FDA Authorizes First COVID-19 Self Test Kit

SILVER SPRING, MD (WBAP/KLIF) – American citizens will soon have access to a COVID-19 test kit that can be done at home.

The U.S. Food and Drug Administration issued an emergency use authorization Wednesday for the first diagnostic test kit of its kind that will provide rapid results in about thirty minutes.

According to the FDA, the Lucira COVID-19 All-In-One Test is a molecular single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19.

FDA Commissioner Dr. Stephen Hahn said the kit is an example of the department’s speediness in responding the pandemic.

“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home.This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” he said.

The test is available by prescription, uses self-collected nasal swab samples and is authorized for people age 14 and older with COVID-19 symptoms and for people 13 and under when collected by a health care provider.

Anyone who tests positive is encouraged to either self isolate or seek additional care from their health care provider.

The FDA said those who tests negative but is experiencing COVID-like symptoms should follow up with their doctor to be certain.

Lucira Health, the test manufacturer, has also developed box labeling, quick reference instructions and health care provider instructions to assist with reporting.