FDA Approves 1st COVID-19 Rapid Test Kit That Gives Results at Home in 30 Minutes

the 30 minutes test allows users to test at home but it remains to be seen in view of Israeli-Indian test device that does the same in 30 seconds

As US Coronavirus cases continue to rise in the US, some states have started issuing new mask mandate and other social restrictions, and meanwhile, the Food and Drug Administration (FDA) granted the emergency use of the first rapid Coronavirus test that can be performed even at home instantly.

The announcement represents an important step in efforts to expand testing options beyond the healthcare facilities. But the 30-minute test kit from Lucira Health, a California manufacturer, will require a prescription.

How Does It work?

The 30 minutes test allows users to swab themselves to collect a nasal sample. The collected samples need to put in a vial that plugs into a portable device that interprets the results and shows whether the person tested positive or negative for COVID-19.

As of now, the US federal agency has authorized almost 300 tests for Coronavirus. Most of those include nasal swab tests performed by healthcare experts and for the results, the samples need to go to laboratories. Healthcare workers urged for an option that will allow people to conduct tests at home.

Dr. Jeff Shuren, director of the FDA’s devices center, said in a statement, “Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them.”

FDA Commissioner Stephen M. Hahn said while the usual diagnostic tests have been authorized for at-home collection, the 30 minutes test is the first that can fully self-administrated 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 added. The Lucira’s test was also authorized for use in doctor’s offices and testing sites.

There was only one time when the FDA approved one home test for infectious disease, and it was an HIV test. The agency authorized the new COVID-19 test using their emergency powers to quickly speed up the availability of experimental products amid a global pandemic. Usually, before providing approval to a new test, the FDA requires evidence of safety and effectiveness. But when the country is currently under massive healthcare threat, the agency chose to lower those standards.

“We look forward to proactively working with test developers to support the availability of more at-home test options,” said Jeff Shuren, director of FDA’s Center for Devices and Radiological Health. However, the news release by FDA did not disclose the details of the accuracy of the study results.

30 Second Test Kit

However, Indian and Israeli researchers jointly developed a 30 second test kit which is being calibrated by the Israel team. Once the calibration is completed, an announcement will be made and mass production will begin.

To develop the test kit, the researchers focused on four technologies; sound waves, breathalyzers based on terahertz waves, isothermic identification and checking polyamino acids. This unique and affordable technology is expected to help the world to identify Coronavirus patients faster as the system only requires a person to blow into a tube and within less than a minute the result will be out. The results can be delivered locally without using logistics and there will be no need to send the samples to labs and wait for a few days for the report.