine diagnostic ALK IHC method and returned the slide along with their in-house control and methodology details. Slides were assessed by a team of pathologists and scientists.

RESULTS

Overall, there was a mean pass rate of 83% (range 71%-98%), with 38 variations in staining protocol. Methods included the following: the Roche D5F3 assay (65% of users, pass rate 93%); Novocastra 5A4 (15% of users, pass rate 65%); Cell Signaling Technology D5F3 (7% of users, pass rate 91%), and Dako ALK1 (5% of users, pass rate 50%). Choice of methodology directly affected final interpretation of distributed ALK-positive and ALK-negative NSCLC cases, which were correctly identified by 89% and 88% of participants, respectively. Antibody detection method was a contributing factor in false-negative staining results. The choice of laboratory controls was found to be unsuitable, and as such, in-house control recommendations are also provided.

CONCLUSIONS

ALK IHC is a robust screening technique, but there is concern that some diagnostic laboratories are using inadequate staining methods, which has a direct impact on final interpretation. External assessment helps provide laboratories with continued confidence in their ALK IHC testing.

Item Type: Article
Additional Information: This article is accessible to all HEFT staff and students via http://tinyurl.com/z795c8c using their Athens login IDs
Subjects: QW Microbiology. Immunology
QY Clinical pathology
Divisions: Clinical Support > Pathology
Related URLs:
Depositing User: Mrs Caroline Tranter
Date Deposited: 02 Feb 2017 14:33
Last Modified: 02 Feb 2017 14:33
URI: http://www.repository.heartofengland.nhs.uk/id/eprint/1148

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