Quidel Receives FDA Clearance, CLIA Waiver for Its Point-of-Care Sofia® 2 Lyme Fluorescent Immunoassay

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 and Clinical Laboratory Improvement Amendments (CLIA) waiver from the United States Food and Drug Administration (FDA) to market its Sofia 2 Lyme FIA to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from finger-stick whole blood specimens from patients suspected of B. burgdorferi infection. The test is intended for use with the Sofia 2 analyzer to aid in the diagnosis of Lyme disease.

Sofia 2 is Quidel’s next-generation version of its best-selling Sofia instrumented system. Sofia 2 utilizes the original Sofia’s fluorescent chemistry design while improving upon the graphical user interface and optics system to provide an accurate, objective and automated result in as few as 3 minutes. Sofia 2 also integrates wireless connectivity and its barcode scanner within a smaller footprint than the legacy Sofia instrument. The next-generation Sofia 2 system also comes connected to Virena®, Quidel’s data management system, which provides aggregated, de-identified testing data in near real-time.

Lyme disease is the most common tickborne disease in North America and Europe [1]. 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 disease [1]. The most characteristic symptom of early localized disease is the appearance of erythema migrans (EM) on the skin [1,3]. EM may also be accompanied by flu-like symptoms days or weeks after infection [3]. 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 infection [1]. 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 disease [1]. The primary means of identifying B. burgdorferi infection is detection of the body’s IgM and IgG antibody response by way of immunoassay [3]. 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 2 Lyme FIA uses a bi-directional test strip format to detect both IgM and IgG antibodies to B. burgdorferi from a single finger-stick whole blood sample. One side of the test strip detects IgM antibodies to B. burgdorferi and the other side of the test strip detects IgG antibodies to B. burgdorferi.

The Sofia 2 Lyme FIA is also novel in that it can process samples from less invasive finger-stick whole blood specimens instead of blood samples collected though venipuncture, the traditional method of sample collection for Lyme testing. The assay’s whole blood sample processing technology speeds the time to diagnosis, is less invasive to the patient, and allows the test to be CLIA waived by the FDA.

CLIA waiver for the Sofia 2 Lyme FIA markedly expands the available market for the Sofia 2 test system, which allows the test to be run in physician offices, as well as in several thousand hospitals, medical centers, smaller clinics, and alternate sites (e.g., urgent care centers, free standing emergency departments, retail clinics, etc.) in the United States.

“The Sofia 2 Lyme FIA’s 510(k) clearance and CLIA Waiver for use on the Sofia 2 instrument will allow healthcare workers to generate a result in a single office visit, accelerating the time to diagnosis and potential treatment of Lyme Disease for the patient. 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 results,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “We expect that this new product introduction will increase the value of our Sofia 2 platform, and could create incremental instrument placement opportunities in traditional healthcare institutions that are closer to the patient, as well as in the rapidly growing alternate site segment of point of care.”

The Sofia 2 Lyme FIA is the fourth Sofia test for use on the Sofia 2 system that has been 510(k) cleared and CLIA waived by the FDA: the Sofia Influenza A+B FIA, the Sofia RSV FIA, and the Sofia Strep A+ FIA were 510(k) cleared and CLIA waived by the FDA in 2017. Quidel also markets the moderately complex Sofia Lyme FIA in the US, as well as Sofia Legionella FIA and Sofia S. pneumoniae FIA in Europe.

References

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.