@article{00006e1b5d2a487eb571c87e87b7e3c8,
title = "“Interchangeability” of PD-L1 immunohistochemistry assays: a meta-analysis of diagnostic accuracy",
abstract = "Different clones, protocol conditions, instruments, and scoring/readout methods may pose challenges in introducing different PD-L1 assays for immunotherapy. The diagnostic accuracy of using different PD-L1 assays interchangeably for various purposes is unknown. The primary objective of this meta-analysis was to address PD-L1 assay interchangeability based on assay diagnostic accuracy for established clinical uses/purposes. A systematic search of the MEDLINE database using PubMed platform was conducted using “PD-L1” as a search term for 01/01/2015 to 31/08/2018, with limitations “English” and “human”. 2,515 abstracts were reviewed to select for original contributions only. 57 studies on comparison of two or more PD-L1 assays were fully reviewed. 22 publications were selected for meta-analysis. Additional data were requested from authors of 20/22 studies in order to enable the meta-analysis. Modified GRADE and QUADAS-2 criteria were used for grading published evidence and designing data abstraction templates for extraction by reviewers. PRISMA was used to guide reporting of systematic review and meta-analysis and STARD 2015 for reporting diagnostic accuracy study. CLSI EP12-A2 was used to guide test comparisons. Data were pooled using random-effects model. The main outcome measure was diagnostic accuracy of various PD-L1 assays. The 22 included studies provided 376 2×2 contingency tables for analyses. Results of our study suggest that, when the testing laboratory is not able to use an Food and Drug Administration-approved companion diagnostic(s) for PD-L1 assessment for its specific clinical purpose(s), it is better to develop a properly validated laboratory developed test for the same purpose(s) as the original PD-L1 Food and Drug Administration-approved immunohistochemistry companion diagnostic, than to replace the original PD-L1 Food and Drug Administration-approved immunohistochemistry companion diagnostic with a another PD-L1 Food and Drug Administration-approved companion diagnostic that was developed for a different purpose.",
author = "Emina Torlakovic and Lim, {Hyun J.} and Julien Adam and Penny Barnes and Gilbert Bigras and Chan, {Anthony W.H.} and Cheung, {Carol C.} and Chung, {Jin Haeng} and Christian Couture and Fiset, {Pierre O.} and Daichi Fujimoto and Gang Han and Hirsch, {Fred R.} and Marius Ilie and Diana Ionescu and Chao Li and Enrico Munari and Katsuhiro Okuda and Ratcliffe, {Marianne J.} and Rimm, {David L.} and Catherine Ross and Rasmus R{\o}ge and Scheel, {Andreas H.} and Soo, {Ross A.} and Swanson, {Paul E.} and Maria Tretiakova and To, {Ka F.} and Vainer, {Gilad W.} and Hangjun Wang and Zhaolin Xu and Dirk Zielinski and Tsao, {Ming Sound}",
note = "Publisher Copyright: {\textcopyright} 2019, The Author(s).",
year = "2020",
month = jan,
day = "1",
doi = "10.1038/s41379-019-0327-4",
language = "אנגלית",
volume = "33",
pages = "4--17",
journal = "Modern Pathology",
issn = "0893-3952",
publisher = "Elsevier B.V.",
number = "1",
}
