Sacramento, June 1, 2023
Contact: Sean Williams

FDA Clearance for Immuno Concepts’ IgG Anti-nDNA Fluorescent Test System for use with the Image Navigator®

Immuno Concepts, a recognized pioneer in innovation of autoimmune diagnostic reagents and instrumentation, is pleased to announce that the United States Food and Drug Administration (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.

In the USA, schedule a web demonstration of our solution for total automation of IFA testing by emailing Outside the US, contact your local Immuno Concepts distributor.

About Immuno Concepts

In 1979, Immuno Concepts pioneered the clinical laboratory conversion from rodent tissue to HEp-2 cells for the detection of ANAs. The HEp-2000® followed as the only patented ANA substrate that combines modern molecular biology with the traditional immunofluorescent assay to improve sensitivity for detection of autoantibodies to the SS-A/Ro antigen. Immuno Concepts continues to put education first by creating the most reliable automated solution for routine IFA. The Image Navigator has been designed by laboratory personnel to be user-friendly, provide efficiency in reading and resulting the tests, and improve reproducibility and accuracy.

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About the Image Navigator®

Image Navigator® is a software program that controls a high-quality LED fluorescent microscope with a motorized stage to simplify and organize IFA testing. It automatically captures images of each specimen, sorts the images into positive and negative categories with a precision >97%, and displays them for final review and confirmation by the Medical Laboratory Scientist. Comprehensive separate review screens allow the MLS to assign multiple patterns, order and read titers, order additional testing within the Image Navigator® software, and be guided by the software using our pattern assistant learning tool. The system is scalable and communicates with various pipetting systems and LIS hosts.