| 185
ELx800 Operator's Manual
Sample Human Anticardiolipin IgG Enzyme
Immunoassay Kit
(Standard Curve and Cutoff)
Intended Use
This assay is intended for the in vitro measurement of IgG anticardiolipin
antibodies in human serum, as an aid in the
diagnosis of antiphospholipid
syndrome (APS).
Sufficient materials are supplied to allow a maximum of 41 samples to be tested in
duplicate or 89 in single, with a standard curve and positive and negative controls.
Background
Anticardiolipin antibodies are found in a wide range of conditions either
transiently, in some infectious diseases, or more persistently in autoimmune
diseases such as systemic lupus erythematosus (SLE) and antiphospholipid
syndrome (APS). Anticardiolipin antibodies have also been associated with a
range of clinical conditions
including fetal loss, endocarditis, stroke, heart attack
and autoimmune haemolytic.
Principle of the Assay
Microwells are precoated with cardiolipin and cofactor. Standards, controls, and
patient samples are added to the wells, and autoantibodies recognizing cardiolipin
bind during the first incubation. After washing the wells to remove all unbound
proteins, conjugate is added. The conjugate binds to the captured human antibody,
and the excess unbound conjugate is removed by a further wash step. Substrate is
added that causes a blue reaction, thereby exposing the bound conjugate and
producing an intensity proportional to the concentration of autoantibody in the
sample. Phosphoric acid is added to each well to stop the reaction. This produces a
yellow end-point color, which is read at 450 nm.