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18th September 2018  Content supplied by: Quidel Corporation

FDA Cleared Detection of Borrelia burgdorferi from Finger-Stick Whole Blood Specimens

Quidel Corporation 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.

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.

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Date Published: 18th September 2018

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