ANA-Detecting Microscope Cleared by FDA

The Image Navigator automated microscope from diagnostic instrumentation developer Immuno Concepts Inc. has been cleared by the U.S. Food and Drug Administration as being safe and effective.

The Image Navigator eliminates the labor of indirect immunofluorescent testing for the determination of antinuclear antibodies (ANA) while still allowing the user to control the interpretation and reporting of these tests. The software program controls a high-quality LED fluorescent microscope with a motorized stage to simplify and organize indirect fluorescent antibody testing.

"The ANA test is an outstanding screening test for connective tissue disease, but the labor intensive nature and subjective interpretation of the fluorescent ANA assay have limited its use,” said Eric S. Hoy, chief scientific officer at Immuno Concepts. “Previous attempts to automate the ANA test using other immunoassay techniques have fallen short of the fluorescent ANA. The Image Navigator combines traditional fluorescent microscopy with modern digital technology to eliminate the repetitive, monotonous tasks of the fluorescent ANA.”

Immuno Concepts manufactures and distributes diagnostic assays for systemic rheumatic diseases.