In alignment with new guidance from the Food and Drug Administration that restricts the use of home-based COVID-19 test kits, the Key to Oregon study will temporarily delay the mailing of home-based test kits to study participants.
Instead, Key to Oregon will help people with COVID-19-like symptoms access testing services within the community.
It is important to note that the Key to Oregon study is not suspended in any way. Participation enrollment and symptom monitoring will continue as planned.
Symptom monitoring, when combined with testing data available from the Oregon Health Authority, will provide valuable, real-time information to help state officials identify COVID-19 hotspots to monitor the effect of reopening Oregon. COVID-19 testing for asymptomatic participants, will be temporarily delayed.
These study protocols will remain in place until new federal authorizations for home-based test kits are available.
In April 2020, Key to Oregon researchers began exploring home-based COVID-19 tests developed by commercial manufacturers under FDA Emergency Use Authorization, or EUA. EUA is an authority granted to the FDA that allows unapproved medical products to be used in an emergency to protect public health.
Shortly after the Key to Oregon’s announcement on May 1, the FDA updated its guidance for home-based COVID-19 tests. The new guidance requires third-party test kit manufacturers to obtain an EUA that specifically authorizes home-based, self-collection and shipping. Key to Oregon researchers have been in close contact with two FDA compliant test kit manufacturers. We expect to be able to offer at-home testing for study participants soon.
OHSU, the OHSU-PSU School of Public Health and the Key to Oregon study appreciate the ongoing collaboration and support of the FDA, the State of Oregon, the Oregon Health Authority, test kit manufacturers and donors as we continue to respond to the ever-evolving COVID-19 pandemic. The study team is deeply grateful to the randomly selected Oregonians across the state willing to offer their time to this study.
For more information about the Key to Oregon study, visit ohsu.edu/KeyStudy.
Additional details about the Key to Oregon study
COVID-19 testing is just one aspect of the Key to Oregon research study. Symptom monitoring is a crucial element of the study that - over time, via a phased approach - will allow researchers to understand more about how and where the virus is spreading across the state.
The below timeline outlines study phases, including where we are as of May 28, 2020:
- Enrollment (started 5/23) – the study begins consenting study participants
- Participant set-up (started 5/26)– the study team works with participants to set up their accounts, participants begin to take initial surveys, and request a thermometer, if they’d like one
- Symptom surveys (not started) – participants begin sharing information about their symptoms
- Testing symptomatic individuals (not started)
- Testing asymptomatic individuals (not started)