FDA approves self testing kit for covid-19 diagnosis at home

The US Food and Drug Administration(FDA) on Tuesday allowed an emergency authorization of the first covid-19 self-testing kit which can provide rapid results within 30 minutes.

In a statement on Tuesday, director of the FDA's Center for Devices and Radiological Health said that the latest development has been made with the view of "a significant step toward FDA'S nationwide response to covid-19".

The move will enhance the number of testing in a lesser amount of time amid the surge in coronavirus cases in the United States.

The new test uses self-collected nasal swab samples which is authorized for people aged 14 or above, while for people below 13 will need assistance from health care provider.

DA Commissioner Stephen Hahn outlined in a statement that while COVID-19 diagnostic tests have been authorized for at-home collection, fully self-administered and provide results at home is a first in the country.

"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 works by swirling the self-collected sample swab in a vial that is then placed in the test unit," the FDA said in a statement

"In 30 minutes or less, the results can be read directly from the test unit's light-up display that shows whether a person is positive or negative for the SARS-CoV-2," the virus that causes COVID-19, the FDA added.

It is noteworthy that rapid tests have low accuracy rate in general. Meanwhile, the FDA has not addressed the issue, however, in a letter to Lucira Health, it did mention that "it is reasonable to believe that you product may be effective in diagnosing covid-19.

Tom Bollyky, the director of the global health program, in a conversation with CNN expressed hope in the new method while outlining that it requires people be to cautious.

He said that expanded testing, rapid testing can help in bringing us back to a life that appeals more normalcy. "If we're able to identify at least on, perhaps even a daily basis, what our current viral load as and it helps us make ourselves safer and other," he added.