放射防护 采用外周血淋巴细胞胞质分裂阻滞微核 (CBMN) 试验进行生物剂量测定的实验室性能标准

[中文适用范围]： 本文件就以下方面提供指导：a) 客户和实验室个人信息的保密性；b) 实验室安全要求；c) 有助于根据 CBMN 检测产量和检测限估算剂量的校准源和校准剂量范围，用于建立参考剂量反应曲线的校准源和校准剂量范围；d) 为 CBMN 检测评分而进行的血液采集、培养、收获和样品制备；e) 评分标准；f) 将 BNC 中的微核频率转换为吸收剂量的估计值；g) 结果报告；h) 质量保证和质量控制；以及 i) 包含客户样品说明、样品问卷、显微镜评分数据表和样品报告的信息性附件。本文件不包括 CBMN 自动评分方法。 [外文原描述]： This document gives guidance on a) confidentiality of personal information for the customer and the laboratory, b) laboratory safety requirements, c) calibration sources and calibration dose ranges useful for establishing the reference dose-response curves that contribute to the dose estimation from CBMN assay yields and the detection limit, d) performance of blood collection, culturing, harvesting, and sample preparation for CBMN assay scoring, e) scoring criteria, f) conversion of micronucleus frequency in BNCs into an estimate of absorbed dose, g) reporting of results, h) quality assurance and quality control, and i) informative annexes containing sample instructions for customers, sample questionnaire, a microscope scoring data sheet, and a sample report. This document excludes methods for automated scoring of CBMN.