The U.S. Food and Drug Administration has cleared the Image Navigator automated microscope through the 510(k) process, according to Immuno Concepts, a company focused on autoimmune diagnostic reagents and instrumentation.
The indirect immunofluorescent (IIF) test has long been the gold standard for determination of anti-nuclear antibodies (ANA). The Image Navigator eliminates the tedious labor of the IIF test, while still allowing the user to control the interpretation and reporting of the tests.
The proprietary software program controls a high quality LED fluorescent microscope with a motorized stage to simplify and organize indirect fluorescent antibody (IFA) testing. It automatically captures images of each specimen, sorts the images into “possible negative” and “possible positive” categories with a precision >97 percent, and displays them for final review and confirmation by the user.
Comprehensive separate review screens allow the user to assign multiple patterns, order and read titers, and order additional testing. The system is scalable and communicates with pipetting systems and with laboratory information system (LIS) hosts.
The ANA test screens for connective tissue disease, but the labor intensive nature and subjective interpretation of the fluorescent ANA assay have limited its use, according to Eric S. Hoy, PhD, SI(ASCP), chief scientific officer, Immuno Concepts, who added that 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 tasks of the fluorescent ANA, freeing the laboratory technician to perform other tasks until it is time to read and interpret the assay.
The system is based on a standard fluorescent microscope, and the ANA is performed using the same slides and reagents as are used in the company’s regular ANA kits. The slides can be read manually on any fluorescent microscope using standard techniques.