Volume 65, Issue 4 pp. 539-548
Original Article

Detection of ALK expression in non-small-cell lung cancer with ALK gene rearrangements – comparison of multiple immunohistochemical methods

Karen Zwaenepoel

Corresponding Author

Karen Zwaenepoel

Department of Pathology, Antwerp University Hospital, Edegem, Belgium

Address for correspondence: K Zwaenepoel, Department of Pathology, Antwerp University Hospital, Wilrijkstraat 10, 2650 Edegem, Belgium. e-mail: [email protected]Search for more papers by this author
Amber Van Dongen

Amber Van Dongen

Department of Pathology, Antwerp University Hospital, Edegem, Belgium

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Suzan Lambin

Suzan Lambin

Department of Pathology, Antwerp University Hospital, Edegem, Belgium

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Christine Weyn

Christine Weyn

Department of Pathology, Antwerp University Hospital, Edegem, Belgium

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Patrick Pauwels

Patrick Pauwels

Department of Pathology, Antwerp University Hospital, Edegem, Belgium

Center for Oncological Research (CORE), University of Antwerp, Edegem, Belgium

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First published: 12 March 2014
Citations: 27

Abstract

Aim

Testing for ALK rearrangements in advanced, non-squamous non-small-cell lung cancers that are wild-type for activating EGFR mutation has become standard care. Fluorescence in-situ hybridization is considered the gold standard for this evaluation. Pre-screening with immunohistochemistry has been suggested, to reduce testing costs and to make testing more widely available. By analysing the sensitivity and specificity of different ALK immunohistochemical assays, we aimed to identify the most reliable assay to detect ALK rearrangement.

Methods and results

ALK screening performed by FISH analysis was compared with three different immunohistochemical assays, in which two ALK antibody clones (5A4 and D5F3) were used on two detection platforms (Dako AutostainerLink 48 and Ventana Benchmark GX). Data from 30 ALK FISH-positive cases show that the sensitivity of the immunohistochemical assays varies from 93.3% to 96.6%. Head-to-head comparison of the 5A4 and D5F3 ALK antibody clones demonstrates similar staining potency. In general, homogeneous, intermediate to strong staining of the ALK-positive samples was obtained.

Conclusions

ALK immunohistochemistry can be considered as a pre-screen method if one accepts a sensitivity of 93.3–96.6%. Because ALK immunohistochemical staining needs to be performed close to the detection limit of the assay, vigilant quality control monitoring is required to guarantee trustworthy results.

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