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

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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.

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