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Quidel POC Analyzer and Influenza A+B Assay Get CLIA Waiver, FDA Clearance

NEW YORK (360Dx) – Quidel said on Tuesday that the US Food and Drug Administration has given 510(k) clearance and a CLIA waiver for its Sofia Influenza A+B fluorescent immunoassay operating on the Sofia 2 analyzer.

The combination is cleared for use in the rapid, differential detection of Influenza types A and B from direct nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens, and nasopharyngeal swab and nasopharyngeal aspirate/wash specimens in transport media from symptomatic patients, Quidel said.

The firm noted that the receipt of a CLIA waiver markedly expands the available market for the Sofia 2 test system. The FDA previously announced clearance of the test to run on Sofia 2 in April.

“From our perspective, Sofia 2’s much lower manufacturing cost is an important benefit, as it will allow us to place instruments in an increased number of settings and to expand our reach,” Douglas Bryant, president and CEO of Quidel, said in a statement.

The Sofia Influenza A+B assay employs advanced lateral flow and immunofluorescence technologies to provide enhanced clinical sensitivity for Influenza A or B infections, the firm said.

The Sofia 2 fluorescent immunoassay analyzer — a next-generation system — employs the firm's "original fluorescent chemistry design" and improves on the graphical user interface and optics to provide an accurate, automated, and objective result in as few as three minutes, Quidel said. 

The original Sofia platform was CLIA waived in 2012 along with an influenza A+B test, and the firm has since received CLIA waiver on its Sofia tests for Strep A and RSV.