The first COVID-19 test kit approved for home testing

The product was developed by U.Sdiagnostic firm LabCorp, which the FDA said submitted data showing that home tests were as safe and accurate as sample collection at a doctor's office, hospital or other test site" with this approval, patients can now collect samples at home, safe and convenientDrStephen MHahn of the FDA said in a statementafter obtaining FDA approval, LabCorp also released a video and a picture explaining how to collect, manage and send samples, see the figure below:the kit is currently listed at $119, according to The CorpLab websiteUsers can use a specially designed cotton swab provided in the kit and simply walk to the nasal cavity instead of deeper nasopharynx for sample collectionSamples are then sent to the lab for testing using the included shipping package, which can produce results within one to two days of receiving the sampleLabCorp said the product will be available first to medical workers and other front-line employees, and plans to provide the tests to consumers in most states in the coming weeks, as directed by doctors01.
The FDA's opening of the "green light"the "green light" of home testing is undoubtedly a major shift in the FDA's approval of the new corona virus testa week before LabCorp's home testing kits were approved, the FDA emphasized that it had not authorized the use of any home testing or sample collection kits, noting in particular that many of the startup's similar products were not authorized, even though they had been laboratory-certified for molecular RT-PCR testing to detect COVID-19, the FDA expressed some concerns about the collection of samples at home: "The composition of the sample collection medium can be used safely in a home environment (due to the fact that certain ingredients may be toxic), appropriate shipment, and appropriate stability of the sample, taking into account the time interval between collection and testing and potential lying conditions of transport (e.g., if the specimen is sitting on a hot truck)the situation in the United States is not optimistic As of 6 p.m ET on April 21, there had been at least 820,104 new cases of coronavirus infection in the United States, including 44,228 deaths, according to the Johns Hopkins University Live Surveillance System clearly taking into account the current outbreak in the United States and under pressure to expand the scope of testing, the FDA recently updated its guidelines, noting that it is working with home test providers to determine the best way to make these tests available to the public because it believes that expanding THE availability of COVID-19 testing is valuable to public health in a safe and accurate manner FDA points out that only LabCorp's COVID-19 RT-PCR testing is currently authorized, and that the FDA still requires that any such test must have an EUA to provide services, whether or not medical professionals are authorized to conduct testing at home under the guidance of telemedicine Some laboratories use exceptions in FDA guidelines to facilitate serological testing at home, but the agency does not believe they can confirm COVID-19 cases 02.
Experts differ COVID-19 tests in the United States, which currently rely mainly on in-car testing as well as outpatient and hospital tests These tests have high entry barriers to risk profiles and symptom performance, and the management of these tests puts health care providers responsible for testing at risk of infection Home testing can improve overall detection rates while reducing the risk of front-line health care workers and better understanding the true scope and depth of the COVID-19 pandemic Experts are divided on the pattern of home-tested Medical experts say home testing can increase consumer convenience and reduce the need for people to go to medical facilities and avoid cross-infection, the New York Times reported "It's not a game-changer, but it's probably part of our response to the big and confusing (new corona) challenge to do as many tests as possible to stop COVID-19," said Dr Sheldon Campbell, associate director of the Clinical Microbiology Laboratory at Yale University School of Medicine, "Home testing will support telemedicine and help patients with difficult transportation and hard-to-reach testing however, experts have also warned that nasal swabs are less accurate than the gold-standard sample collection of coronaviruses conducted by the professional health department, which involves inserting long nasal swabs upward through the nose into the back of the throat For example, a small, peer-reviewed study from France said that last week the false negative rate of coronavirus tests with nasal swabs was higher than for longer swabs at the same time, sampling at home may also increase the time it takes people to get test results 03.
LabCorp: Announced at the same time as the approval announced a spending cut
LabCorp Corp., one of the world's independent medical laboratories giants, founded in 1971, is headquartered in Burlington, North Carolina, with more than 60,000 employees worldwide Its products, which include door-to-door testing of colorectal cancer, diabetes and heart lipid diseasethroughthroughly colorectal cancer through its Pixel line, have nearly 50 years of experience in medical testing, and this time the FDA has authorized the opening of home testing, indicating that the FDA seems more inclined to companies with long-term industry experience , based on related data, LabCorp's 2019 revenue exceeded $11.5 billion , however, it's worth noting that, on the same day that LabCorp announced that its home COVID-19 test kit was approved by the FDA, LabCorp Corp also announced that it was considering a number of spending cuts, including delays in hiring, layoffs, and more Adam Schechter, chief executive of LabCorp Corp, said LabCorp's financial position had taken a hit as it "delayed research" on drugs and treatments with customers, while the business of "monitoring patient health and diagnostic testing" had declined responding to media inquiries, LabCorp's chief communications officer, Patti Kushner, explained why the cost was reduced "We support COVID-19 testing and our commitment and ability to support related patient research consistently, and we will continue to innovate to advance testing and treatment," she said "
" Unfortunately, the COVID-19 outbreak is affecting our routine business in the form of customer deferred research and programs, and has also led to a reduction in our business of monitoring patient health and routine diagnosis "We are deciding to reduce our spending during this outbreak and are taking prudent steps to keep our employees working while ensuring the long-term growth of our business," But Kushner stressed that the company is not prepared for mass layoffs everyone is waiting for the outbreak to end, although no one knows when it will end According to the FDA's official website, so far, 43 new coronavirus testing products have been authorized by the FDA for emergency use reference link
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original title: FDA premieres "at home" new corona virus detection green light, Experts disagree.