Method Description

Purified full-length recombinant human cytochrome P450 2D6 antigen is bound to the wells of a polystyrene microwell plate under conditions that will preserve the antigen in its native state. Pre-diluted controls and diluted patient sera are added to separate wells, allowing any liver/kidney microsomal antibodies type 1 present to bind to the immobilized antigen. Unbound sample is washed away, and an enzyme labeled anti-human IgG antibody (conjugate) is added to each well. A second incubation allows the enzyme labeled anti-human IgG antibody to bind any patient antibodies, which have become attached to the microwells. After washing away any unbound enzyme labeled anti-human IgG antibody, the remaining enzyme activity is measured by adding a chromogenic substrate and measuring the intensity of the color that develops. The assay is evaluated by spectrophotometrically measuring and comparing the color intensity that develops in the patient wells with the color in the calibrator wells. (Package insert: INOVA Diagnostics, Inc.; Revision 13; 10/2018)