Quidel Receives FDA Clearance for Its Point-of-Care Sofia® Lyme FIA

Quidel Corporation (“Quidel”), 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) 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,” said Douglas Bryant, president and chief executive officer of Quidel Corporation.

Lyme disease is the most common tickborne disease in North America and Europe1. In the United States, Lyme disease is caused by the bacterium, Borrelia burgdorferi, transmitted through the bite of an infected blacklegged tick. (1, 2)

Patients infected with B. burgdorferi may experience symptoms associated with three stages: early localized disease, early disseminated disease, and late persistent disease1. The most characteristic symptom of early localized disease is the appearance of erythema migrans (EM) on the skin1,3. EM may also be accompanied by flu-like symptoms days or weeks after infection3. In the second stage, early disseminated disease, untreated patients may begin to see neurological and rheumatological manifestations, and less commonly, dermatological, cardiac, or ophthalmological manifestations. These symptoms generally appear weeks to months after infection1. If the disease continues to be left untreated, late persistent disease may also follow months or years later with continued progression of manifestations in the joints, heart, skin, and nervous system. (2, 3)

Early detection and treatment of Lyme disease can help resolve symptoms and prevent progression of the disease1. The primary means of identifying B. burgdorferi infection is detection of the body’s IgM and IgG antibody response by way of immunoassay3. Detection of IgM antibodies to B. burgdorferi is generally most significant in the earlier stages of the disease. Conversely, detection of IgG antibodies has proven to be significant for longer periods, as the antibodies may remain detectable years after infection.

The Sofia analyzer and Sofia Lyme FIA combine unique 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.

1. Wormser, G. P., Dattwyler, R. J., Shapiro, E. D., Halperin, J. J., Steere, A. C., Klempner, M. S., Nadelman, R. B. (2006). The Clinical Assessment, Treatment, and Prevention of Lyme Disease, Human Granulocytic Anaplasmosis, and Babesiosis: Clinical Practice Guidelines by the Infectious Diseases Society of America. Clinical Infectious Diseases, 43(9), 1089-1134.
2. CDC. http://www.cdc.gov/lyme/diagnosistesting/LabTest/TwoStep/index
3. Aguero-Rosenfeld, M. E., Wang, G., Schwartz, I., & Wormser, G. P. (2005). Diagnosis of Lyme Borreliosis. Clinical Microbiology Reviews, 18(3), 484-509.