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FDA Clears Thermo Scientific EliA RNA Pol III and EliA Rib-P Tests for Use in U.S.


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Thermo Scientific EliA RNA Pol III and EliA Rib-P tests have been cleared by the U.S. Food & Drug Administration (FDA) for aiding in the diagnosis of Systemic Sclerosis (SSc; scleroderma) and Systemic Lupus Erythematosus (SLE). With these new tests, the EliA portfolio provides a more  robust clinical offering through a comprehensive menu of automated connective tissue disease tests.


“Autoimmune diseases can be a challenge to diagnose. Reliable and accurate laboratory tests that provide clinical clarity are essential tools for  clinicians  managing these patients,” said Dr. Henry Homburger, Professor Emeritus of Laboratory Medicine at Mayo Clinic College of Medicine, and laboratory director, Thermo Fisher Phadia Immunology Reference Laboratory. “The addition of RNA Polymerase III and Ribosomal P to the EliA connective tissue disease test menu will add considerable value to the diagnosis of SSc and SLE.”


RNA Polymerase III is a criteria marker for SSc with both diagnostic and prognostic value.[1, 2] Additionally, in patients who are positive for RNA Polymerase III, up to 70% may have no other SSc associated antibodies present.[2] The EliA RNA Pol III test completes a criteria based EliA SSc panel and is the first fully automated RNA Polymerase test available in the U.S.


A subset of SLE patients present with monospecific Ribosomal P antibodies.[3] Detection of these autoantibodies via indirect immunofluorescence has been shown to be an unreliable method, which if used  solely, could result in delayed diagnosis and treatment.[4] The EliA Rib-P test is designed with optimal sensitivity and specificity and can be used to support the diagnosis of SLE, particularly in ANA negative patients. [3, 4]


“The availability of a strong CTD test menu on a fully automated instrument could improve the efficiency and productivity of diagnostic laboratories,” added Homburger. “The new EliA RNA Pol III and EliA Rib-P tests have been designed to improve the differentiation of SSc and SLE from other connective tissue diseases. Targeting existing diagnostic care gaps can potentially lead to earlier and more accurate diagnosis and ultimately improve clinical outcomes for patients.”


References


1.           Van Den Hoogen, F., et al., 2013 Classification Criteria for Systemic Sclerosis: An American College of Rheumatology/European League Against Rheumatism Collaborative Initiative. Arthritis & Rheumatism, 2013. 65(11): p. 2737-2747.


2.           Wielosz, E., M. Dryglewska, and M. Majdan, Clinical consequences of the presence of anti-RNA Pol III antibodies in systemic sclerosis. Advances in Dermatology and Allergology, 2020. 37(6): p. 909-914.


3.           Carmona-Fernandes, D., et al., Anti-ribosomal P protein IgG autoantibodies in patients with systemic lupus erythematosus: diagnostic performance and clinical profile. BMC Medicine, 2013. 11(1): p. 98.


4.           Choi, M.Y., et al., A review and meta-analysis of anti-ribosomal P autoantibodies in systemic lupus erythematosus. Autoimmunity Reviews, 2020. 19(3): p. 102463.

  

 

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