The FDA, through the 510(k) process, has cleared the Immuno Concepts IgG Anti-nDNA Fluorescent Test System for Image Navigator use.
This test kit was previously cleared for manual use over 40 years ago. The test kit aids in the qualitative and/or semi-quantitative determination of anti-double stranded DNA (dsDNA) IgG antibodies. The presence of anti-dsDNA antibodies can be used in conjunction with other serological and clinical findings to aid in the diagnosis of systemic lupus erythematosus (SLE).
According to Dr Eric Hoy, chief scientific officer for Immuno Concepts, “The indirect immunofluorescent antibody assay for detection of antibodies to dsDNA has been in use since 1975 and has been proven to be a valuable component for the diagnosis of systemic lupus erythematosus. The Immuno Concepts anti-nDNA test is widely used by laboratories throughout the world. Automating the reading of the slides with the Image Navigator will improve consistency and reproducibility of the assay. For laboratories using the Image Navigator system for Antinuclear Antibody (ANA) testing, the addition of the anti-nDNA to the testing regimen will be seamless and will provide additional information to assist the clinician in the diagnosis of autoimmune diseases.”
Automation using Immuno Concepts IgG Anti-nDNA Fluorescent Test System on the Image Navigator can significantly improve laboratory turnaround time and standardization, while reducing technician hands-on time for the detection and titering of anti-dsDNA antibodies.
Featured image: Immuno Concepts Image Navigator and AFT System. Photo: Immuno Concepts
