Assessment of Self-Collected Sample Compared to Clinician Collected Sample in COVID-19 and Influenza Program

In some research studies, saliva has been shown to be as good as or even better than an
anterior nares or nasopharyngeal specimen in detecting SARS-CoV-2; we are interested in
making sure that is the case. Being able to collect a specimen at home and mail it in would
help with patient compliance and would reduce the need for clinicians (nurses or other health
care professionals) to use personal protective equipment (PPE), which is in short supply.
Also, people would not have to go to a healthcare facility or other testing site to have the
COVID-19 or the Influenza A/Influenza B testing done. We are using a sensitive method
(RT-PCR) to look for the three viruses.

Once you have had the anterior nose swab collected by the study clinician, your participation
would last only as long as it takes to complete the self-collected saliva collection and
return the sample to the researchers. The self-collection of the saliva specimen should be
collected as soon as possible after the collection of anterior nares and saliva samples by
the clinician You will mail in the saliva swab in a prepaid mailer no later than 10 days
after sample collection and the result will be available within one day of our lab receiving
the swab. Once our lab receives your specimen, the gift card which you received will be
activated and your participation will be complete. Biocerna, LLC (Fulton, Maryland), is the
commercial laboratory to which the research subjects' samples will be shipped and tested.

We anticipate approximately 500 subjects will be enrolled. You qualify because you live in a
location which is reporting an increased number of COVID-19 positive cases. Incidence of
Influenza A/Influenza B is also useful to track to find out whether social distancing and/or
wearing masks decreases the number of Influenza A/Influenza B cases during the winter months.