First OTC Home Test For COVID-19 Approved By FDA

On Tuesday, the Food and Drug Administration authorized an Over-The-Counter rapid coronavirus test, which can be done entirely at home, without a prescription. Regulators also granted emergency use for a similar home test last month, but that one requires a doctor’s prescription.

In an effort to expand testing options, given the rise in cases all over the country, the FDA has now allowed the test to be sold in places like drugstores “where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA Commissioner Stephen Hahn, in a statement. FDA officials noted that Ellume’s test can deliver a small percentage of false-positive and false-negative results. People who get a negative result but have coronavirus symptoms should follow up with a health professional, the agency said.

Source: BioWorld

For months, researchers have been on the hunt for faster testing with minimum contact, in order to find out whether a person is positive for the virus. As it stands, a vast majority of tests still require a nasal swab performed by a health professional that must be processed at high-tech laboratories. This also takes more time, and hence a delay in treatment, leading to a possible further spread of the disease in the midst. As of now, about 25 tests allow people to collect their own samples at home via a nasal swab or saliva, but the only problem here is that the sample has to be sent to the laboratory.

Developed by Australian manufacturer Ellume, the initial supply of the test may be limited, but the company said it expects to produce 3 million tests next month before ramping up production over the first half of 2021. A company spokesperson said the test will be priced around $30 and be available at pharmacies and for purchase online.

Source: MobiHealthNews

Ellume’s COVID-19 Home Test includes a nasal swab, a chemical solution, and a testing strip. The test connects digitally to a smartphone app that displays the results and then helps interpret the results. Users can also connect with a health professional via the app.