In an effort to expand access to COVID-19 testing, the Food and Drug Administration on Tuesday gave emergency approval for the first rapid coronavirus test that can be self-administered at home. How will the test work? Who should take the test? How accurate is it? Dr. Jake Deutsch, founder and clinical director of Cure Urgent Care centers in New York City, who has tested over 5,000 patients for the virus, answers some of these questions.
JAKE DEUTSCH: It's manufactured by a company called Lucira. That's the name of the test. And the idea is that it's a test that individuals are going to be able to use at home. This FDA approval was fast tracked in order to have additional resources for people to get testing. A test is indicated for people who are 14 and older-- so essentially, adolescents to adults. And it is available only by prescription. So this is not something you're going to be able to go to the pharmacy and just pick up. It would have to be prescribed by a physician.
The idea is that you would be swabbing yourself. Or if you are testing a younger adult, the adult would be testing or having somebody with clinical experience taking the sample.
The interesting part about this is sensitivity is about 94%, which is reported from the manufacturer, versus most rapid tests are averaging about 96% sensitivity. So a 2% difference from other typical rapid tests, and certainly a long way from our PCR test, which are the gold standard at 99% sensitivity.
Understanding when this is valuable is really based on the situation. So people who have known exposure for symptoms, this is not going to be the test of choice, because the sensitivity isn't high enough. If you have a negative test, it always would have to be followed up with a PCR test. If the patient has a positive test, that's obviously much likely to be a real positive. But again, we have to correlate with PCR testing to be definitive, and certainly what the clinical picture looks like.
We need more options. This is great news that we have yet another option. That means less people going to their doctor's office, to urgent cares, to hospitals to get a test that could otherwise be screened at home. It would be useful for situations for rapid assessment, be for surgeries, perhaps for travel, or people that are in remote areas that don't have access to testing. We're looking forward to having this is one more piece in our momentum.
We need to make sure that it's affordable and make sure that it's being given to those most in need. People need to understand, it's still about protecting yourself. You could have a negative test but not be wearing a mask and expose yourself, and now that test is irrelevant. You're not going to be able to get a test today and go out to dinner tomorrow and travel in three days and assume that you haven't been exposed.
Those are the type of behaviors that people are really not connecting the dots. And we have to have a significant amount of responsibility in addition to getting those tests. So please do your part. Aside from this important technology that we're developing, we all need to continue to be very, very concerned and very, very vigilant.