Coronavirus – FDA turns on the “green light” for the first home test kit

Fully At-Home Diagnostic Test for coronavirus will be available at pharmacies without a prescription and will give results in 20 minutes

The U.S. Food and Drug Administration (FDA) has approved the first coronavirus home test that does not require a doctor’s prescription.

The test kit, made by the Australian company Ellume, includes a self-collected mid-turbinate nasal swab and analyzer, which connects to users’ smartphones via an application to present the results.

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The test can provide results within 20 minutes.

The release of this Home Diagnostic Test represents another important step in the efforts to expand test options.

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FDA approval allows the sale of the test to places like pharmacies where a patient can buy it Over-the-Counter, can perform the test by his own and get the results in just 20 minutes.

The Ellume Coronavirus Home Diagnostic Test looks for viral proteins derived from COVID-19, a method that differs from the standard approach of other tests that look for the genetic material of the virus.

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FDA officials noted that the Ellume test can yield a small percentage of false-positive and false-negative results.

The kit includes a nasal swab, a chemical solution and a test strip.

A spokesman for the Australian company said the test would cost about $ 30 and be available Over-the-Counter in pharmacies and online.