FDA Authorizes New Combined At-Home Test for Covi
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Posted On: 05/19/2022 11:10:14 AM
FDA Authorizes New Combined At-Home Test for Covid, Flu and RSV
The first-ever home test for people with symptoms of COVID-19, the flu, and respiratory syncytial virus (RSV) will be available without a prescription.
By Korin Miller
Published on May 18, 2022
Fact checked on May 18, 2022 by Rich Scherr, a journalist and fact-checker with more than three decades of experience.
The U.S. Food and Drug Administration (FDA) has authorized the first-ever home test for people with symptoms of COVID-19, the flu, and respiratory syncytial virus (RSV), giving users a one-stop approach to help diagnose their condition.
Consumers don't need a prescription to access the first-of-its-kind test, which is called the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test.
"While the FDA has now authorized many COVID-19 tests without a prescription, this is the first test authorized for flu and RSV, along with COVID-19, where an individual can self-identify their need for a test, order it, collect their sample and send it to the lab for testing, without consulting a healthcare professional," Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health, said in a statement.
Here's a closer look at the new test, how it works, its cost, availability, and more.
The process of purchasing, administering, and obtaining results from the new Labcorp Seasonal Respiratory Virus RT-PCR DTC Test is relatively straightforward, though slightly more time consuming than the at-home COVID-19 tests that were previously made available to the public.
The seasonal respiratory virus collection kits can be purchased online or in a store without a prescription. The kits will be available starting in early June through Labcorp's OnDemand platform.
The kit will cost $169, but there would be no upfront cost for those who have insurance and are experiencing symptoms, Labcorp publicist Jacob Rund told Health. Those who don't have insurance would be required to pay up front when ordering the kit.
Once the kit is received, patients collect a sample using a nasal swab, much like the at-home COVID tests. Samples can be self-collected by those who are 18 and older. Individuals 14 years and older can self collect samples with adult supervision, the FDA said. Anyone younger than 14 must have adult assistance to collect the sample.
The test can identify and differentiate several respiratory viruses at the same time, the FDA said, including influenza A and B, RSV, and SARS-CoV-2, the virus that causes COVID-19. Patients who test positive for any of these conditions are advised to have a follow-up with a healthcare provider.
How to Take An At-Home COVID-19 Test and What to Do If You Test Positive
Timeline for Test Results
Unlike the pre-existing at-home COVID tests, which provide results in about 15 minutes, the new seasonal respiratory virus swab must be sent to Labcorp for testing in order to get results. Results are provided to patients through an online portal.
The FDA doesn't give a timeline for delivery of results, but Labcorp says on its website that the average time for results of the similar physician administered version of the test is one to two days "from the date of the specimen pickup."
In other words, once your sample arrives at the lab, it's likely going to take another day or two to obtain your results—if the lab isn't backed up, William Schaffner, MD, an infectious disease specialist and professor at the Vanderbilt University School of Medicine, told Health.
The time delay in receiving results from the test is an issue that Dr. Schaffner and others say may ultimately impact the popularity of this new offering.
"You need that test result as quickly as possible," said Dr. Schaffner. "I can't see that this will help you very much." Patients, he said, will need to wait for the test to arrive at their home, then must obtain a sample, ship it to a lab, and wait for results. "That will take days," said Dr. Schaffner.
Other medical experts expressed similar concerns about the timeline for results, pointing out that the idea of being able to test yourself for the flu at home is great, but the reality of the test falls short of being a true game-changer.
"It's a good step forward," Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, told Health. "However, this is a test that has to be sent to a laboratory for processing and results."
"What really will be game-changing and is needed are at-home tests that give results at home for influenza, RSV, sexually transmitted infections, and other common infectious disease," said Dr. Adalja. "For high utilization or optimal utilization, a test that [provides] results in the home—like COVID and HIV tests do—is required."
More People Are Using At-Home Tests to Diagnose COVID—How Will We Know if There's Another Surge?
Impact on Treatment and Easing Case Loads For Providers
Having access to at-home tests for the flu, COVID-19, and RSV has the potential to reduce the strain on health care providers and even reduce the risk of spreading infections. Though here, as well, experts predict there may be some challenges.
"To a degree, it would decrease interactions and infected people coming into waiting rooms," Thomas Russo, MD, professor and chief of infectious disease at the University at Buffalo in New York, told Health.
"It could also lighten the queue," Dr. Russo added, noting that it would free up doctors to treat other people.
But the at-home test is not a perfect solution, Dr. Russo said. Given the long lag time between developing symptoms, receiving and taking the at-home test, and getting the results, patients may not be able to get medication in time.
"The sooner you treat with Tamiflu for the flu or Paxlovid for COVID-19, the better your results," Dr. Russo said. "The test is not going to be optimal in terms of timeliness and intervention."
Many doctors will write you a prescription for Tamiflu, for example, before your test result comes back positive, just in case, he pointed out.
That lag time could even raise the risk that patients become sicker with either illness before getting needed care, ultimately arriving at a doctor's office or hospital in worse shape—and using even more healthcare resources than if they had seen their doctor in the first place, Dr. Russo said.
The idea of an at-home test for COVID, the flu, and RSV is promising, Dr. Russo said. But to be truly effective, the test would need to provide users with at-home test results. And its price would need to be cheaper.
