'Interchangeability' of PD-L1 immunohistochemistry assays:a meta-analysis of diagnostic accuracy
| Autor: | Gilad W. Vainer, H. Wang, Julien Adam, Catherine L. Ross, Ka F. To, Gilbert Bigras, Diana N. Ionescu, Ming-Sound Tsao, Paul E. Swanson, Chao Li, Anthony W.H. Chan, Jin Haeng Chung, Zhaolin Xu, Katsuhiro Okuda, Marianne Ratcliffe, Rasmus Røge, Maria S. Tretiakova, Andreas H. Scheel, Marius Ilie, Hyun J. Lim, Gang Han, Daichi Fujimoto, Enrico Munari, Dirk Zielinski, Emina Torlakovic, Fred R. Hirsch, Penny J. Barnes, David L. Rimm, Ross A. Soo, Pierre Fiset, Christian Couture, Carol C Cheung |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
Contingency table Data abstraction Pathology medicine.medical_specialty Computer science MEDLINE Diagnostic accuracy Review Article Predictive markers Immunohistochemistry Interchangeability B7-H1 Antigen Pathology and Forensic Medicine 03 medical and health sciences 030104 developmental biology 0302 clinical medicine 030220 oncology & carcinogenesis Meta-analysis medicine Humans Medical physics Medline database Non-small-cell lung cancer Companion diagnostic |
| Zdroj: | Torlakovic, E, Lim, H J, Adam, J, Barnes, P, Bigras, G, Chan, A W H, Cheung, C C, Chung, J-H, Couture, C, Fiset, P O, Fujimoto, D, Han, G, Hirsch, F R, Ilie, M, Ionescu, D, Li, C, Munari, E, Okuda, K, Ratcliffe, M J, Rimm, D L, Ross, C, Røge, R, Scheel, A H, Soo, R A, Swanson, P E, Tretiakova, M, To, K F, Vainer, G W, Wang, H, Xu, Z, Zielinski, D & Tsao, M-S 2020, ' "Interchangeability" of PD-L1 immunohistochemistry assays : a meta-analysis of diagnostic accuracy ', Modern Pathology, vol. 33, no. 1, pp. 4-17 . https://doi.org/10.1038/s41379-019-0327-4 Modern Pathology |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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