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.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 4.1 General 4.2 Requests for analysis and blood sampling <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 6.1 Setup and sustainment of the quality assurance program 6.2 Responsibility during service <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 7.1 Overview 7.2 Applications of the principle of confidentiality 7.2.1 Delegation of responsibilities within the laboratory <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 7.2.2 Requests for analysis 7.2.3 Transmission of confidential information 7.2.4 Anonymity of samples 7.2.5 Reporting of results 7.2.6 Storage 7.2.7 Data security plan 8.1 Overview <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 8.2 Microbiological safety requirements 8.3 Chemical safety requirements <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 8.4 Optical safety requirements 8.5 Safety plan 9.1 Culturing <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 9.2 Staining 9.3 Microscopy 9.4 Scoring of slides 9.4.1 General 9.4.2 Criteria for scoring <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 9.4.3 Scoring data sheets 9.5 Automated analysis 10.1 Calibration source(s) 10.2 Calibration curve <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 10.3 Background MN frequency <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 10.4 Comparison with the background level: Characterisation of the minimum detectable dose <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 11.1 Procedure for scoring MN in BNCs 11.1.1 Coding of samples and slides <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 11.1.2 Scoring techniques 11.1.3 Laboratory scoring expertise 11.2 Criteria for converting a MN yield into an estimate of absorbed dose 11.2.1 Overview 11.2.2 Comparison with controls 11.2.3 Confidence limits on the number of MN 11.2.4 Calculation of absorbed dose for whole-body exposures <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 11.2.5 Calculation of uncertainty on absorbed dose 11.2.6 Acute and non-acute exposure cases <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 11.2.7 Testing the distribution of MN per BNC 11.2.8 Other exposure scenarios 11.3 Reporting of results 11.3.1 General 11.3.2 Content of the report (see Annex D for a standard form) <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 11.3.3 Interpretation of the results 12.1 General 12.2 Use of a CBMN assay network for large scale exposures <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 12.3 Procedure for scoring MN in BNCs 12.4 Criteria for converting a MN yield into an estimate of absorbed dose 12.5 Reporting of results 13.1 Overview 13.2 Specific requirement 13.2.1 General 13.2.2 Performance checks by laboratory inter-comparisons <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 13.2.3 Periodical performance check of scorer qualification 13.2.4 Performance checks of sample transport integrity 13.2.5 Performance checks of sample integrity by service laboratory 13.2.6 Performance checks for instrumentation <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | 13.2.7 Performance checks of sample protocol 13.2.8 Performance checks of sample scoring 13.2.9 Performance checks of dose and confidence limits estimation 13.2.10 Performance checks for result report generation <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Radiological protection. Performance criteria for laboratories using the cytokinesis-block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry<\/b><\/p>\n |