Infectious Disease Testing

Rapid Flu Test Reclassification

FDA’s concern over the sensitivity of current Rapid Influenza Detection Tests (RIDTs) has led to a reclassification proposal published in the Federal Register on May 22, 2014.² The standards of performance for the detection and management of infection proposed by the FDA include the following minimum clinical performance criteria:¹
(Click on the charts for a larger view)


*Individual RIDT specificity performance was not calculated within the FDA Recommendation Summary.

 

At a recent FDA Advisory Committee Meeting, FDA presented data summarizing the performance of each RIDT against the proposed performance standard.¹ Here's how it stacked up:

 

*FDA combined the performance data of each of the specimen types for each of the RIDTs to calculate sensitivity in aggregate.

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Page last updated: 12/30/2015 3:21:18 PM