Consensus guidelines on anti-cardiolipin antibody testing and reporting.
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.
Wong
Richard C W
RC
Division of Immunology, Queensland Health Pathology Services, Princess Alexandra and Royal Brisbane Hospitals, Qld., Australia. richard_wong@health.qld.gov.au
Gillis
David
D
Adelstein
Stephen
S
Baumgart
Karl
K
Favaloro
Emmanuel J
EJ
Hendle
Michelle J
MJ
Homes
Paul
P
Pollock
Wendy
W
Smith
Stewart
S
Steele
Richard H
RH
Sturgess
Allan
A
Wilson
Robert J
RJ
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
D017153:Antibodies, Anticardiolipin