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FDA Approves Self-Testing COVID-19 Kit for Home Use and Diagnosis – First of Its Kind

FDA Approves Self-Testing COVID-19 Kit for Home Use and Diagnosis – First of Its Kind

The US Food and Drug Administration (FDA) has approved the first self-testing COVID-19 kit for home use and diagnosis – the first of its kind. The rapid self-test for coronavirus can be carried out at home and the result obtained within 30 minutes. The kit is known as the Lucia COVID-19 All-In-One Test Kit and available by prescription.

The coronavirus self-testing kit contains a sterile swab, a sample vial, a test unit, batteries, and a plastic disposal bag. To test for COVID-19 at home, a user uses the sterile swab to collect nasal swab and then inserts the swab into the vial which is in turn put into the test unit. The unit analyzes the nasal swab and displays test results by changing the colors of the LED indicators on the unit. In a case where the potential user is not sure of how to proceed, they can read the instructions on how to use it with the prescription.

The self-testing home COVID-19 test kit works by a molecular amplification technology that analyzes the characters of the COVID-19 virus in people before providing results. It analyzes the genetic and molecular materials of coronavirus in people to whom it is applied; and once it identifies the genetic materials of the virus in any individual, it returns a positive test result.

This is the first time the FDA would be approving a self-administered COVID-19 diagnostic rapid test kit for home use, but it can also be used in a doctor’s office and in emergency rooms of hospitals. The FDA approves the kit for home-use for persons above the age of 14, but it must be administered by a health practitioner to persons below the age of 13.

“Making it possible for Americans to do their own rapid COVID-19 self-test at home by prescription is the latest addition to our constantly expanding arsenal of COVID-19 testing options,” said Health and Human Services Secretary Alex Azar. “Expanded testing, rapid testing really could be one more tool that brings us back to a life that approaches more normalcy.”

According to health authorities, the United States has recorded almost 250,000 coronavirus deaths per day since May this year in an emerging second wave of the pandemic. This development has made the health and political authorities to implement tougher measures to curb the spread of the pandemic, as well as sanctioning newer methods of self-diagnosis and rapid test kits for personal and family use.


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