The United States Food and Drug Administrations has approved Emergency Use Authorization (EUA) for the first over the counter COVD-19 test and will soon be available for purchase. The testing kit comes with a nasal swab, a chemical solution, and a testing strip. The test also comes with a Bluetooth-enabled analyzer that is connected to a smartphone app that interpret results. Patients can conduct their own nasal swab and analyze it in under 20 minutes without needing to send it to a lab for analysis.
This is how the test works: First, the users take a sample by inserting the nasal swab into their nose. Then, they must place it in the small analyzer which transmits data to the smartphone. The app then analyzes the results and reports it in under 20 minutes to the individual and the appropriate public health authorities. Users can choose not to put their name and email address in the app, but the zip codes and date of birth is mandatory.
The test displays a 96% accuracy on subjects from 2 to 82 years old that present COVID-like symptoms. For asymptomatic subjects, it displays a 91% accuracy. This means there will still be false positives and false negatives. If an individual gets a negative result but displays symptoms, they should double check with a health professional.
The Ellume self-test is crucial in controlling the spread of COVID-19. The test provides users with real-time results and reports it to health authorities. This will allow patients to begin self-isolation immediately in the case of a positive result, limiting contact with other individuals by reducing the need to go to a health center for a test.
Out of all the home tests in the market, only the Ellume home test does not require the sample to be sent to a lab for analysis. The home test was developed by Brisbane-based digital diagnostics company Ellume. It is the first of its kind to be granted EUA and is a big step to helping combat the coronavirus pandemic. The test is expected to cost around $30. This approval will allow the test to be purchased from drugstores, pharmacies, and even online. For now, supplies of the test will be limited. Fortunately, the company expects to produce more than 3 million tests next month, shipping over 100,000 tests per day. Within the first half of 2021, they plan to produce 20 million tests for the U.S.