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Quidel's Influenza Assay Approved in Japan

NEW YORK (360Dx) – Quidel on Wednesday announced it has received approval from Japanese regulators for the use of the company's Sofia Influenza A+B Fluorescent Immunoassay on the Sofia Fluorescent Immunoassay Analyzer.

The approval came from Japan's Pharmaceuticals and Medical Devices Agency. An estimated 13 million to 16 million cases of influenza in Japan were confirmed each year between 2010 and 2014, Quidel said.

Quidel's assay is based on lateral flow and immunofluorescence technologies and provides enhanced clinical sensitivity for influenza A and B, while the firm's Sofia Analyzer provides for high-throughput batching methods. It can be used in various healthcare settings, such as hospitals, medical centers, small clinics, and physician offices, Quidel said.

In combination, the assay and the system yields objective results that can be accessed on the instrument's screen in a hard copy printout, as well as a transmissible electronic form "that can network via an LIS system to hospital and medical center databases," it added.