Diagnostic Accuracy in Fit-for-Purpose PD-L1 Testing

Applied Immunohistochemistry & Molecular Morphology : AIMM
Carol C CheungEmina E Torlakovic

Abstract

PD-L1 testing by immunohistochemistry (IHC) has presented significant challenges not only for clinical laboratories, but also for external quality assurance (EQA) entities that provide proficiency testing (PT) for clinical laboratories. Canadian Immunohistochemistry Quality Control (CIQC) has used educational runs to explore approaches to sample design and analysis of results that would enhance patient safety. As PT for predictive biomarkers requires modeling at every level (design of the run, assessment of the run, and reporting of "pass" or "fail") based on "fit-for-purpose" principles, CIQC has applied those principles to PD-L1 PT runs. Each laboratory received unstained slides with TMA tissue cores from 104 randomly selected primary NSCLC and tonsil tissues to test with their current PD-L1 assay. Diagnostic sensitivity and specificity were calculated against designated gold standards based on the "3D" approach (drug-disease-diagnostic assay). Depending on the selection of fit-for-purpose gold standards and also on the selection of what was considered fit-for-purpose cut-off points, great variation in the performance (accuracy) of both companion/complementary diagnostic assays and laboratory developed tests was seen. "Fit-fo...Continue Reading

References

Dec 5, 2014·Applied Immunohistochemistry & Molecular Morphology : AIMM·Emina E TorlakovicMogens Vyberg
Jul 9, 2016·Modern Pathology : an Official Journal of the United States and Canadian Academy of Pathology, Inc·Andreas H ScheelReinhard Buettner
Dec 7, 2016·Applied Immunohistochemistry & Molecular Morphology : AIMM·Carol C CheungUNKNOWN From the International Society for Immunohistochemistry and Molecular Morphology (ISIMM) and International Quality Network f
Aug 19, 2017·Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer·Antonio MarchettiMauro Papotti
Jan 20, 2018·Annals of Oncology : Official Journal of the European Society for Medical Oncology·J AdamS Lantuéjoul

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Citations

Feb 6, 2019·Applied Immunohistochemistry & Molecular Morphology : AIMM·Paul E Swanson
Oct 5, 2019·Applied Immunohistochemistry & Molecular Morphology : AIMM·Carol C CheungUNKNOWN Canadian Association of Pathologists-Association Canadienne Des Pathologistes’ National Standards Committee for High Complex
Apr 14, 2020·Applied Immunohistochemistry & Molecular Morphology : AIMM·Emina E Torlakovic

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Methods Mentioned

BETA
Assay

Software Mentioned

TMA Scorer
RefLabRefKit
CIQC

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