Covid-19 nasal swab test administered on patient.
- The U.S. Food and Drug Administration (FDA) has approved emergency use for the first Covid-19 test that can be conducted entirely at home.
- The nasal swab test, which is eligible for use by patients aged 14 and over suspected of having the disease, can provide results within 30 minutes.
- The test created by California-based Lucira Health received emergency use authorization late Tuesday.
The U.S. Food and Drug Administration (FDA) has approved emergency use for the first Covid-19 test that can be conducted entirely at home.
The agency cleared the single-use test, which provides results within 30 minutes, for use by anyone aged 14 and over if their health-care provider suspects they may have Covid-19.
Produced by a privately held, California-based biotech company, Lucira Health, the kit is also eligible for use in hospitals, though patients under 14 must have their sample collected by a health-care provider.
The FDA did not reveal the price of the test. The company's website says the test is "intended to cost less than $50."
"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," FDA Commissioner Stephen Hahn said in a press release.
"This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission," he added.
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The nasal swab test involves swirling a patient's self-collected sample swab in a vial, which is then placed in a test unit. Results are then made visible on the test's light-up display within 30 minutes.
The FDA noted that individuals who test positive should self-isolate and seek additional care from their health-care provider. Those who test negative and experience Covid-like symptoms should also follow up with their health-care provider, it added.
