Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)

Double-stranded DNA antibody (anti-dsDNA) IVD kits use enzyme immunoassay (EIA) technology to detect antibodies in patient samples that target double-stranded DNA. Clinically, these tests help diagnose and monitor autoimmune conditions like systemic lupus erythematosus (SLE) by identifying elevated anti-dsDNA levels, a key biomarker for disease activity.

These kits are typically regulated as in vitro diagnostics (IVDs) and may require compliance with standards like ISO 13485 or FDA 21 CFR Part 820, depending on the jurisdiction. They are sold as complete assay systems, including reagents, controls, and instructions, and are designed for use in clinical laboratories or specialized medical settings.