"This is just not optimal right now," Dr. Russo said.
The first-ever home test for people with symptoms of COVID-19, the flu, and respiratory syncytial virus (RSV) will be available without a prescription.
By Korin Miller
Published on May 18, 2022
Fact checked on May 18, 2022 by Rich Scherr, a journalist and fact-checker with more than three decades of experience.
The U.S. Food and Drug Administration (FDA) has authorized the first-ever home test for people with symptoms of COVID-19, the flu, and respiratory syncytial virus (RSV), giving users a one-stop approach to help diagnose their condition.
Consumers don't need a prescription to access the first-of-its-kind test, which is called the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test.
"While the FDA has now authorized many COVID-19 tests without a prescription, this is the first test authorized for flu and RSV, along with COVID-19, where an individual can self-identify their need for a test, order it, collect their sample and send it to the lab for testing, without consulting a healthcare professional," Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health, said in a statement.
Here's a closer look at the new test, how it works, its cost, availability, and more.
The process of purchasing, administering, and obtaining results from the new Labcorp Seasonal Respiratory Virus RT-PCR DTC Test is relatively straightforward, though slightly more time consuming than the at-home COVID-19 tests that were previously made available to the public.
The seasonal respiratory virus collection kits can be purchased online or in a store without a prescription. The kits will be available starting in early June through Labcorp's OnDemand platform.
The kit will cost $169, but there would be no upfront cost for those who have insurance and are experiencing symptoms, Labcorp publicist Jacob Rund told Health. Those who don't have insurance would be required to pay up front when ordering the kit.
Once the kit is received, patients collect a sample using a nasal swab, much like the at-home COVID tests. Samples can be self-collected by those who are 18 and older. Individuals 14 years and older can self collect samples with adult supervision, the FDA said. Anyone younger than 14 must have adult assistance to collect the sample.
The test can identify and differentiate several respiratory viruses at the same time, the FDA said, including influenza A and B, RSV, and SARS-CoV-2, the virus that causes COVID-19. Patients who test positive for any of these conditions are advised to have a follow-up with a healthcare provider.
How to Take An At-Home COVID-19 Test and What to Do If You Test Positive
Timeline for Test Results
Unlike the pre-existing at-home COVID tests, which provide results in about 15 minutes, the new seasonal respiratory virus swab must be sent to Labcorp for testing in order to get results. Results are provided to patients through an online portal.
The FDA doesn't give a timeline for delivery of results, but Labcorp says on its website that the average time for results of the similar physician administered version of the test is one to two days "from the date of the specimen pickup."
In other words, once your sample arrives at the lab, it's likely going to take another day or two to obtain your results—if the lab isn't backed up, William Schaffner, MD, an infectious disease specialist and professor at the Vanderbilt University School of Medicine, told Health.
The time delay in receiving results from the test is an issue that Dr. Schaffner and others say may ultimately impact the popularity of this new offering.
"You need that test result as quickly as possible," said Dr. Schaffner. "I can't see that this will help you very much." Patients, he said, will need to wait for the test to arrive at their home, then must obtain a sample, ship it to a lab, and wait for results. "That will take days," said Dr. Schaffner.
Other medical experts expressed similar concerns about the timeline for results, pointing out that the idea of being able to test yourself for the flu at home is great, but the reality of the test falls short of being a true game-changer.
"It's a good step forward," Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, told Health. "However, this is a test that has to be sent to a laboratory for processing and results."
"What really will be game-changing and is needed are at-home tests that give results at home for influenza, RSV, sexually transmitted infections, and other common infectious disease," said Dr. Adalja. "For high utilization or optimal utilization, a test that [provides] results in the home—like COVID and HIV tests do—is required."
More People Are Using At-Home Tests to Diagnose COVID—How Will We Know if There's Another Surge?
Impact on Treatment and Easing Case Loads For Providers
Having access to at-home tests for the flu, COVID-19, and RSV has the potential to reduce the strain on health care providers and even reduce the risk of spreading infections. Though here, as well, experts predict there may be some challenges.
"To a degree, it would decrease interactions and infected people coming into waiting rooms," Thomas Russo, MD, professor and chief of infectious disease at the University at Buffalo in New York, told Health.
"It could also lighten the queue," Dr. Russo added, noting that it would free up doctors to treat other people.
But the at-home test is not a perfect solution, Dr. Russo said. Given the long lag time between developing symptoms, receiving and taking the at-home test, and getting the results, patients may not be able to get medication in time.
"The sooner you treat with Tamiflu for the flu or Paxlovid for COVID-19, the better your results," Dr. Russo said. "The test is not going to be optimal in terms of timeliness and intervention."
Many doctors will write you a prescription for Tamiflu, for example, before your test result comes back positive, just in case, he pointed out.
That lag time could even raise the risk that patients become sicker with either illness before getting needed care, ultimately arriving at a doctor's office or hospital in worse shape—and using even more healthcare resources than if they had seen their doctor in the first place, Dr. Russo said.
The idea of an at-home test for COVID, the flu, and RSV is promising, Dr. Russo said. But to be truly effective, the test would need to provide users with at-home test results. And its price would need to be cheaper.
"This is just not optimal right now," Dr. Russo said.
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