Phoenix-based The CORE Institute launched a rapid COVID-19 antibody testing program.
The test can detect an immune system response to COVID-19 in the blood and is administered at select practice locations in Phoenix; the group hopes to expand to other markets soon.
The test entails a finger prick blood test to check the immune system for the IgM and IgG antibodies, suggesting that the person had been affected but never showed symptoms. The test is performed on a drive-up basis and the patient remains in their vehicle until results are ready, which is typically around 15 minutes.
The CORE Institute is making the tests available to the community, first responders and other essential workers. "This may have implications in how we adjust our response as a community in our fight against the pandemic," said Vice Chair of The CORE Institute Jason Scalise, MD. "Antibody tests are critical in helping to identify who may have already had COVID-19 as well as those who may be able to donate plasma to those with more severe cases of the virus."
CEO of The CORE Institute and HOPCo David Jacofsky, MD, discusses how the practice developed the antibody testing program and the strategy for maintaining patient and staff safety during the process.
Question: What was the process for setting up the antibody testing program?
Dr. David Jacofsky: Our first step was making sure the tests we were providing were as accurate as possible. There are several antibody tests available with both varying degrees of accuracy and varying degrees of predictable availability. It was amazing to see how widely variable and effective different tests actually are when the raw data is analyzed. Our scientific team and statistician researched and evaluated testing data from around the world and chose a test that is made by an FDA approved diagnostic testing lab in California.
The next step was operationalizing this process and ensuring stringent safety protocols for our staff and our treasured patients.
Q: How will you prioritize and schedule tests?
DJ: Right now, all of those in the Phoenix area can schedule an antibody test seven days a week via our website. We are allowing only a specific number of tests to be performed per hour to make sure the process is as convenient as possible for those who register. Specifically in Arizona, Gov. Doug Ducey announced his intentions for a "testing blitz" in the coming days and we wanted to make sure we were able to be a resource during the blitz and have large numbers of tests available. We have already seen an increase in scheduled tests since that announcement and are able to perform a large number of tests per day.
We will soon be rolling this out to our partners in northern Arizona, and other states, and will be providing them with both the tests themselves, along with our turnkey IT platform for online scheduling, data management, privacy and FDA disclosure compliance, and customized clinical reporting based on the patient's test results and history. We continue to look at partner provider groups anxious to launch these programs elsewhere.
Q: What is the billing structure? Will insurance cover this or will it be cash pay?
DJ: Each test costs $95 and this is paid when the patient schedules their test via our website. Due to the details of FDA and EUA approval paths for tests, many tests are currently not covered by insurance despite being permitted to be sold and marketed by FDA-approved manufacturers. We at HOPCo felt it was important to begin making tests available as soon as possible so that our community would be able to have some peace of mind while payers determined whether these tests will be covered.
Q: What will it take to keep the practice clean and sterile while testing individuals?
DJ: Fortunately, the weather in Arizona provides us the ability to perform these tests in covered areas outside of our clinics. In order to ensure the safety of our staff and patients, these tests are administered while the patient remains in the safety of their vehicle. A simple finger prick blood draw is taken by our medical team and results are available in 10 to 15 minutes. Any staff member who has physical contact with the patient wears all required PPE during the interaction. Our proprietary website allows virtually all of the patient history, demographics and clinical information needed for interpretation for appropriate report results to be obtained online prior to arrival. This minimizes interaction and maximizes efficiency. This drive-up testing method will also be replicated with our partners in other states to ensure outdoor testing areas and clinic entrances or waiting areas remain completely separated.