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The FDA Has Authorized the First Home COVID-19 Self-Testing Kit

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Credit: Salon/Lucira Health/Getty Images

The Food and Drug Administration (FDA) issued an emergency use authorization on Tuesday for the first COVID-19 self-test that you can take at home, a potentially major breakthrough in helping fight the pandemic.

"Throughout the course of this pandemic, the nation has lacked adequate COVID testing capacity," Dr. Russell Medford, Chairman of the Center for Global Health Innovation and Global Health Crisis Coordination Center, told Salon by email. "This has hobbled our diagnostic, public health surveillance, and community risk reduction (wearing of masks, physical distancing, handwashing) efforts. This approval represents the first of what we hope will be a new class of widely-available, rapid, accurate, affordable, and easy to use, in-home Covid tests that will fill a critical 'testing gap' and add materially to the nation's testing capacity."

The test, known as the Lucira COVID-19 All-In-One Test Kit, allows users to collect nasal swab samples in their homes, swirl them in a vial, and put them in a hand-held testing device. Within half an hour, a light on the device will inform users of whether they have tested positive for SARS-CoV-2, the novel coronavirus that causes COVID-19 infections.

"A comparable innovation would be the home pregnancy test," Dr. Deborah Doroshow, an assistant professor of medicine at the Icahn School of Medicine at Mount Sinai, wrote to Salon. "The first home pregnancy test, e.p.t. (for Early Pregnancy Test) was approved by the FDA in 1976. The kit itself included a test tube, 2 droppers, and a scaffold for the test tube with a mirror to help the user see the results."

Because there were so many steps, "there was a lot of opportunity for error" in early at-home pregnancy tests, Doroshow noted. "Most physicians did not accept its results as 'truth,' requiring follow up testing in their offices. The development of sticks that can be held at one end, permitting the user to avoid contact with their own urine, increased the popularity of home pregnancy tests."

Doroshow noted that there are "many parallels" between the early at-home pregnancy tests and the Lucira COVID-19 test, observing that "its accuracy will certainly depend on the home user's ability to collect the sample correctly and follow the enclosed instructions. Its accuracy in a real-world setting remains unknown, and clinicians may want to repeat positive tests in a health care facility." She also pointed out that the test requires users to stick a nasal swab deep into their own nostrils, which could limit the broader public's willingness to use it.

Dr. Naomi Rogers, a professor of the history of medicine at Yale University, told Salon by email that there are concerns about the efficacy of this test, "especially as the FDA's current politicized decisions have threatened its reputation as an eminently reliable regulator of things medical." Contextualizing the new at-home COVID-19 test within the broader history of at-home medical testing, Rogers echoed Doroshow in pointing to the approval of the at-home pregnancy test as a revolutionary one in "reproductive practice and decision making." She also reflected that "it is noteworthy that [there] are not more at-home tests, such as for STIs. The current promotion of a colon cancer screening test (box) is interesting, clearly marketed to men, both white and African American. Less often to women, at least in ads, I have seen."

She added, "Diabetes at-home testing is part of diabetes management – [though] not, I think, of initial diagnosis."

Dr. Rene Almeling, an associate professor of sociology at Yale University, also told Salon in writing that "in the past, the development of at-home tests for everything from pregnancy to HIV provoked initial calls for caution. But high-quality tests that can be done in the privacy of one's own home can expand access dramatically."

Doroshow also said that there is cause for caution when it comes to approaching this particular test.

"No one test is ever perfect, and this is no exception," Doroshow explained. "First, an Emergency Use Authorization is not the same thing as FDA approval, nor it is saying the product is safe and effective. Simply, an EUA signifies that there is a serious or life-threatening condition for which no approved or adequate alternative exists (in this case, a home testing kit) and that there is reason to believe the product may be effective and that the risks of using it most likely outweigh the benefits."

She also pointed out that there are a number of caveats to the test, including that "its ability to detect the presence of the SARS-CoV2 virus in [asymptomatic] people is unknown," that it can only be obtained through a prescription and that it is heavily dependent on when you take it.

"We know that the virus incubates over several days, so a negative test 2 days after exposure to someone with COVID-19 does not rule out the possibility of developing the illness – and having a positive test –  several days later," Doroshow added.

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Schedule2 Oct 2023