The FDA has Issued an Emergency Use Authorization (EUA) for this New User-Friendly Test Kit; Testing at Home is Now Easier and Faster than Finding a Testing Site
Nov 5, 2021 16:45 EDT
November 5, 2021 (Newswire.com) –
iHealth Labs, Inc., a leader in the design and manufacturing of consumer-friendly, mobile personal healthcare products, announced today the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for over the counter (OTC) sale of iHealth’s COVID-19 Antigen Rapid Test. This self-test is suitable for individual or group testing anytime, anywhere, and delivers test results in 15 minutes at home. It is authorized and available for purchase at iHealthLabs.com in packages of two test kits for $13.98 – $6.99 per test.
“During COVID, how to get tested quickly has presented a dilemma for many people,” said Jack Feng, iHealth partner. “For example, if you or your child does not feel well when your family is traveling for the upcoming holidays, do you make an appointment for a drive-through PCR test? While waiting for your results, should you isolate yourself or continue your trip? A typical test for COVID-19 can take up half a day or more, making it time-consuming, inconvenient and expensive to get tested. Our COVID-19 Antigen Rapid Test is an easy, inexpensive alternative that determines whether or not an individual has the disease in just 15 minutes anywhere – thereby limiting the spread of COVID-19.”
Jack continues, “Our current production capacity is 100 million COVID-19 tests per month, with the expectation to produce 200 million tests a month starting in January 2022. At the cost of just $6.99 per test, employers and other groups can now affordably and efficiently offer free regular testing within their organization. This is even more important today given everyone, regardless of vaccination status, can become infected and spread COVID-19 today. This allows everyone to move into a new era of COVID testing and together build a public health defense line against COVID-19 as life returns to normal at work in offices, for travel, and at school.”
“With schools already back in session and the Delta variant that has been circulating persistently, the ability to affordably and quickly test at home is important for families,” Jack added. “What are families to do when there is a positive COVID test report at their children’s school? Thanks to our rapid antigen test, families can easily test over several days to ensure no one is infected. A new era of COVID testing is about to begin once we make self-test available and affordable to families. Careful monitoring of your family’s health and weekly testing are great options for parents and caregivers in preventing the spread of COVID-19.”
Each of the two single-use test kits comes with everything needed to conduct a COVID-19 test. The test uses a non-invasive swab to minimize any discomfort when collecting a sample. An iHealth COVID-19 Antigen Rapid Test app is available for iOS or Android phones. The app contains specific step-by-step video instructions to complete the test. Based on the clinical trial results, where the iHealth test was compared to an FDA-authorized molecular SARS-CoV-2 test, the iHealth test correctly identified 94.3% of positive specimens and 98.1% of negative specimens.
About the iHealth COVID-19 Antigen Rapid Test
The iHealth® COVID-19 Antigen Rapid Test is a lateral flow assay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.
This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older with symptoms of COVID-19 within the first seven days of symptom onset. This test is also authorized for non-prescription home use with adult-collected nasal swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first seven days of symptom onset.
This test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older, or adult collected anterior nasal swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.
The iHealth COVID-19 Antigen Home Test Kit has not been FDA cleared or approved. It has been authorized by the FDA under an Emergency Use Authorization. It has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 360bbb-3(b)(1), unless the declaration is terminated, or the authorization is revoked sooner.
About iHealth Labs, Inc.
iHealth is dedicated to helping people lead healthier lives. The company is a leader in designing and manufacturing consumer-friendly, mobile personal healthcare products connected through the cloud. It focuses on delivering high-quality products that are easy-to-use, making it simple for consumers to accurately measure, track, and share a full range of health vitals. By connecting the data through the cloud, consumers are able to see a more comprehensive view of their vitals, easily share data with health care professionals or caregivers, and take an active role in managing their health. All iHealth products sync directly with its free mobile app that simplifies comprehensive monitoring, viewing, storing, and sharing of health vitals. During the COVID-19 pandemic, iHealth was actively supporting the fight against the COVID-19 pandemic by being one of the leading manufacturers, shipping millions of thermometers to its customers.
Visit www.ihealthlabs.com to learn more.
Susan van Barneveld / Rita Lee
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© 2021 iHealth Lab, Inc.. All rights reserved.
Source: iHealth Labs, Inc.