iHealth Statement on the COVID-19 Omicron Variant and Its At-Home Test Kit's Effectiveness
"iHealth has been continuously monitoring the COVID-19 variants so the iHealth COVID-19 Antigen Rapid Test is ready to address any significant changes in the epidemic," Jack Feng, iHealth Partner stated. "We are confident that our rapid antigen test continues to detect COVID-19 infection, including infection with the Omicron variant."
Mr. Feng continued, "Our research team has conducted an analysis based on available literature and a bioinformatics comparison. We found that the new Omicron variant strain B.1.1.529 has about 50 mutations, with 32 of them in the Spike protein. Most of the antigen detection kit products, including our test, are used to detect Nucleocapsid protein. According to the comparative analysis of bioinformatics, we are very confident that the Omicron variant is detectable by our antigen rapid test. We are also actively looking for real-world samples to conduct experiments and to further verify the effectiveness of the product in detecting this virus strain."
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 7 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 7 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.