The Ongoing Evolution from Indirect Immunofluorescence to Multiplex Immunoassays and the Push for Automation in the Anti-Nuclear Antibody Testing Landscape
The Anti-Nuclear Antibody (ANA) Testing Market is undergoing a dynamic evolution, marked by a progressive technological shift away from the traditional gold standard of Indirect Immunofluorescence (IIF) towards highly automated, higher-throughput methods such as Multiplex Immunoassays (MIAs) and Enzyme-Linked Immunosorbent Assays (ELISAs). While IIF on HEp-2 cells provides valuable morphological information (the characteristic staining patterns, such as homogeneous or speckled), which aids in the initial screening for systemic autoimmune rheumatic diseases (SARDs) like Systemic Lupus Erythematosus (SLE) and Sjögren’s Syndrome, it remains a subjective, labor-intensive method reliant on highly skilled technicians for interpretation. The inherent variability in reading and reporting results across different laboratories has created a clinical imperative for standardization, which is being addressed by the newer, more quantitative technologies that offer objective numerical results for specific autoantibodies. This…
