Grifols, Barcelona, Spain, has added two immunofluorescence assays to its autoimmune disease portfolio in the United States, both for use with the Helios automated immunofluorescence assay system. The Helios system processes and reads immunofluorescence assay slides on a single platform, enabling laboratories to standardize the diagnosis of autoimmune diseases and return to the gold-standard method for autoimmunity screening.
Recently cleared by FDA, the Aeskuslides anti-neutrophil cytoplasmic antibody (ANCA) test and the Aeskuslides Crithidia luciliae nuclear DNA (nDNA) test are both indirect immunofluoresence assays. The ANCA assay detects anti-neutrophil cytoplasmic autoantibodies in human serum and aids in the diagnosis of ANCA-associated vasculitis, such as Churg-Strauss syndrome, granulomatosis with polyangiitis (Wegener’s Disease), and microscopic polyangiitis. The Crithidia luciliae assay detects IgG antibodies to native double helix DNA in human serum of lupus patients.
The Aeskuslides assays and Helios system are manufactured by Aesku Diagnostics, Wendelsheim, Germany, and Oakland, Calif. Grifols is the exclusive US distributor of Aesku’s autoimmune disease products and the Helios system. Grifols will begin commercializing the Aeskuslides ANCA and Crithidia luciliae assays in the United States early this summer.
Carsten Schroeder, Grifols.
The absence of a single diagnostic test for any autoimmune disease presents a challenge for diagnosis. Laboratories often use immunofluorescence assays to check for individual antibodies that are more disease specific. For vasculitis, samples for ANCA are initially tested by immunofluorescence on neutrophils to detect cytoplasmic or perinuclear staining patterns. For lupus, the most common tests employ an immunofluorescence assay with a target antigen dsDNA to help confirm a diagnosis. The Helios system uses Aeskuslides immunofluorescence assays, such as the ANCA and nDNA tests, to detect individual antibodies in human serum.
FDA’s recent clearance of the two assays follows the 2016 clearance of Aesku’s assay for anti-nuclear antibodies using human epithelial cells (ANA HEp-2) for use with the Helios instrument.
“The ANCA and nDNA assays provide clinical laboratories with an efficient and reliable way to test for autoimmune diseases such as vasculitis and lupus,” says Carsten Schroeder, president of the diagnostic division at Grifols. “The addition of these assays to our current portfolio, which includes ANA HEp-2, enables our customers performing immunofluoresence assays to detect anti-dsDNA and ANCA using one automated, immunofluoresence assay platform. With these assays approved, the Helios now has the largest FDA-cleared immunofluoresence assay menu of any immunofluoresence assay reader.
For more information, visit Grifols.
