Quidel Corporation
QDEL, a provider of rapid diagnostic testing solutions,
cellular-based virology assays and molecular diagnostic systems,
announced today that it has received 510(k) clearance from the United
States Food and Drug Administration (FDA) for its Sofia RSV FIA test
for use with the Sofia Analyzer for the rapid, objective detection of
respiratory syncytial virus (RSV) infections.
RSV is responsible for respiratory tract infections, principally
among pediatric and elderly populations. In the pediatric setting,
nearly half of all children become infected by RSV in their first
year of life. In the United States, RSV is estimated to be
responsible for 73,400 to 126,300 hospitalizations annually for
bronchiolitis and pneumonia among children younger than one year.(1)
Sofia is the brand name for Quidel's next-generation, immunoassay system. The Sofia Analyzer and Sofia RSV FIA employ unique
immunofluorescence chemistry, advanced lateral flow technology, and
failure alert and fail-safe systems designed to ensure a reliable,
objective, highly accurate, diagnostic result within fifteen (15)
minutes of application of the patient's specimen.
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