FDA has granted premarket notification (510(k)) clearance for the Quanta Flash Rheumatoid Factor (RF) IgM and Quanta Flash RF IgA assays from Inova Diagnostics, San Diego, a leader in autoimmune disease diagnostic systems and reagents for the clinical laboratory. The chemiluminescent assays complement the company’s previously cleared Quanta Flash CCP3 assay, which detects anticitrullinated peptide antibodies (ACPAs).
The newly cleared tests increase the number of assays available on the company’s Bio-Flash instrument, a random-access chemiluminescent system for the autoimmune laboratory that delivers results in as little as 30 minutes. Bio-Flash offers a wide analytical measuring range and precise quantification, and is a step forward in the handling of routine, specialized, and stat immunology tests.

Rheumatoid arthritis (RA) affects approximately 1% of the global population and leads to progressive and permanent joint damage. Classification criteria from the American College of Rheumatology and the European League against Rheumatism include both RF and ACPA. RF IgM has been reported as the main isotype among confirmed RA patients, with a prevalence of 70% to 80%. While less prevalent than the IgM isotype, RF IgA has been associated with more severe erosive disease and an increased likelihood for Sjӧgren’s syndrome or other extraarticular manifestations.

There is value in testing for multiple RF isotypes, as the specificity and predictive value for RA increases when more than one isotype is positive.

Quanta Flash RF IgM and RF IgA are chemiluminescent immunoassays in human sera, and are indicated for the quantitative determination of IgM RF antibodies, and the semiquantitative determination of IgA RF antibodies, respectively. 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 RA.

For further information, visit Inova Diagnostics.