New Standards for Influenza Tests

Friday, September 13, 2013

This summer a meeting of the CDRH Microbiology Devices Advisory Committee was held to discuss classification of rapid antigen influenza detection tests. Along with the classification discussion, the issues of minimum acceptable performance criteria, the appropriate reference method to use to demonstrate performance, the need for annual monitoring for analytical reactivity after clearance and needed provisions for emergency situations were discussed. 

The minimum performance criteria proposals definitely made the largest splash and for a few manufacturers this may be a challenging bar to reach. For those currently in trials and not likely to meet the new bar (see below) you may still have a small chance of making it through as the new Special Controls document will take a little while to publish. However, it may not be worth continuing as there will be only a short period where less-than performance will be tolerated both by FDA and market place. Many manufacturers will be thrilled, however, with the news that FDA is moving towards comparison with other other cleared methods or reference methods other than culture. Given the variability of culture across labs this will be welcome news for everyone.

FDA made the following recommendations for the minimum levels for sensitivity and specificity when compared to an appropriate reference method (or percent agreement when compared to a compator method):

a. When compared to viral culture as the reference method:

Sensitivity

Flu A: Point estimate of 90% with 80% lower bound of the 95% confidence interval

Flu B: Point estimate of 80% with 70% lower bound of the 95% confidence interval Specificity

All influenza detection devices should demonstrate specificity with a lower bound of the 95% confidence interval exceeding 90% for both, Flu A and Flu B.

b. When compared to a molecular comparator method:

Sensitivity

Flu A: Point estimate of 80% with 70% lower bound of the 95% confidence interval

Flu B: Point estimate of 80% with 70% lower bound of the 95% confidence interval

Specificity

All influenza detection devices should demonstrate a specificity estimate with a lower bound of the 95% confidence interval exceeding 90% for both, influenza A and influenza B.

FDA stated that these proposed criteria for sensitivity are based on the performance of rapid influenza devices cleared in the last 5 years and the majority of these devices meet the proposed criteria.

Tags: Clinical Studies, FDA, Policy

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