AUTHOR=Hou Chunxiao , Song Xueru , Chen Hongwei , Chang Chengdong , Lu Jinfeng , Li Cheng , Qu Haiyan , Guo Rui , Xu Jingyi , Xu Liming 

TITLE=A novel automated IHC staining system for quality control application in ALK immunohistochemistry testing

JOURNAL=Pathology and Oncology Research

VOLUME=Volume 31 - 2025

YEAR=2025

URL=https://www.por-journal.com/journals/pathology-and-oncology-research/articles/10.3389/pore.2025.1611964

DOI=10.3389/pore.2025.1611964

ISSN=1532-2807

ABSTRACT=Positive and negative controls setting in immunohistochemistry (IHC) screening for anaplastic lymphoma kinase (ALK) rearrangements is essential for treating lung adenocarcinoma. However, positive control of patient tissue is scarce and with ethical issues. A novel automated solution for ALK IHC quality control management was investigated by comparing with the established D5F3 antibody on VENTANA system in 87 lung adenocarcinoma specimens with known ALK status reanalyzed by fluorescence in-situ hybridization. The BP6165 concentrated antibody on the LYNX480 PLUS platform had excellent sensitivity and specificity (98.30% and 100%, respectively) in 87 biopsy specimens. The ALK controls in liquid form (CLF) applied in the automatic way showed more regularly circular shape and better cell distribution than manually. In addition, the novel controls can demonstrate the changes in the same pattern as tissue controls under the different antibody concentration and antigen retrieval conditions. The automated solution for ALK IHC quality control management provides a convenient solution without consumption of scarce tissue for IHC testing in day-to-day pathologic practice. Availability of standardized protocols for ALK rearrangements detection using the BP6165 concentrated antibody on the LYNX480 PLUS platform will expand the number of laboratories and determine eligibility of patients with lung adenocarcinoma for treatment with ALK tyrosine kinase inhibitors in a reliable and concordant manner.