FDA clears Histofluor slides

SACRAMENTO, Calif.—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 Histofluor Rodent LKS Tissue Slides for manual and Image Navigator use.

The indirect immunofluorescent (IIF) test has long been the preferred method for determination of Anti-Mitochondrial Antibodies, Anti-Smooth Muscle Antibodies, and Anti-Parietal Cell Antibodies. These autoantibodies are associated with several autoimmune diseases, including Pernicious Anemia or Autoimmune Gastritis, Primary Biliary Cholangitis, and Autoimmune Hepatitis. The FDA-cleared Immuno Concepts’ Histofluor Rodent Tissue Slides are available in both mouse and rat substrates and can be read manually or scanned using the innovative Image Navigator automated microscope.

The same slides and reagents for the Histofluor Rodent Tissue Slides are used regardless of whether the slides are read manually or scanned on the Image Navigator. There are no other ingredients or special conditions required. The previously FDA-cleared Image Navigator is a solution that eliminates the usual tedious labor of the IIF test, while still allowing the laboratory professional to control the interpretation and reporting of these tests.

“The new Histofluor Rodent LKS Fluorescent Antibody Test System improves on a diagnostic technique that dates back several decades. The Immuno Concepts kits do not require freezing of any component, including the tissue slides. The available positive controls and titratable controls provide assurance to the user that the patterns seen on the tissues are true evidence of the corresponding autoantibodies,” commented Eric S. Hoy, Ph.D., SI(ASCP), Chief Scientific Officer of Immuno Concepts.

“All of the components are ready-to-use and are identical whether the user runs the assay manually or on the Image Navigator. The Image Navigator captures multiple images of the three rodent tissues and assembles them into a panoramic view of the well. The user can apply the standard features of the Image Navigator to enlarge regions of the tissue to examine fine detail and determine the antibody specificity of the fluorescent staining. The new slides and the Image Navigator together eliminate much of the subjectivity formerly associated with this testing.”

In 1979, Immuno Concepts pioneered the industry conversion from rodent tissue to HEp-2 cells for detection of ANAs. Immuno Concepts followed up with HEp-2000, the only patented ANA substrate genetically enhanced to improve sensitivity for detection of autoantibodies to the SS-A/Ro antigen. Today, Immuno Concepts has the automated solution for IFA assays, the Image Navigator. Together the family of AFT pipetting instruments and Image Navigator can process a patient sample from collection tube to final result, with reportedly better reproducibility and accuracy than manual methods.