CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
August 2019—Inova Diagnostics announced FDA 510(k) clearance of its Quanta Flash RF IgM and Quanta Flash RF IgA assays. The chemiluminescent immunoassays are used in human sera and are indicated for the quantitative determination of IgM rheumatoid factor antibodies (Quanta Flash RF IgM) and the semiquantitative determination of IgA rheumatoid factor antibodies (Quanta Flash RF IgA). The presence of IgM or IgA anti-RF antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of rheumatoid arthritis.
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