The Food and Drug Administration has granted marketing authorization for the Healgen Rapid Check™ immunodiffusion procedure that can simultaneously identify antigens to SARS-CoV-2, the virus responsible for COVID-19 and both influenza A and B viruses from nasal swabs.  The test can be self-administered by an adult and from children 2-years and older. 

As with all diffusion tests, sensitivity is slightly inferior to molecular (PCR) assays that requires submission of swabs to a laboratory with suitable equipment and trained personnel.  Notwithstanding the lower sensitivity attaining 92 percent for COVID and 91 percent for influenza A and B, the test has high specificity and will correctly report 99 percent of negative samples.  In the event of a negative test, there is reasonable assurance that the patient is not shedding either SARS-CoV-2 or influenza A or B virus as denoted by the result.  Unfortunately, the test will yield a small proportion of false negatives.

The combined test will be useful in differentiating between influenza and COVID allowing correct antiviral therapy especially for individuals with predisposing conditions or at risk based on age.

Dr. Michelle Tarver, Acting Director of the FDA Center for Devices and Radiologic Health noted, “As we enter this year’s annual flu season with respiratory illnesses such as COVID-19 on many of our minds, our ability to detect these pathogens effectively and efficiently can be impactful on our daily lives”.  The Rapid Check™ test kit will be valuable to screen workers and supervisors complaining of respiratory signs establishing an early diagnosis to initiate treatment and to implement quarantine especially in individuals that have not received seasonal vaccinations.