To access the Herald’s local coronavirus/COVID-19 coverage, click here.
COURT HOUSE – Another new in-home COVID-19 test that provides rapid results was approved by the U.S. Food and Drug Administration (FDA) Nov. 17, but a local pharmacist and the medical director of Cape Regional Medical Center’s (CRMC) urgent care facilities see “limited value” in its use.
The COVID-19 All-In-One Test Kit, manufactured by California-based Lucira Health, is a single-use test intended to detect the novel coronavirus, SARS-CoV-2, which causes COVID-19. It is the first test where one can swab, stir, and detect the virus, getting results within 30 minutes, at home.
It joins several other at-home testing kits for the virus already available, although, in most cases, a doctor’s prescription or review is required before the test is provided.
The other at-home testing kits are either done by a nasal swab or saliva sample, and results are available one to three days after the sample is received at the laboratory.
Costs for the kits range from $109-$150.
Pharmacist Scott Reef, who owns Reef Family Pharmacy, in Court House, said the tests can detect either the active infection or antibodies. He said he would want to know if he had an active infection if he had to choose between the tests.
“These tests are super sensitive,” he noted, “so you could exhibit some symptoms, and 15 days later, still test positive.
“In addition, you also need a doctor’s prescription in most cases, which defeats the purpose,” Reef added. “It’s a tough sell to buy an at-home kit because of the cost. If you go to some of the clinics, for example, the test is free.”
Currently, Reef said, they are not testing in his pharmacy. “I have gone back and forth about in-store testing,” he said. “We are short-staffed right now, and I am not sure we could handle the increase in responsibilities.”
Dr. John Ruskey, medical director of CRMC’s three urgent care facilities, doesn’t believe the test will be a “game-changer.”
“You still need a doctor’s note to get the kit,” he said. “It could help with some of the testing backlog, but the test is not an easy one to administer. It’s not easy to go up one’s nose to get a swab. Our staff has been trained and retrained to make sure they do it correctly. The number one variable in testing results is the way you do the test.
“I think today it will have limited value,” he added. “I don’t see it as a game-changer now. That may change, but not currently.”
An FDA spokesperson did not immediately respond to questions about why the test would be used instead of having a doctor administer a COVID-19 test, since the at-home test requires a doctor’s prescription and likely visit.
According to Lucira, its single-use device was developed over five years, initially as a flu test kit, that patients could eventually purchase from local drug stores. When the pandemic began early this year, Lucira redirected its efforts to COVID-19.
The test was authorized for home use with self-collected nasal swab samples in individuals age 14 and older, who are suspected of having COVID-19 by their health care provider.
It is also authorized for use in doctor’s offices, hospitals, urgent care facilities, and emergency rooms for all ages, but samples must be collected by a health care provider when the test is used for individuals younger than 14.
The test works by swirling the self-collected sample swab in a vial that is placed in the test unit. In 30 minutes or less, the results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus.
Individuals with positive results should self-isolate and seek additional care from their health care provider. Individuals who test negative and experience COVID-like symptoms should follow up with their health care provider, as negative results do not preclude an individual from SARS-CoV-2 infection, according to the FDA.
According to an FDA spokesperson, positive results are correctly identified 94.1% of the time, and negative results are correctly identified 98% of the time.
It has similar performance to other approved tests and exceeds the FDA’s performance recommendations of 80% positive and 98% negative.
It is expected to be available in the “next few months,” according to the manufacturer.
An important component to successful at-home testing is the ability to efficiently track and monitor results, according to the FDA. As noted in the emergency use authorization, prescribing health care providers are required to report all test results they receive from individuals who use the test to their relevant public health authorities per local, state, and federal requirements.
Lucira Health also developed box labeling, quick reference instructions, and health care provider instructions to assist with reporting.
While Lucira scaled up manufacturing capabilities, its COVID-19 test kit will initially be available on a limited basis in point-of-care settings and health care networks that prescribe the test for patients to use at home. Lucira is committed to making at-home testing accessible and anticipates its test will cost around $50.
By the second quarter of 2021, Lucira Health plans to amend its emergency 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.
Follow-up monitoring will be available for public health reporting, so people can get additional guidance and information, if needed.
In response to the pandemic, the county’s Department of Health partnered with CRMC and the county’s Office of Emergency Management to expand testing for six months at various locations throughout the county (https://bit.ly/3fy84o5). Testing is by appointment and can be made by calling 609-463-6581.
To contact Karen Knight, email kknight@cmcherald.com.
