Quidel Corporation (San Diego, CA) received FDA clearance for its new benchtop fluorescent immunoassay analyzer, the Sofia, a device designed for rapid diagnoses of infectious diseases using fluorescent chemistry. The analyzer can be used in the laboratory or in point-of-care settings and uses a fluorescent tag that is illuminated by an ultraviolet (UV) light source to identify the assay specific target. The stronger the signal is, the higher the concentration of the target analyte present in the sample. After the patient sample has been added to the test cassette, the test is developed at room temperature. The cassette is then placed into the analyzer where it is scanned, and the fluorescent signal of the test is processed using an assay-specific algorithm.
Results can be stored in the analyzer, an external SD card or directly printed on an integrated printer. Of course, the Sofia also connects to the majority of existing laboratory information systems to update patient medical records instantly. An internal barcode scanner reads each test cassette to record sample data. The external barcode reader is used to scan patient and operator IDs.
The Sofia Influenza A+B Fluorescent Immunoassay is the first in a series of new immunofluorescent assays for infectious diseases that will be available for this new analyzer. They received their FDA clearance for this assay just in time for the new upcoming influenza season.
Both the Sofia Analyzer and the Sofia Influenza A+B FIA already received the CE Mark in August 2011, and are thus already available for sale in Europe.
Product page: Sofia Fluorescent Immunoassay Analyzer