Method Description

Purified cardiolipin antigen is bound to the wells of a polystyrene microwell plate under conditions that will preserve the antigen in its native state. Prediluted controls and diluted patient sera are added to separate wells, allowing any cardiolipin antibodies present to bind to the immobilized antigen. Unbound sample is washed away, and an enzyme-labeled antihuman IgM or IgG conjugate is added to each well. A second incubation allows the enzyme-labeled antihuman IgM or IgG to bind to any patient antibodies that have become attached to the microwells. After washing away any unbound enzyme-labeled antihuman IgM or IgG, the remaining enzyme activity is measured by adding a chromogenic substrate and measuring the intensity of the color that develops. After stopping the enzymatic production of colored product, the presence or absence of cardiolipin antibody is determined by comparing the sample optical density with that of a 5-point calibration curve. Results are reported out semiquantitatively in standard IgM or IgG anticardiolipin units.(Package inserts: QUANTA Lite ACA IgM III. Inova Diagnostics; Version 23, 08/2020; QUANTA Lite ACA IgG III. Inova Diagnostics; Version 23, 02/2019)