Q&A: Are home tests part of the solution to the coronavirus testing crisis?

As the country grapples with severely limited COVID-19 testing abilities, several organizations and start-ups have created their own at-home kits — only to have those efforts quickly rebuked by the FDA late last week.

While the FDA hasn’t authorized any home tests for purchase, the idea of putting the swabs in the hands of Americans is still gaining traction. The city of Seattle announced a new coronavirus monitoring program using home tests this week. And on Monday, the Trump administration announced “self swabs” are coming soon.

To get a better sense of the rapidly evolving home testing market and what reporters should know, I interviewed Dr. Shantanu Nundy, the chief medical officer of Seattle-based Accolade, a health benefits company, who published a recent JAMA article with Dr. Kavita K. Patel on at-home testing for COVID-19. Below is our conversation, edited for clarity and length.

Q: What is the COVID-19 testing landscape like?

A: The No. 1 issue around the country is the lack of access to testing. And where it is available, there is lots of confusion. Does my area have drive-thru testing? Do I need to contact the public health department? The at-home test is relatively straightforward with a nasal swab. As a clinician, an idea that struck me: Could this be an opportunity?

Q: What is the point of at-home testing?

A: The major challenge for us to address and mitigate COVID-19 is the lack of access to testing. If you could enable this, you could test a lot of people who are at low risk for complications. You could go from being assessed at home, to self-quarantine and self-management for positive results. We think that’s a better experience for individuals. You aren’t sitting in a crowded waiting room, potentially infecting others.

There are also folks who live in rural areas and folks who don’t have cars for drive-thru testing. In-person testing takes capacity because you need health professionals standing there. That’s someone who could be serving patients with more acute illness. We think that could have a huge impact across the health system. Getting people tested is imperative and at-home testing is a way to not overburden health care centers.

Q: What do at-home tests actually test for?

A: This is PCR based, which means it detects the actual presence of the virus in the body right now. There has been some talk of an antibody test, but the standard of care test in the ER or clinic is the RNA-based nasal swab test.

Q: How does it work?

A: Per the latest CDC guidelines, people need to be evaluated by a physician, which can be done via telehealth. You need a supplier. And, you need lab capacity to run the analysis. Efforts are focusing on each of those three pieces, and how we can stitch them together.

Q: What would the cost be and how does that compare to testing in emergency departments and other places? (STAT reported last week that the tests would cost from $150 to $200.)

A: For patients, the hope is that the test would involve a nominal copay or no copay. In our paper, we didn’t do an economic analysis. But, if you take the first part (physician evaluation), prior studies have found telemedicine is more cost effective because you don’t have the clinic overhead to manage and support. These visits also tend to be shorter.

Q: What are the policy barriers to in-home testing? Are there regulatory and reimbursement restrictions that could interfere?

A: The primary barrier for at-home testing kits is FDA approval, which we don’t have yet.

Part of President Trump’s plan is to remove those telehealth barriers. We’re starting to see this happening. Blue Cross Blue Shield of North Carolina recently announced telemedicine parity, meaning they are paying for telemedicine visits at the same cost as in-person visits.

Q: How accurate is the at-home test?

A: Under the best conditions, the sensitivity (how well a test can correctly identify someone with the disease) would be essentially equivalent to what?

That said, there is operator dependency: How well you, as a patient, can do the swab. It’s really important to think about who should do self-testing. Some people will be unwilling and some are physically unable. But, in a state of emergency, let’s put that in the hands of the doctors and patients to make that decision together.

The accuracy of self-testing was looked at in another study on influenza. They found a sensitivity of 87% and specificity (which measures a test’s ability to rule out people who don’t have the disease) of 99% compared to professionally collected samples. That means there are going to be cases with a false negative. This underscores the importance of identifying the right patients for at-home testing.

Q: How hard are such tests to do on your own?

A: It’s exactly the same as the swab for influenza. There’s certainly a technique, which can be very quickly learned. One study we referenced looked at this: professional versus self-collected samples. Ninety percent of people found it to be easy. The majority preferred self-testing. That makes sense. If you're doing it yourself, you can time it when you want — you have a sense of your own body.

Q: How close is this to happening?

A: Once FDA approval is in place for at-home testing, it would take days to weeks, not weeks to months, to launch.

Q: Will results be available online and help feed a coordinated response?

A: Absolutely. People would be able to access through a mobile platform or portal. In addition, reporting to the CDC and public labs is critical.

Q: Are the companies rushing this to market in competition?

A: The level of collaboration happening is amazing. We, in the medical community, are all in this moment for the right reasons. There’s no competition to be the first one per se. We want to help as many people as we can.

Q: What else should health journalists have on their radar?

A: Innovations are happening. What did it take to create a drive-through testing in less than one week in Baltimore? Look at how UCSF is creating outdoor tents or how hospitals are reusing personal protective equipment (PPE). It’s complex and frustrating that there’s not a single answer for the country. On the other hand, you’re seeing grit and creativity on the ground. There is a whole thread of innovation happening. There are a lot of best practices we can learn from.