15.3: ABO typing by molecular genetics Whereas ABO typing by serological means is straightforward and extremely accurate, the genetics of ABO is complex, rendering ABO molecular typing b…
15.4: Methods available for molecular blood grouping 15.4.1: Fetal typing The usual technology employed for fetal blood group typing, in which the mother lacks the antigen to …
15.1: Introduction Genes for all of the blood group systems have been isolated and the molecular bases for most of the clinically important blood group antigens are known. So it is now p…
14.3: Working practices DNA should be as intact as possible. An archival record (e.g. photograph or electronic image) of each post-PCR run should be retained.
14.2: Avoidance of contamination DNA should be purified by a standard method that has been reported to the scientific literature and validated in the laboratory. DNA should be suitably s…
12.14: Manual testing A manual testing system is one in which the minimum automated testing criteria have not been met. Manual testing can be used to resolve anomalous r…
12.13: Automated testing An automated system as a minimum must accomplish the following: positive sample identification, reading and interpretation of results m…
12.11: Additional testing 12.11.1: Antibody identification Donations found to be reactive in the routine antibody screen may be further investigated for specificity.
12.12: Donations found to have a positive direct antiglobulin test Direct antiglobulin test (DAT) positive donations may be identified incidentally by testing laboratories when:
12.10: Mandatory testing of blood donations Blood groups shall be determined using reagents that comply with Chapter 11 of these guidelines. All mandatory tests must be performe…
12.9: Laboratory test categories Laboratory tests include the following categories: Mandatory tests – required as part of the criteria for release of all blood donations …
12.8: Release of tested components Standard procedures must ensure that blood and blood components cannot be released for issue until all the required laboratory tests (mandatory and add…
12.7: Reporting of results The report must indicate the result of each and every test, by a system that provides positive sample identification. Reporting a series of tests by a…
12.6: Test procedure Test procedures must: be validated before being introduced into routine use be written in the form of standard operating procedures <…
12.5: Equipment Test equipment should be validated before being introduced into routine use and procedures must be in place to ensure that test systems and equipment are able to produce …
12.4: Reagents and test kits Acceptance testing should be performed on each batch/delivery of reagents and test kits. Reagents and test kits should be stored and used according …
12.3: Samples Samples may be ethylenediamine tetra-acetic acid (EDTA) or clotted. Where equipment/reagent manufacturers have defined protocols for storage and preparation, then …
12.1: Scope These specifications provide guidance on the tests required for blood donations in the UK.
12.2: General requirements Secure and effective procedures must be in place to ensure that: Specific procedures are written in the form of standard operating procedures.<…
6.13: References Council of Europe (2023). Guide for the Preparation, Use and Quality Assurance of Blood Components, 21st edition. Council of Europe Publishing. …
6.12: Component recall and traceability There must be a documented system available in each Blood Establishment whereby adverse effects caused by the administration of any component, or …
6.9: Component release All components must be appropriately labelled in accordance with these guideline specifications including those general guidelines outlined in section 6.5 and Chap…
6.8: Non-conforming components and biohazards 6.8.1: Discard of non-conforming components (including outdated components) Procedures for the discard of non-conforming componen…
6.6: Labelling 6.6.1: Component labelling Barcoded labels and on-demand printing must be used whenever possible. The design, content and use of labels for blood compo…
6.5: Component shelf life Component storage specifications are given in Chapter 7. Where components are pooled or undergo procedures that influence the shelf life, the maximum s…