FDA approves emergency use for first at-home Covid-19 test kit

Covid-19 nasal swab test on the patient.

Lisa Maree Williams | Getty Image News | Getty Images

The US Food and Drug Administration (FDA) has previously approved emergency use for a Kovid-19 trial that can be conducted entirely at home.

The agency approved a single-use test, which provides results within 30 minutes, to be used by anyone age 14 and if their health care provider suspects they have a Kovid-19 Can.

Manufactured by Luciera Health, a privately held California-based biotech company, the kit is also eligible for use in hospitals, although patients under 14 must have a sample collected by the health care provider.

The FDA did not disclose the cost of the test. The company’s website says the test “costs less than $ 50.”

FDA Commissioner Stephen Hahn said in a press release, “While Kovid-19 clinical trials have been authorized for in-house collection, this is the first that can be completely self-administered and provide results at home. “

“This new trial option is an important clinical advancement to address the epidemic and reduce the public burden of disease transmission,” he said.

Nasal swab testing involves swapping of a patient’s self-collected sample in a vial, which is then placed in a test unit. Results appear on the light-up display of the test within 30 minutes.

The FDA stated that individuals who test positive should self-isolate and seek additional care from their health care provider. Those who test negative and experience symptoms like Kovid should also follow up with their health care provider.

Source link

Related Posts