Evaluation of 11 commercially available rapid influenza diagnostic tests--United States, 2011-2012

Abstract

Accurate diagnosis of influenza is critical for clinical management, infection control, and public health actions to minimize the burden of disease. Commercially available rapid influenza diagnostic tests (RIDTs) that detect the influenza virus nucleoprotein (NP) antigen are widely used in clinical practice for diagnosing influenza because they are simple to use and provide results within 15 minutes; however, there has not been a recent comprehensive analytical evaluation of available RIDTs using a standard method with a panel of representative seasonal influenza viruses. This report describes an evaluation of 11 Food and Drug Administration (FDA)-cleared RIDTs using 23 recently circulating influenza viruses under identical conditions in a laboratory setting to assess analytical performance. Most RIDTs detected viral antigens in samples with the highest influenza virus concentrations, but detection varied by virus type and subtype at lower concentrations. Clinicians should be aware of the variability of RIDTs when interpreting negative results and should collect test samples using methods that can maximize the concentration of virus antigen in the sample, such as collecting adequate specimens using appropriate methods in the first 24-72 hours after illness onset. The study design described in this report can be used to evaluate the performance of RIDTs available in the United States now and in the future.