What is the sensitivity and specificity of rapid diagnostic tests for influenza?

Updated: Apr 23, 2019
  • Author: Hien H Nguyen, MD, MS; Chief Editor: Michael Stuart Bronze, MD  more...
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Answer

The US Food and Drug Administration (FDA) has waived federal Clinical Laboratories Improvement Act (CLIA) requirements and cleared for marketing 7 rapid influenza diagnostic tests that directly detect influenza A or B virus–associated antigens or enzyme in throat swabs, nasal swabs, or nasal washes. These tests can produce results within 30 minutes. [38]

A meta-analysis examining the accuracy of rapid influenza diagnostic tests found a pooled sensitivity of 62% and specificity of 98%. [39] The tests tended to be more sensitive in children (67%) than in adults (54%) and better at detecting influenza A (65%) than influenza B (52%).

The accuracy of these tests depends in part on the collection technique and skill of the person performing the test. Nasal swabs must be deeply inserted and then swirled to attach the influenza virus.


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