title: Consensus guidelines on anti-cardiolipin antibody testing and reporting.
abstract: Consensus guidelines on anti-cardiolipin antibody (aCL) testing have been developed to help minimise laboratory variation in the performance and reporting of aCL assays. These guidelines include minimum, optimum and optional recommendations for the following aspects of aCL testing and reporting: (1) isotype of aCL tested; (2) specimen type; (3) controls and assay precision; (4) calibrators; (5) patient samples; (6) rheumatoid factors and IgM aCL testing; (7) reporting of results; (8) cut-off values; and (9) interpretative comments.
  
  
  BACKGROUND
  aCL, anti-cardiolipin antibodies; APS, anti-phospholipid antibody syndrome; ASCIA, Australasian Society of Clinical Immunology and Allergy; ASTH, Australasian Society of Thrombosis and Haemostasis; beta2-GPI=beta2-glycoprotein I; ELISA, enzyme-linked immunosorbent assay; NCCLS, National Committee for Clinical Laboratory Standards; HSANZ, Haematology Society of Australia and New Zealand; QAP, Quality Assurance Program; RCPA, Royal College of Pathologists of Australasia; %CV, inter-assay inter-run coefficient of variation.
authors.affiliation: Division of Immunology, Queensland Health Pathology Services, Princess Alexandra and Royal Brisbane Hospitals, Qld., Australia. richard_wong@health.qld.gov.au
authors.forename: Richard C W
authors.initials: RC
authors.lastname: Wong
authors.forename: David
authors.initials: D
authors.lastname: Gillis
authors.forename: Stephen
authors.initials: S
authors.lastname: Adelstein
authors.forename: Karl
authors.initials: K
authors.lastname: Baumgart
authors.forename: Emmanuel J
authors.initials: EJ
authors.lastname: Favaloro
authors.forename: Michelle J
authors.initials: MJ
authors.lastname: Hendle
authors.forename: Paul
authors.initials: P
authors.lastname: Homes
authors.forename: Wendy
authors.initials: W
authors.lastname: Pollock
authors.forename: Stewart
authors.initials: S
authors.lastname: Smith
authors.forename: Richard H
authors.initials: RH
authors.lastname: Steele
authors.forename: Allan
authors.initials: A
authors.lastname: Sturgess
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Wilson
mesh_terms: D017153:Antibodies, Anticardiolipin / Q000097:blood*; D001315:Australia; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods / Q000592:standards*; D006801:Humans; D009520:New Zealand; D011785:Quality Assurance, Health Care / Q000592:standards*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D017153:Antibodies, Anticardiolipin