June 25, 2022

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FDA approved COVID-19 Home Test Kit

FDA approved COVID-19 Home Test Kit

FDA approved COVID-19 home test kit, results can be obtained in half an hour.  According to a report on the Stat News website, the US FDA has recently authorized an emergency home rapid COVID-19 virus test kit. This is the first test product that can self-test at home and get results within half an hour.

FDA approved COVID-19 Home Test Kit

This home test kit was developed by Lucira Health, a California-based testing company. Users use cotton swabs to collect nasal specimens, place them in a solution bottle and stir them, and then plug them into a portable device to get a positive or negative result soon. Previously, the company’s main product was a home flu test kit. After the outbreak, it began to develop new coronavirus detection products.

The technology is similar to a standard viral genetic screening test in a laboratory. At present, most rapid test products on the market detect virus antigens, not the virus itself. Therefore, this new product has a higher accuracy rate than previous fast products. The company said that its test results match the standard laboratory test at 94%.

The US FDA stated that the United States needs to expand new coronavirus testing from medical facilities and testing sites to households. Rapid testing is vital to the work of isolating infected persons and tracing contacts, but the United States has been trapped by slow testing efficiency for several months. For this reason, the US FDA has approved nearly 300 virus test products, but most of them require professionals to do nasal swab inspections and process them with high-tech laboratory equipment. Some tests allow people to collect nasal swabs or saliva samples by themselves and send them to the laboratory for examination, usually requiring a waiting time of several days.

Jeff Shuren, director of the FDA’s Equipment Center, pointed out in the statement that with his own operational test kits, more potential patients with COVID-19 pneumonia can take immediate action to protect themselves and those around them. Extending the test to the home will effectively reduce the turnaround time of samples and reduce the risk of the virus spreading to others, especially medical personnel.

Lucira expects the test cost to be US$50 and will be launched nationwide in the United States next spring. People who test positive should be quarantined and contact a doctor. People who test negative but have related symptoms should also consult a doctor. A negative result cannot completely rule out the possibility of infection.

Are people without medical training allowed to do the test? The FDA previously approved a home test kit for AIDS, which is the only home test product for infectious diseases. Even the most common over-the-counter tests, such as pregnancy test products, are subject to years of review.

The FDA stated that emergency use authorization can quickly improve product accessibility. Under normal circumstances, it is necessary to fully review the evidence of safety and effectiveness of medical products. However, in a public health emergency, if the benefits of testing exceed the risks, in order to pursue efficiency, the review standard can be appropriately lowered.