标准摘要
[中文适用范围]: 本文件旨在为细胞遗传学服务实验室提供质量保证(QA)、质量控制(QC)和生物剂量测定性能评估的标准。本文件涉及:a) 客户和实验室的责任;b) 客户和实验室的个人信息保密性;c) 实验室安全要求;d) 样品处理;培养、染色和评分,包括 FISH 易位分析评分标准;e) 校准源和校准剂量范围,用于建立参考剂量反应曲线,有助于根据染色体畸变频率和检测限进行剂量估算;f) 用于评估暴露的 FISH 染色易位评分程序;g) 将测得的畸变频率转换为吸收剂量(也显示为“剂量”)估计值的标准;h) 结果报告;i) 质量保证和质量控制; j) 附件 A 至 F 包含客户样品说明、样品调查问卷、记录异常的样品数据表、报告样品以及通过最大似然法拟合低剂量反应曲线并计算剂量估计的不确定度。 [外文原描述]: The purpose of this document is to provide criteria for quality assurance (QA), quality control (QC) and evaluation of the performance of biological dosimetry by cytogenetic service laboratories. This document addresses: a) the responsibilities of both the customer and the laboratory; b) the confidentiality of personal information, for the customer and the laboratory; c) the laboratory safety requirements; d) sample processing; culturing, staining and scoring, including the criteria for scoring for translocation analysis by FISH; e) the calibration sources and calibration dose ranges useful for establishing the reference dose‑response curves that contribute to the dose estimation from chromosome aberration frequency and the detection limit; f) the scoring procedure for translocations stained by FISH used for evaluation of exposure; g) the criteria for converting a measured aberration frequency into an estimate of absorbed dose (also appears as "dose"); h) the reporting of results; i) the QA and QC; j) Annexes A to F containing sample instructions for the customer, sample questionnaire, sample datasheet for recording aberrations, sample of report and fitting of the low dose-response curve by the method of maximum likelihood and calculating the uncertainty of dose estimate.
英文名称Radiological protection — Performance criteria for laboratories using Fluorescence In Situ Hybridization (FISH) translocation assay for assessment of exposure to ionizing radiation