Diagnostic Tests

CLINICAL ASSOCIATIONS

Commonly referred to as an antinuclear antibody test (ANA), Mitogen’s Anti-Cellular Antibody test is based on the Indirect immunofluorescence Assay (IFA) utilizing a slide containing HEp-2 cells. However, the identifiable and reported microscopy patterns are not limited to the traditional nuclear targets but rather include the numerous and clinically relevant cellular patterns including patterns observed at different stages of the cell cycle. After a patient’s sample is incubated with the cells, the presence of antibodies that target cellular components are identified by automated pattern-recognition microscopy, which are validated by direct observation of the IFA images. Antibody titers are determined by a digital algorithm that has been validated in several published studies. In some cases reflex testing with a solid phase immunoassay is recommended.

Anti-cellular antibodies are associated with a spectrum of autoimmune diseases including systemic lupus erythematous (SLE), mixed connective tissue disease, Sjögren’s syndrome, scleroderma, inflammatory and necrotising myopathies, neurologic SLE, juvenile arthritis, autoimmune liver diseases, drug-induced autoimmunity, and other conditions.

Reference: Agmon-Levin N, et al. Ann.Rheum.Dis. 73:17-23, 2014; Damoiseaux J, et al. Ann.Rheum.Dis. 78:879-889, 2019.