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 hp
Sign In
Advertise with Us

Download Mobile App





First-Ever Single-Use, PCR Quality OTC COVID-19 At-Home Test Granted FDA EUA

By LabMedica International staff writers
Posted on 15 Apr 2021
The US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the first-ever single use, over the counter (OTC) sale of a COVID-19 test kit that delivers PCR quality molecular accuracy in 30 minutes or less at home.

Lucira Health, Inc. More...
(Emeryville, CA, USA) has received EUA from the FDA for its LUCIRA CHECK IT test kit that is now authorized and available for individuals with or without COVID-19 symptoms. This primarily US designed and manufactured product is the first FDA authorized, prescription, molecular diagnostic test for COVID-19 that can be self-administered by patients at home or used in a physician’s office. OTC clearance dramatically expands the availability of this highly accurate test.

The Lucira CHECK IT Test Kit fits in the palm of a hand, extracts genetic material from the virus and amplifies it similar to PCR lab tests. Each Lucira test kit contains everything needed to run one COVID-19 test. Users get the test device, two AA batteries, sample vial, swab and simple instructions. The batteries are inserted in the device and the sample vial is placed in the test unit. The user then opens the test swab packet and rotates the swab in each nostril five times. The swab is then stirred in the sample vial, which is then gently pressed into the test unit to start the test. The “ready” light will blink until a “positive” or “negative” green light is illuminated within 30 minutes. It can detect a positive result in as few as 11 minutes or confirm a negative result within 30 minutes.

In clinical trials, Lucira’s easy-to-use ‘swab, stir and detect’ CHECK IT test kit demonstrated that 100% of users successfully performed the test in about two minutes. Labs currently take two to 14 days to generate similarly accurate test results. Molecular tests are more sensitive than antigen tests because they amplify critical parts of the viral target. The targeted, molecular amplification that Lucira CHECK IT and PCR tests employ makes them demonstrably more sensitive and reliable than “rapid” antigen tests, which can miss active COVID-19 infections.

To support people who would like to quickly receive confirmation of their test results for work and other needs, Lucira offers a secure, text-based way for people with smartphones to receive a free LUCI Pass without downloading an app. The LUCI Pass was developed to support Lucira’s OTC test kit and is unique to Lucira. Users simply text a short code to access LUCI, and then go through a simple sequence of steps including scanning their test result to receive a LUCI Pass and verified test to their phone. Results are also transmitted to the required public health authorities.

“We worked with more than 1,000 people before starting our FDA clinical and usability studies. Our goal was to produce an easy-to-use test that provides PCR quality accuracy in a portable, intuitive, anytime, anywhere format,” said Lucira CEO Erik Engelson. “People are looking for ways to feel more certain in these uncertain times, and our Lucira CHECK IT test provides that.”

Related Links:
Lucira Health, Inc.


Gold Member
SARS-CoV-2 Reactive & Non-Reactive Controls
Qnostics SARS-CoV-2 Typing
Collection and Transport System
PurSafe Plus®
New
Clinical Chemistry System
P780
Specimen Radiography System
TrueView 200 Pro
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








Channels

Molecular Diagnostics

view channel
Image: AiPlex VAS for the MosaiQ platform is designed to help reduce time-to-diagnosis for patients with autoimmune vasculitis (Photo courtesy of AliveDx)

Novel Multiplex Assay Supports Diagnosis of Autoimmune Vasculitis

Autoimmune vasculitis and related conditions are difficult to diagnose quickly and accurately, often requiring multiple tests to confirm the presence of specific autoantibodies. Traditional methods can... Read more

Hematology

view channel
Image: New research points to protecting blood during radiation therapy (Photo courtesy of 123RF)

Pioneering Model Measures Radiation Exposure in Blood for Precise Cancer Treatments

Scientists have long focused on protecting organs near tumors during radiotherapy, but blood — a vital, circulating tissue — has largely been excluded from dose calculations. Each blood cell passing through... Read more

Immunology

view channel
Image: The test could streamline clinical decision-making by identifying ideal candidates for immunotherapy upfront (Xiao, Y. et al. Cancer Biology & Medicine July 2025, 20250038)

Blood Test Predicts Immunotherapy Efficacy in Triple-Negative Breast Cancer

Triple-negative breast cancer (TNBC) is an aggressive subtype lacking targeted therapies, making immunotherapy a promising yet unpredictable option. Current biomarkers such as PD-L1 expression or tumor... Read more

Technology

view channel
Image: The sensor can help diagnose diabetes and prediabetes on-site in a few minutes using just a breath sample (Photo courtesy of Larry Cheng/Penn State)

Graphene-Based Sensor Uses Breath Sample to Identify Diabetes and Prediabetes in Minutes

About 37 million U.S. adults live with diabetes, and one in five is unaware of their condition. Diagnosing diabetes often requires blood draws or lab visits, which are costly and inconvenient.... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.