This is a companion article to the feature, “Reclassification of RIDTs.”

US public health officials strongly urge annual influenza vaccination for everyone beginning at age 6 months, but coverage rates are far from optimal. Nearly 6 in 10 US adults and 4 in 10 US children skip the annual inoculation.8 Furthermore, vaccination lowers the risk of infection, but does not eliminate it completely. Influenza vaccine effectiveness has been estimated from a low of 10% during the 2004–2005 season to a high of 60% during the 2010–2011 season.9,10

Such modest efficacy levels coupled with high rates of vaccine avoidance mean tens of millions of Americans will become infected and descend on the healthcare system every winter respiratory season. Healthcare providers face the very difficult task of differentiating influenza from other winter viruses, such as coronavirus, human metapneumovirus, respiratory syncytial virus (RSV), and rhinoviruses, and also from bacterial infections. Rapid and accurate point-of-care testing is essential to improving this process, and the new FDA reclassification should be welcomed by all who care about improving patient outcomes.