{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,10]],"date-time":"2026-04-10T01:24:47Z","timestamp":1775784287076,"version":"3.50.1"},"reference-count":35,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2019,12,17]],"date-time":"2019-12-17T00:00:00Z","timestamp":1576540800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["pathsocjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Pathology CR"],"published-print":{"date-parts":[[2020,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>PD\u2010L1 inhibitors are part of first line treatment options for patients with advanced non\u2010small cell lung cancer. PD\u2010L1 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\u2010L1 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 \u2018critical samples\u2019 near to clinical threshold cut\u2010offs. An expert panel (<jats:italic>n<\/jats:italic> = 4) evaluated all returned slides simultaneously and independently on a multi\u2010header microscope together with the participants own in\u2010house control material. The tonsil sample was evaluated as \u2018acceptable\u2019 or \u2018unacceptable\u2019, and for the other samples the percentage of PD\u2010L1 stained tumour cells were estimated in predetermined categories (&lt;1%, 1 to &lt;5%, 5 to &lt;10%, 10 to &lt;25%, 25 to &lt;50%, 50 to &lt;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 \u2018critical samples\u2019, in runs A and B, 22C3 IHC had significantly higher PD\u2010L1 expression than SP263 IHC (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001), whilst the PD\u2010L1 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 (<jats:italic>p<\/jats:italic> = 0.01). After the initial testing, improvement in performance of PD\u2010L1 IHC is shown for approved and LDT PD\u2010L1 assays. Equivalency of approved PD\u2010L1 22C3 and SP263 assays cannot be assumed as the scores cross the clinically relevant thresholds of 1% and 50% PD\u2010L1 expression.<\/jats:p>","DOI":"10.1002\/cjp2.153","type":"journal-article","created":{"date-parts":[[2019,12,18]],"date-time":"2019-12-18T00:09:20Z","timestamp":1576627760000},"page":"138-145","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":33,"title":["External quality assessment demonstrates that PD\u2010L1 22C3 and SP263 assays are systematically different"],"prefix":"10.1002","volume":"6","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7443-2362","authenticated-orcid":false,"given":"Andrew","family":"Dodson","sequence":"first","affiliation":[{"name":"UK National External Quality Assessment Scheme for Immunocytochemistry and In\u2010Situ Hybridisation  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Suzanne","family":"Parry","sequence":"additional","affiliation":[{"name":"UK National External Quality Assessment Scheme for Immunocytochemistry and In\u2010Situ Hybridisation  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Birgit","family":"Lissenberg\u2010Witte","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Biostatistics Amsterdam UMC, Vrije Universiteit Amsterdam  Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alex","family":"Haragan","sequence":"additional","affiliation":[{"name":"Department of Pathology Royal Liverpool and Broadgreen University Hospitals  Liverpool UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Allen","sequence":"additional","affiliation":[{"name":"HSL\u2010Advanced Diagnostics  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anthony","family":"O'Grady","sequence":"additional","affiliation":[{"name":"Department of Pathology Royal College of Surgeons in Ireland, Beaumont Hospital  Dublin Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emma","family":"McClean","sequence":"additional","affiliation":[{"name":"Oncology, Haematology and Cellular Pathology Guy's and St Thomas' NHS Foundation Trust  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jamie","family":"Hughes","sequence":"additional","affiliation":[{"name":"UK National External Quality Assessment Scheme for Immunocytochemistry and In\u2010Situ Hybridisation  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Keith","family":"Miller","sequence":"additional","affiliation":[{"name":"UK National External Quality Assessment Scheme for Immunocytochemistry and In\u2010Situ Hybridisation  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erik","family":"Thunnissen","sequence":"additional","affiliation":[{"name":"Department of Pathology Amsterdam UMC, Vrije Universiteit Amsterdam  Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2019,12,17]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.5858\/arpa.2017-0388-CP"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdy275"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1709937"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.12455"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1801005"},{"key":"e_1_2_7_7_1","volume-title":"IASLC atlas of PD\u2010L1 testing in lung cancer","author":"Tsao M\u2010S","year":"2017"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.lungcan.2017.09.010"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.5858\/arpa.2018-0410-ED"},{"key":"e_1_2_7_10_1","unstructured":"Horizon Discovery Ltd: CD274 (PD\u2010L1) Expression IHC Reference Standard. 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