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dc.contributor.authorDodson, Andrew
dc.contributor.authorParry, Suzanne
dc.contributor.authorLissenberg-Witte, Birgit
dc.contributor.authorHaragan, Alex
dc.contributor.authorAllen, David
dc.contributor.authorO'Grady, Anthony
dc.contributor.authorMcClean, Emma
dc.contributor.authorHughes, Jamie
dc.contributor.authorMiller, Keith
dc.contributor.authorThunnissen, Erik
dc.date.accessioned2021-08-16T15:01:34Z
dc.date.available2021-08-16T15:01:34Z
dc.date.issued2019-12-17
dc.identifier.pmid31849189
dc.identifier.doi10.1002/cjp2.153
dc.identifier.urihttp://hdl.handle.net/10147/630085
dc.description.abstractPD-L1 inhibitors are part of first line treatment options for patients with advanced non-small cell lung cancer. PD-L1 immunohistochemistry (IHC) assays act as either a companion or a complementary diagnostic. The purpose of this study is to describe the experience of external quality assurance (EQA) provider UK NEQAS ICC and ISH with the comparison of different PD-L1 assays used in daily practice. Three EQA rounds (pilot, run A and run B) were carried out using formalin fixed paraffin embedded samples with sample sets covering a range of epitope concentrations, including 'critical samples' near to clinical threshold cut-offs. An expert panel (n = 4) evaluated all returned slides simultaneously and independently on a multi-header microscope together with the participants own in-house control material. The tonsil sample was evaluated as 'acceptable' or 'unacceptable', and for the other samples the percentage of PD-L1 stained tumour cells were estimated in predetermined categories (<1%, 1 to <5%, 5 to <10%, 10 to <25%, 25 to <50%, 50 to <80%, 80 to 100%). In the pilot and the two subsequent runs the number of participating laboratories was 43, 69 and 76, respectively. The pass rate for the pilot run was 67%; this increased to 81% at run A and 82% at run B. For two 'critical samples', in runs A and B, 22C3 IHC had significantly higher PD-L1 expression than SP263 IHC (p < 0.001), whilst the PD-L1 scores for the other six samples were similar for all assays. In run A the laboratory developed tests (LDTs) using 22C3 scored lower than the commercial 22C3 tests (p = 0.01). After the initial testing, improvement in performance of PD-L1 IHC is shown for approved and LDT PD-L1 assays. Equivalency of approved PD-L1 22C3 and SP263 assays cannot be assumed as the scores cross the clinically relevant thresholds of 1% and 50% PD-L1 expression.en_US
dc.languageen
dc.language.isoenen_US
dc.rights© 2019 The Authors. The Journal of Pathology: Clinical Research published by The Pathological Society of Great Britain and Ireland and John Wiley & Sons Ltd.
dc.subjectPD-L1en_US
dc.subjectcompanion diagnostic assaysen_US
dc.subjectexternal quality assessmenten_US
dc.subjectimmunohistochemistryen_US
dc.subjectnon-small cell lung canceren_US
dc.subjectpredictive testingen_US
dc.titleExternal quality assessment demonstrates that PD-L1 22C3 and SP263 assays are systematically different.en_US
dc.typeArticleen_US
dc.identifier.eissn2056-4538
dc.identifier.journalThe journal of pathology. Clinical researchen_US
dc.description.peer-reviewpeer-reviewen_US
dc.source.journaltitleThe journal of pathology. Clinical research
dc.source.volume6
dc.source.issue2
dc.source.beginpage138
dc.source.endpage145
refterms.dateFOA2021-08-16T15:01:35Z
dc.source.countryEngland


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