WHAT YOU NEED TO KNOW:
- U.S regulators announced on Tuesday that a COVID-19 diagnostic test intended to detect the novel coronavirus can now be performed at home with results out in 30 minutes.
- The FDA approval was made to scale up testing options for the virus and mitigate virus transmission to people including health care workers.
- The single-use test kit will be provided by California company Lucira Health and is authorized for prescription use only.
The U.S. Food and Drug Administration on Tuesday granted emergency authorization for the use of the first COVID-19 test that can be performed at home and provide rapid results.
The FDA announcement comes as a move to address the public health crisis by extending testing alternatives for COVID-19 beyond health care facilities and testing laboratories. The decision was also made to lessen turnaround times and help curb the spread of the virus especially to health care workers.
“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,” said Dr. Jeff Shuren, the FDA’s devices center director, in a statement.
However, the test currently requires a prescription, thereby limiting widespread use.
The single-use test kit from California manufacturer Lucira Health uses technology resembling genetic laboratory-based tests which are the standard tool for COVID-19 screening. It allows users to collect their own nasal swab samples which are swirled in a vial and placed in the test unit. In about 30 minutes or less, positive or negative results can be read from the light display on the device.
The release further said that those who tested positive should isolate and seek medical care from their health care provider. Whereas those who received negative results yet still have COVID-like symptoms should see a doctor since negative results do not count out a COVID-19 infection.
For months, U.S. testing has been beset with slow results caused by bottlenecks at testing sites. Despite the almost 300 coronavirus tests currently authorized by the FDA, the majority of these require nasal swabs processed in lab special machines operated by health professionals to determine the results. Although some tests allow people to take their own samples at home, it is sent to a lab and takes days before results are delivered.
Lucira’s test was also authorized for use in doctor’s offices, and testing sites including hospitals and emergency rooms, only medical professionals should collect the samples and submit the results to state and federal health authorities for contact tracing, as per the company’s website.
“I think increased testing closer to patients, including in the home, is the way of the future,” said Dr. Robin Patel of the Mayo Clinic, in an interview prior to the FDA announcement, adding that steps have to be taken to ensure such tests are done safely and effectively.
Lucira did not immediately respond to a request for more details.