Eurofins Viracor, an infectious disease testing laboratory, has developed the test based on its FDA authorised SARS-CoV-2 RT-PCR assay
empowerDX at-home Covid-19 testing kit authorised for use in children aged three years and above. (Credit: Masum Ali from Pixabay.)
Eurofins Clinical Enterprise, doing business as empowerDX, has received the US Food and Drug Administration (FDA) Emergency Use Authorisation (EUA) for its at-home Covid-19 testing kit for use in children aged three years and above.
Owned by Eurofins Scientific, the US-based clinical diagnostics company is said to be the first company to receive EUA for an at-home PCR nasal test for young children.
It has rolled out its FDA-authorised at-home Covid test in 2020, for use in people aged 18 years and older without requiring any prescription.
The company claimed that its test kit is one of the most sensitive at-home Covid-19 tests available in the market, which enables users to precisely detect the presence of the virus, regardless of symptoms.
Eurofins Viracor, an infectious disease testing laboratory for more than 35 years, has developed the test based on its original FDA authorised SARS-CoV-2 RT-PCR assay.
Users aged 18 years and above can self-collect the sample using a painless, shallow nasal swab that comes with the empowerDX testing kit.
Adolescents aged 13 years and above can self-collect under adult supervision, while children aged three years and above are required to take the assistance of an adult for sample collection.
EmpowerDX at-home test kit includes step-by-step instructions, nasal swab, test tube and a pre-paid FedEx package for easy sample returns and is covered by most insurance carriers.
Users have to activate their kits online before taking the test, and the results will be delivered securely to a patient portal, within 24-hours from sample receipt at the company’s CLIA-certified laboratory.
The company said that its at-home testing kit has not been FDA approved, but is authorised by the FDA under the EUA.
The test has been authorised only for the home collection and maintenance of nasal swab specimens to detect nucleic acid from SARS-CoV-2, and not any other pathogens.