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Quidel Point of Care Lyme Disease Test Gets CE Mark

NEW YORK (360Dx) – Quidel announced late Tuesday that it's point-of-care Sofia 2 Lyme+ fluorescent immunoassay has received CE mark. The test has been tailored to the European market.

Quidel received clearance and CLIA waiver from the US Food and Drug Administration for its Sofia 2 Lyme test earlier this year.   

Like that assay, the Lyme+ test is a fluorescent immunoassay that runs on the Sofia 2 automated point-of-care immunoassay reader system. While the Lyme+ test also detects human IgM and IgG antibodies to Borrelia burgdorferi, a common tick-borne pathogen in the US and Europe, it further adds detection of antibodies to Borrelia garinii, and Borrelia afzelii, which are tick-borne pathogens common in Europe. And while the US Lyme test can be used with finger-stick whole-blood specimens, the CE-marked Lyme+ assay is specified for use with serum and plasma specimens.

"With the addition of the antigens specific to the predominant Borrelia strains in Europe, the Sofia 2 Lyme+ assay's CE mark for use on the Sofia 2 instrument will allow healthcare workers to generate an accurate, faster result, thereby accelerating the diagnosis and potential treatment of Lyme disease for the patient," Quidel President and CEO Douglas Bryant said in a statement. "We expect that this new product introduction will increase the value and utilization of our Sofia 2 platform in Europe and could create incremental instrument placement opportunities in the near to medium term."

The firm also markets other Sofia immunoassays in the EU, including Influenza A+B, Respiratory Syncytial Virus (RSV), Group A Streptococcus, Legionella, and S. pneumoniae tests.