Phadia has received FDA 510K clearance for four new EliA autoimmune antibody assays. These new assays will provide physicians with additional tools needed to aid in the diagnosis of Antiphospholipid Syndrome (APS). The newly available EliA assays, anti-cardiolipin (aCL) IgG/IgM and anti-B2-glycoprotein 1 (anti-B2-GP1) IgG/IgM, have proven to be essential, sensitive, and specific markers to aid in the diagnosis of APS.

Gabi Gross, autoimmune franchise leader of Phadia US, says, “Since its inception in 1967, Phadia has set the standard in the detection and diagnosis of allergies. Now, with the introduction of the EliA autoimmune product line in the United States, we are providing laboratories and clinicians with the same standard providing diagnostic tools with high performance assays to support the diagnosis of autoimmune diseases such as antiphospholipid syndrome.”

The clearances extend Phadia’s product line of CLIA Moderately Complex assays in the EliA autoimmune product line. Other commercially-available EliA assays include Cyclic Citrullinated Peptide (CCP), tissue Transglutaminase (tTG) IgA and IgG (Celikey), Gliadin IgA and IgG, dsDNA, Extractable Antinuclear Antibody (Symphony), and ENA antibodies to the following antigens: Sm, U1RNP, RNP70, Ro, La, Scl-70, CENP and Jo-1.

The EliA assays are available on the Phadia Laboratory Systems Phadia 100Є and Phadia 250 and feature a quick turnaround time, are performed under master curves with monthly calibration, have on board instrument dilution capability, and are performed using a discrete, single well, random access, non-microtiter plate format.