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

Coronavirus - FDA turns on the green light for the first home test kit
Image credit: Ellume Newswire

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.

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.

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.

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.