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

Area of Science:

• Oncology
• Pathology
• Biotechnology

Background:

• Accurate anaplastic lymphoma kinase (ALK) testing is crucial for lung adenocarcinoma treatment.
• Established immunohistochemistry (IHC) methods require reliable positive and negative controls.
• Patient tissue controls for ALK IHC present ethical challenges and scarcity issues.

Purpose of the Study:

• To evaluate a novel automated solution for ALK IHC quality control management.
• To assess the performance of a new concentrated antibody (BP6165) on the LYNX480 PLUS platform.
• To compare automated liquid controls with traditional tissue controls.

Main Methods:

• Investigated a novel automated ALK IHC quality control system using BP6165 concentrated antibody on the LYNX480 PLUS platform.
• Compared the automated system with the established D5F3 antibody on the VENTANA system.
• Analyzed 87 lung adenocarcinoma specimens with known ALK status, re-verified by fluorescence in situ hybridization.

Main Results:

• The BP6165 antibody demonstrated high sensitivity (98.30%) and specificity (100%) in 87 biopsy specimens.
• Automated liquid controls (CLFs) showed improved morphology and cell distribution compared to manual application.
• Novel controls mimicked tissue control responses to varying antibody concentrations and antigen retrieval conditions.

Conclusions:

• The automated ALK IHC quality control solution provides a convenient and ethical alternative to scarce patient tissue.
• Standardized protocols with BP6165 antibody on the LYNX480 PLUS platform enhance reliable ALK testing for lung adenocarcinoma patients.
• This advancement facilitates wider laboratory adoption for determining eligibility for ALK tyrosine kinase inhibitor therapy.