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The Food and Drug Administration (FDA) on Tuesday issued emergency use authorization for the first COVID-19 self-test you can perform at home, a potentially major breakthrough to help fight the pandemic.
“Throughout this pandemic, the nation has lacked adequate COVID testing capabilities,” Dr. Russell Medford, president of the Center for Global Health Innovation and Global Health Crisis Coordination Center, told Salon. “This has hampered our efforts to diagnose, monitor public health, and reduce community risks (wearing masks, physical distancing, hand washing). This approval represents the first of what we hope will be a new class of products. widely available, fast, accurate and affordable. and easy-to-use home Covid testing, which will fill a critical testing “gap” and materially increase the country’s testing capacity. “
The test, known as the Lucira COVID-19 All-In-One Test Kit, allows users to collect nasal swab samples from their homes, swirl them around in a vial, and place them in a device. portable test. In half an hour, a light on the device will notify users if they have tested positive for SARS-CoV-2, the novel coronavirus responsible for COVID-19 infections.
“A comparable innovation would be the home pregnancy test,” wrote to Salon Dr. Deborah Doroshow, assistant professor of medicine at the Icahn School of Medicine in Mount Sinai. “The first home pregnancy test, ept (for Early Pregnancy Test) was approved by the FDA in 1976. The kit itself included a test tube, 2 droppers and a test tube scaffold with a mirror to help the user see the results. “
Because there were so many steps, “there was a lot of possibility of error” in the first home pregnancy tests, Doroshow noted. “Most doctors did not accept his results as ‘the truth’, requiring follow-up testing in their practice. The development of sticks that could be held at one end, allowing the user to avoid contact with her own urine, increased the popularity of home pregnancy. tests. “
Doroshow noted that there are “many parallels” between early home pregnancy tests and the Lucira COVID-19 test, observing that “its accuracy will certainly depend on the ability of the home user to properly collect the sample and follow the attached instructions. accuracy in a real-world setting is unknown, and clinicians may want to repeat positive tests in a healthcare setting. She also pointed out that the test required users to stick a nasal swab deep into their own nostrils, which could limit the general public’s willingness to use it.
Dr Naomi Rogers, professor of the history of medicine at Yale University, told the Salon by email that there were concerns about the effectiveness of this test, “especially since the current politicized decisions by the FDA threatened its reputation as a highly reliable regulator of things. medical. ” In contextualizing the new COVID-19 home test in the larger history of home medical testing, Rogers echoed Doroshow in highlighting the approval of the home pregnancy test as a groundbreaking test in “reproductive practice. and decision making ”. She also said that “it should be noted that [there] are no longer home tests, as with 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 the ads I’ve seen. “
She added: “Home screening for diabetes is part of diabetes management – [though] not, I think, from the initial diagnosis. “
Dr Rene Almeling, associate professor of sociology at Yale University, also told the Salon in writing that “in the past, the development of home tests for everything from pregnancy to HIV has caused calls to start. with caution. But high quality testing that can be done in the privacy of one’s own home can greatly expand access. “
Doroshow also said that caution should be exercised in approaching this particular test.
“No test is ever perfect, and this is no exception,” Doroshow explained. “First, emergency use authorization is not the same as FDA approval, nor does it mean that the product is safe and effective. Simply, an EUA means there is. a serious or life-threatening condition for which no approved or adequate alternative exists (in this case, a home testing kit) and there is reason to believe the product may be effective and the risks associated with its use most likely outweighs the benefits. “
She also pointed out that the test came with a number of caveats, including that “its ability to detect the presence of the SARS-CoV2 virus in these people is unknown”, that it can only be obtained with a prescription and that it is highly dependent on when you take it.
“We know the virus incubates for several days, so a negative test 2 days after exposure to someone with COVID-19 does not rule out the possibility of developing the disease – and having a positive test – several days. later, ”Doroshow added.
Salon has contacted the FDA for comment and has not received a response at the time of writing.
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