Another layer of government oversight
By Joe Elia
Office-based tests for the rapid detection of influenza will shift from their "low-risk" classification to a higher-risk class that will mandate minimum clinical performance criteria and annual clinical testing, according to an FDA notice in the Federal Register and a report in The Hill.
The tests showed "poor performance" in the 2009 H1N1 pandemic, according to notes from an FDA advisory committee meeting held last June. Their performance "has often not matched the specifications provided in test labeling."
Given the serious public health implications of influenza outbreaks, tests not meeting the new requirements would be withdrawn from the market. Those requirements will include a sensitivity estimate of at least 90% for influenza A and 80% for influenza B; in addition, specificity must be at least 95%.