Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay

Native DNA antibody (anti-nDNA) immunoassays are in vitro diagnostic tests designed to detect antibodies that target native DNA, often linked to autoimmune conditions like systemic lupus erythematosus (SLE). These fluorescent immunoassay kits analyze patient serum or plasma to help diagnose or monitor diseases where anti-nDNA antibodies are clinically significant.

These devices are typically regulated as in vitro diagnostics, with classification and supply varying by jurisdiction. They are generally supplied as kits containing reagents, controls, and instructions for use, requiring proper laboratory handling and interpretation by trained personnel.