Nov. 27, 2017—Quidel received 510(k) clearance from the United States Food and Drug Administration to market its Sofia Lyme FIA for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from serum and plasma specimens from patients suspected of B. burgdorferi infection. The test is intended for use with the Sofia analyzer to aid in the diagnosis of Lyme disease.
“With the clearance of the Sofia Lyme FIA, we are now able to detect the microorganism associated with Lyme disease more rapidly in near patient settings. This is another example of our ability to provide simple, cost-effective solutions for physician offices and hospitals that previously had to wait several days for send-out Lyme results,” Douglas Bryant, president and chief executive officer of Quidel, said in a statement.
The Sofia analyzer and Sofia Lyme FIA combine immunofluorescence chemistry, advanced lateral flow technology, and failure alert and fail-safe systems designed to ensure reliable, objective, diagnostic results within 10 minutes of application of the patient’s specimen. The Sofia Lyme FIA is the first to provide differentiated results for both IgM and IgG on a single test, according to the company.