title: International reference reagents to standardise blood group genotyping: evaluation of candidate preparations in an international collaborative study.
abstract: OBJECTIVE
  The aim of the study was to evaluate, in an international collaboration, four lyophilised genomic DNA preparations, selected from genotyped and phenotyped donors by the study organisers, for their suitability to standardise and control blood group genotyping procedures for common ancestral Caucasian and Black African alleles.
  
  
  METHODS
  Twenty-nine laboratories performed 'blind' testing of replicated ampoules of the candidate reference reagents, RBC1 (10/232), RBC4 (10/236), RBC5 (10/238) and RBC12 (10/234), using a range of genotyping procedures, most commonly classical PCR using allele or sequence specific primers.
  
  
  RESULTS
  The majority of laboratories reported blood group genotypes in accordance with those determined by the study organisers and the serological phenotypes. Despite an overall high level of accuracy in genotyping, the identified errors and inconsistencies, and the limited genotyping capabilities of many laboratories, confirmed the need for validated reference materials to control test procedures.
  
  
  CONCLUSIONS
  The establishment of RBC1, RBC4, RBC5 and RBC12 as World Health Organization Reference Reagents will facilitate international standardisation of blood group genotyping and ensure that such tests are sufficiently sensitive and specific.
authors.affiliation: National Institute for Biological Standards and Control (NIBSC), Potters Bar, Herts, UK.
authors.forename: J
authors.initials: J
authors.lastname: Boyle
authors.forename: S J
authors.initials: SJ
authors.lastname: Thorpe
authors.forename: J R
authors.initials: JR
authors.lastname: Hawkins
authors.forename: C
authors.initials: C
authors.lastname: Lockie
authors.forename: B
authors.initials: B
authors.lastname: Fox
authors.forename: P
authors.initials: P
authors.lastname: Matejtschuk
authors.forename: C
authors.initials: C
authors.lastname: Halls
authors.forename: P
authors.initials: P
authors.lastname: Metcalfe
authors.forename: P
authors.initials: P
authors.lastname: Rigsby
authors.forename: S
authors.initials: S
authors.lastname: Armstrong-Fisher
authors.forename: A M
authors.initials: AM
authors.lastname: Varzi
authors.forename: S
authors.initials: S
authors.lastname: Urbaniak
authors.forename: G
authors.initials: G
authors.lastname: Daniels
mesh_terms: D001789:Blood Group Antigens / Q000032:analysis / Q000235:genetics*; D001788:Blood Grouping and Crossmatching / Q000379:methods* / Q000592:standards*; D003299:Cooperative Behavior; D005838:Genotype; D006386:Hemagglutination Tests / Q000379:methods* / Q000592:standards*; D006801:Humans; D007391:International Cooperation; D014944:World Health Organization
chemical_list: D001789:Blood Group Antigens