临床与实验病理学杂志2025，Vol.41Issue(7)：918-923,6.DOI:10.13315/j.cnki.cjcep.2025.07.012
38家实验室EBER原位杂交室间质控结果分析
Analysis of the results of external quality control for EBER in situ hybridization in 38 laboratories
摘要
Abstract
Purpose The results of EBER in situ hybridization on the external quality assessment(EQA)organ-ized by the pathology Equipment Branch of the China Association of Medical Equipment were analyzed,for providing technical support for the standardization and normalization of the technology.Methods Paraffin-embedded sections of confirmed EBV-positive diffuse large B-cell lymphoma were selected as the evaluation specimens.Additionally,EBER in situ hybridization liquid cell controls were applied to the slides as evaluation references.A questionnaire was distrib-uted to collect staining information and methodologies from participating laboratories.Finally,the stained slides were collected and independently evaluated by pathology experts from the association according to predefined scoring criteria.Results A total of 38 pathology laboratories from 7 provinces and municipalities directly under the central government participated in the EQA,including 32 hospital pathology departments and 6 independent clinical laboratories.21 par-ticipants used manual staining,and others(17)used automated staining method by immunohistochemistry(IHC)stainers.The overall qualification rate of EBER in situ hybridization staining was 94.74％(36/38),and the excellent& good rate was 26.32％(10/38).The excellent & good rate of automated staining(41.12％,7/17)was significant-ly higher than that of manual staining(14.29％,3/21)(x2=4.852,P=0.028).The positive cell line control showed good consistency with the tissue control(Kappa=0.909,r=0.944).Conclusion The EBER in situ hybrid-ization technique in most of the pathology laboratories in the external quality assessment is qualified.There is a statisti-cally significant difference in the excellent & good rate between different staining methods.EBER in situ hybridization using automated IHC stainers is recommended as the preferred method.There is no difference in the performance of positive cell line control and tissue control.Some laboratories' staining techniques need to be improved.关键词
室间质控/原位杂交染色/EBER/组织阳性对照/液态细胞质控品Key words
external quality assessment/in situ hybridization staining/EBER/tissue positive control/liquid cell quality control sample分类
医药卫生引用本文复制引用
蔡晴,郭文阳,薛晓伟,王德田,王先博,周炜洵..38家实验室EBER原位杂交室间质控结果分析[J].临床与实验病理学杂志,2025,41(7):918-923,6.基金项目
中国医学科学院医学与健康科技创新工程项目(2023-I2M-C&T-B-003)、中央高水平医院临床科研专项(2022-PUMCH-B-062) Medical and Health Science and Technology Innovation Project of Chinese Academy of Medical Sci-ences(2023-I2M-C&T-B-003) （2023-I2M-C&T-B-003）
National High Level Hospital Clinical Research Funding(2022-PUMCH-B-062) （2022-PUMCH-B-062）
