The FDA has issued an emergency use authorization to a prescription-based at-home COVID-19 test that provides results in less than 30 minutes. It is the first test of this kind to become available for COVID-19. The only other infectious disease that has an FDA-approved at-home diagnostic test is HIV.
The single-use test will be available by prescription for at-home use or in health care settings. All the user has to do is rub a swab in their nose five times, stir it in a vial, and then press it in the machine to start the test. The “ready” light will blink until a “positive” or “negative” green light illuminates within 30 minutes.
Similar to the most common type of COVID-19 test, polymerase chain reaction (PCR) tests, this at-home covid-19 test is a molecular test that amplifies genetic material to look for the virus, explains Andrew T. Chan, MD, MPH, a professor of medicine at Harvard Medical School and Massachusetts General Hospital
“It’s called loop-mediated isothermal amplification,” says Dr. Chan, who is conducting a COVID-19 study anyone can join on their phones. “It is similar to PCR. It’s faster and less technically challenging to do, but isn’t, unfortunately, as accurate as PCR technology.” Unlike a PCR test, loop-mediated tests run at a constant temperature, allowing much quicker results and less sophisticated machinery. “It’s not as sensitive or accurate as the PCR swab, but it’s better probably than antigen testing.”
The kit has been in development for over five years, initially intended to be used as a flu test. The FDA’s authorization clears it for individuals 14 and over who have COVID-19 symptoms. Those under 14 must have the test administered by a health care practitioner. It is expected to be available nation-wide as soon as early Spring 2021 and available for $50. Lucria also has plans to amend its emergency use authorization or file a new one so “people who think they’re infected with COVID-19 can communicate with a medical professional online through a dedicated website to arrange a prescription and overnight delivery of the test kit, if approved,” reads the press release.
As cases rise around the country and barriers to testing continue to persist, having an at-home test widely available would be a game-changer, says Brian Labus, PhD, MPH, an infectious disease epidemiologist and public health professor at the University of Nevada, Las Vegas.
“It could be useful in any place where access to healthcare is an issue, especially rural areas of the country where the closest doctor or testing center may be a long drive away,” says Dr. Labus. “And then the doctor has to then send that off to a laboratory that may be several hours away.”
However, at-home COVID-19 testing also has its downsides.
“Anytime you have somebody do a test at home, we’ll lose control over the testing environment and the process. So if people aren’t using that test properly, and they’re obviously not being trained to do a bunch of those tests, then sometimes the sensitivity of those tests will suffer,” says Dr. Labus. “The other piece that I’m concerned about from the public health side is disease reporting. Even though it’s done under a clinician’s order, if I get that test at home and I don’t tell the doctor what the result is, nobody ever reports it to the health department and contact tracing never happens then.”
Even if this test becomes as widespread as the company projects, Dr. Chan says to be cautious and not think of it as a cure-all.
“There still is a need to make sure that people maintain caution with regard to large gatherings, and masks, et cetera,” says Dr. Chan. “A negative test doesn’t necessarily mean that you have a free license to do whatever you want because there is always a possibility that the test gives a false negative or that you still may have very low levels of the virus and may end up having the ability to pass the virus along in the days following the test. It should be viewed as an important addition to our fighting of COVID-19. It’s not a complete solution.”
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