The U.S. Food and Drug Administration (FDA) has officially granted an Emergency Use Authorization (EUA) for the first at-home COVID-19 test kit. The move could improve coronavirus testing for in-home care workers and their patients moving forward.
For now, health care workers and first responders who have potentially been exposed to the virus — or those who are showing symptoms — will be given first access to testing kits produced by LabCorp, a global life sciences company headquartered in Burlington, North Carolina.
Since the start of the COVID-19 emergency, many Americans have faced roadblocks in getting tested for the virus, making the exact number of confirmed cases largely unknown. The same holds true for hospitals and health care providers, including organizations that deliver care in the home setting.
“This is a great first step in providing more widespread testing to the health care community — and eventually our clients,” Emma Dickison, CEO and president of Home Helpers, told Home Health Care News. “We know, as we’ve been dealing with this pandemic, about the importance of widespread testing for our country to be able to help mitigate the virus. Without testing, it will be a challenge to get back to any kind of normalcy.”
Home Helpers is a Cincinnati-based in-home care franchise company that has over 300 locations across the U.S.
In addition to her role at Home Helpers, Dickison also serves as president of the Home Care Association of America’s (HCAOA) board of directors. HCAOA is a Washington, D.C.-based trade organization that represents nearly 3,000 home care companies.
As part of its testing process, LabCorp and its clinical laboratory network will allow users to receive a sample collection kit through the mail and send the test back to its labs for results. The test — which individuals can carry out themselves — involves collecting a nasal sample via a Q-tip-style cotton swab.
“Throughout this pandemic, we have been facilitating test development to ensure patients access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options,” FDA Commissioner Dr. Stephen Hahn said in a statement. “Specifically, for tests that include home sample collection, we worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital or other testing site.”
Overall, the FDA has authorized more than 50 diagnostic tests during the coronavirus public health emergency, working with over 350 different test developers.
While home health clinicians aren’t explicitly named in the FDA authorization or LabCorp’s plans, the availability of easy-to-use COVID-19 at-home test kits could aid providers in their efforts to keep both patients and staff safe.
More than anything, the ability to test and confirm suspected coronavirus cases among in-home clinicians and caregivers would help providers prevent further spread of the virus.
“Enabling individuals to self-administer sample collection will help reduce the risk of transmitting the virus to others and reduces the demand for personal protective equipment (PPE), as the tests do not require a clinician to perform the test collection,” a LabCorp spokesperson told HHCN in an email. “It is also important to have health care workers tested so that they can continue to help others in need as we fight the COVID-19 virus.”
In North Carolina, at least 14 cases of the coronavirus were recently linked to a Rutherford County-based home health agency.
Meanwhile, a 71-year-old home health patient in Kentucky passed away this week from COVID-19, the Lexington Herald Leader reported Wednesday. The patient was receiving in-home physical therapy services after suffering a severe stroke in December.
About six days after receiving a visit from his physical therapist, the patient’s home health company called and said the therapist had tested positive for COVID-19. The patient’s daughter and wife — both present during the home health visit — also contracted the virus.
While it wouldn’t take all risk out of the equation, more widely available testing for in-home care workers would — at the very least — help providers identify compromised front-line staff sooner.
“For clinicians, they are at greater risk for contracting the virus,” Dickison said. “I think the latest is that about 25% of those who have been diagnosed [with COVID-19] are health care professionals. This provides them an easy test to make sure that they are healthy at the time of work.”
Despite the two recent examples, there hasn’t been widely reported stories of home-based care providers spreading COVID-19. Within the long-term care space, nursing homes have largely taken center stage.
More than 4,900 nursing homes and other long-term care facilities across the United States have coronavirus cases, according to New York Times data. More than 55,000 residents and staff members at those facilities have contracted the virus — and more than 10,300 have died.
Yet even nursing homes and assisted living communities struggle with adequate testing.
“We’re hearing from our nursing homes and assisted living communities that have undertaken expanded testing that they are finding a high number of residents and staff who are positive, but without symptoms,” Mark Parkison, president and CEO of the American Health Care Association (AHCA) and the National Center for Assisted Living (NCAL), said in a statement. “Without access to more testing, long term care providers are at a severe disadvantage in identifying more of these asymptomatic residents and staff.”
Testing toward the bottom line
The availability of more in-home COVID-19 tests like the kind developed by LabCorp would also help providers seeing deceased visits and care interruptions due to the virus.
Fearing contact with the coronavirus, many home care clients and home health patients have turned down care services, refusing to allow caregivers or clinicians into their homes for safety reasons. At the same time, some visits haven’t been able to take place because caregivers worry about spreading the virus without appropriate PPE.
In a recent HCAOA survey of more than 1,200 in-home care professionals, 90% said their agencies were seeing clients cancelling visits. More than 60% said their agencies had employees calling off work.
“Being able to have the testing and PPE available gives both the client and caregiver the best possible opportunity to stay safe,” Dickison said. “Tests, clean surfaces, washing hands, hand sanitizers, masks and gloves — all of these things work together in concert.”
More than 70% of the respondents in the HCAOA survey said their agencies were facing shortages of masks and hand sanitizer.
In New York, a state that has been hit hard by the COVID-19 emergency, about half of all in-home care providers said they have experienced patients or family members refusing entry of caregivers, according to a separate Home Care Association of New York State (HCA-NYS) survey.
Home health providers’ bottom lines have especially suffered. In addition to seeing patients cancel visits, many agencies are also seeing decreased patient volume due to elective surgeries being delayed.
Some home health agencies have reported reductions in revenue of more than 25%, according to the National Association for Home Care & Hospice (NAHC).
Looking ahead, Dickison stressed the importance of building on the momentum of at-home testing kits for the virus.
“The fact that we are making progress is encouraging,” she said. “Home-based care … often gets minimized or forgotten. We are the first line of the health care continuum. We are with clients multiple days a week, and are able to identify when symptoms occur and get them the help they need quicker. Being able to test in the home would wonderful to help continue flattening the curve on acute and hospital care.”
*Editor’s note (April 29, 2020): The headline of this story was updated to clarify the fact the LabCorp test received Emergency Use Authorization (EUA) — not full approval — by the FDA.
Additional reporting by Robert Holly