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Open AccessArticle

Improving the Diagnostic Accuracy of the PD-L1 Test with Image Analysis and Multiplex Hybridization

1
Precision Medicine Centre of Excellence, The Patrick G Johnston Centre for Cancer Research, Queen’s University, Belfast BT9 7BL, UK
2
Cellular Pathology, Belfast Health and Social Care Trust, Belfast City Hospital, Lisburn Road, Belfast BT9 7BL, UK
3
Northern Ireland Biobank, The Patrick G Johnston Centre for Cancer Research, Queen’s University, Belfast BT9 7BL, UK
*
Author to whom correspondence should be addressed.
Cancers 2020, 12(5), 1114; https://doi.org/10.3390/cancers12051114
Received: 18 March 2020 / Revised: 21 April 2020 / Accepted: 26 April 2020 / Published: 29 April 2020
(This article belongs to the Special Issue Surgical Pathology in the Digital Era)
Targeting of the programmed cell death protein (PD-1)/programmed death-ligand 1 (PD-L1) axis with checkpoint inhibitors has changed clinical practice in non-small cell lung cancer (NSCLC). However, clinical assessment remains complex and ambiguous. We aim to assess whether digital image analysis (DIA) and multiplex immunofluorescence can improve the accuracy of PD-L1 diagnostic testing. A clinical cohort of routine NSCLC patients reflex tested for PD-L1 (SP263) immunohistochemistry (IHC), was assessed using DIA. Samples of varying assessment difficulty were assessed by multiplex immunofluorescence. Sensitivity, specificity, and concordance was evaluated between manual diagnostic evaluation and DIA for chromogenic and multiplex IHC. PD-L1 expression by DIA showed significant concordance (R² = 0.8248) to manual assessment. Sensitivity and specificity was 86.8% and 91.4%, respectively. Evaluation of DIA scores revealed 96.8% concordance to manual assessment. Multiplexing enabled PD-L1+/CD68+ macrophages to be readily identified within PD-L1+/cytokeratin+ or PD-L1-/cytokeratin+ tumor nests. Assessment of multiplex vs. chromogenic IHC had a sensitivity and specificity of 97.8% and 91.8%, respectively. Deployment of DIA for PD-L1 diagnostic assessment is an accurate process of case triage. Multiplex immunofluorescence provided higher confidence in PD-L1 assessment and could be offered for challenging cases by centers with appropriate expertise and specialist equipment. View Full-Text
Keywords: PD-L1; clinical workflow; multiplexing; image analysis PD-L1; clinical workflow; multiplexing; image analysis
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Humphries, M.P.; Bingham, V.; Abdullahi Sidi, F.; Craig, S.G.; McQuaid, S.; James, J.; Salto-Tellez, M. Improving the Diagnostic Accuracy of the PD-L1 Test with Image Analysis and Multiplex Hybridization. Cancers 2020, 12, 1114.

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