Interlaboratory consistency analysis of clinical grading interpretation of tumor gene variants
10.13315/j.cnki.cjcep.2024.10.005
- VernacularTitle:肿瘤基因变异临床分级解读的实验室间一致性分析
- Author:
Lei DONG
1
;
Qianlan YAO
;
Xuqian FANG
;
Jiayi ZHENG
;
Anqi LI
;
Xiaoyan ZHOU
Author Information
1. 上海交通大学医学院附属瑞金医院病理科,上海 200025
- Keywords:
neoplasms;
gene variants;
interpretation;
agree-ments
- From:
Chinese Journal of Clinical and Experimental Pathology
2024;40(10):1027-1032
- CountryChina
- Language:Chinese
-
Abstract:
Purpose To investigate the consistency of the"Standards and guidelines for the interpretation and reporting of sequence variants in cancer"published in 2017 by the Associa-tion for Molecular Pathology(AMP)/American Society of Clini-cal Oncology(ASCO)/College of American Pathologists(CAP).Methods Sixty variants of 26 genes from 11 types of cancer were selected.5 professionals from four hospitals e-quipped with in-hospital NGS detection ability were used to in-terpret the treatment,diagnosis and progenosis respectivly.In the first phase of the study,each researcher rated the variants individually according to their own understanding of the 2017 guideline.In the second phase,the details of the guidelines'e-valuation principles were discussed and interpreted again after reaching a consensus.Results Eleven principles recognized by all participants were summarized as a supplement to interpreta-tion.Fleiss consistency showed that the consistency of interpre-tation of treatment and prognostic significance in the second stage was higher than that in the first phase(κ value was 0.166 vs 0.276,0.014 vs 0.185).The consistency of interpretation of diagnostic significance in the second stage was lower than that in the first phase(κ value was 0.454 vs 0.035).Conclusion There is inconsistency in the clinical interpretation of tumor gene variation among different laboratories.It is feasible for laborato-ries to establish a mutually recognized interpretation system for the clinical diagnosis,treatment,and prognosis of tumors.