Diagnostic Tests

Anti‐dsDNA Test (for quantitative SLE disease activity)

ANTIGENS / BIOMARKERS

Anti-Double Stranded DNA / dsDNA (IgG)

TURNAROUND-TIME (TAT)

5 Days

SKU / TEST CODE

dsDNA

PROCEDURE / TECHNIQUE

Chemiluminescent Immunoassay (CIA)

REFERENCE RANGE

• Negative <35 IU/mL • Indeterminate 35-45IU/mL • Positive >45 IU/mL

SENSITIVITY / SPECIFICITY

TBD

CLINICAL ASSOCIATIONS

Mitogen’s Anti-dsDNA autoimmune diagnostic test is based on a Chemiluminescent immunoassay platform (CIA) and it detects autoantibodies against double-stranded DNA (dsDNA). dsDNA is present in all nucleated cells of the human body and when antibodies bind to circulating DNA forming immune complexes, they can localize in kidneys and other organs initiating inflammation and, if unchecked, organ failure in SLE. This diagnostic test has high specificity (>90%) and moderate sensitivity (10-40%) for the diagnosis of systemic lupus erythematous (SLE).

Reference: E. Mummert, M. J. Fritzler, C. Sjowall, C. Bentow, and M. Mahler. The clinical utility of anti-double-stranded DNA antibodies and the challenges of their determination. J.Immunol.Methods. 459:11-19, 2018.

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