We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us

Download Mobile App





FDA Authorizes First COVID-19 Test for Self-Testing at Home

By HospiMedica International staff writers
Posted on 19 Nov 2020
Print article
Image: Lucira COVID-19 All-In-One Test Kit (Photo courtesy of Lucira Health, Inc.)
Image: Lucira COVID-19 All-In-One Test Kit (Photo courtesy of Lucira Health, Inc.)
The US Food and Drug Administration (FDA) has authorized the first prescription molecular diagnostic test for COVID-19 that can be performed entirely at home.

The FDA has issued an Emergency Use Authorization (EUA) to Lucira Health, Inc. (Emeryville, CA, USA) for its single-use, user-friendly COVID-19 All-In-One Test Kit that can produce a positive or negative result at home within 30 minutes. Lucira’s test kit is differentiated by its simple ‘swab, stir and detect’ design. Clinical trials showed 100% of patients were successfully able to perform the Lucira test in about two minutes. That is significantly faster than labs which currently take two to seven days to generate similarly accurate test results.

The streamlined Lucira COVID-19 All-In-One Test Kit, which fits in the palm of a hand, extracts genetic material from the virus and amplifies it. This process takes up to 30 minutes, but a positive test result can be generated in as few as 11 minutes. The kit comes with everything needed to perform a single COVID-19 test. Users open the box containing the test device, sample vial, swab and simple instructions. Two AA batteries are inserted in the device and the sample vial is placed in the test unit. Next, the user opens the test swab packet and rotates the swab in each nostril five times. The swab is then stirred in the sample vial, and then pressed down in the test unit to start the test. The “ready” light will blink until a “positive” or “negative” green light is illuminated within 30 minutes.

“There are currently two types of COVID-19 tests that detect whether a person is infected and potentially infectious,” said Lucira Health CEO Erik Engelson. “Antigen tests detect viral proteins and can provide results quickly. However, they are not diagnostically definitive and are more likely to miss an active coronavirus infection, or positive result, compared to molecular tests. Molecular tests like Lucira’s are 50 to 60 times more sensitive than antigen tests, and considered the ‘gold standard’ for determining if someone is infected.”

“Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19. A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic. 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 Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “We look forward to proactively working with test developers to support the availability of more at-home test options.”

Related Links:
Lucira Health, Inc.

Gold Member
Disposable Protective Suit For Medical Use
Disposable Protective Suit For Medical Use
Gold Member
Solid State Kv/Dose Multi-Sensor
AGMS-DM+
Silver Member
Compact 14-Day Uninterrupted Holter ECG
NR-314P
New
Vibrating Mesh Nebulizer
Aerogen Solo

Print article

Channels

Critical Care

view channel
Image: The permeable wearable electronics developed for long-term biosignal monitoring (Photo courtesy of CityUHK)

Super Permeable Wearable Electronics Enable Long-Term Biosignal Monitoring

Wearable electronics have become integral to enhancing health and fitness by offering continuous tracking of physiological signals over extended periods. This monitoring is crucial for understanding an... Read more

Surgical Techniques

view channel
Image: NTT and Olympus have begun the world\'s first joint demonstration experiment of a cloud endoscopy system (Photo courtesy of Olympus)

Cloud Endoscopy System Enables Real-Time Image Processing on the Cloud

Endoscopes, which are flexible tubes inserted into the body's natural openings for internal examination and biopsy collection, are becoming increasingly vital in medical diagnostics. Their minimal invasiveness... Read more

Patient Care

view channel
Image: The newly-launched solution can transform operating room scheduling and boost utilization rates (Photo courtesy of Fujitsu)

Surgical Capacity Optimization Solution Helps Hospitals Boost OR Utilization

An innovative solution has the capability to transform surgical capacity utilization by targeting the root cause of surgical block time inefficiencies. Fujitsu Limited’s (Tokyo, Japan) Surgical Capacity... Read more

Health IT

view channel
Image: First ever institution-specific model provides significant performance advantage over current population-derived models (Photo courtesy of Mount Sinai)

Machine Learning Model Improves Mortality Risk Prediction for Cardiac Surgery Patients

Machine learning algorithms have been deployed to create predictive models in various medical fields, with some demonstrating improved outcomes compared to their standard-of-care counterparts.... Read more

Point of Care

view channel
Image: The PATHFAST hs-cTnI-II high-sensitivity troponin assay has been developed for the PATHFAST Biomarker Analyzer (Photo courtesy of Polymedco)

POC Myocardial Infarction Test Delivers Results in 17 Minutes

Chest pain is the second leading cause of emergency department (ED) visits by adults in the United States, generating over 7 million visits annually. In the event of a suspected heart attack, physicians... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.