The self-collection kit serves as a minimally invasive, convenient and quick option for consumers to comfortably test at home
Eurofins has secured FDA EUA status for at-home Covid-19 nasal PCR test. (Credit: Gerd Altmann from Pixabay)
Eurofins U.S. Clinical Diagnostics has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its at-home Covid-19 nasal PCR test.
Eurofins direct-to-consumer company empowerDX distributes the self-collection kit, which serves as a minimally invasive, convenient and quick option for consumers to comfortably test at the home.
Consumers will secure the sample collection kit via FedEx following a simple online questionnaire.
The user-friendly kit comprises a small nasal swab, collection tube, easy to follow step-by-step instructions, as well as a pre-paid and pre-addressed FedEx package.
Viracor develops at-home Covid-19 nasal PCR test
Viracor, Eurofins’ infectious disease centre for excellence, has developed the at-home Covid-19 nasal PCR test based on its FDA EUA-authorised SARS-CoV-2 RT-PCR assay.
Eurofins is currently not offering the at-home Covid-19 nasal PCR test in New York, New Jersey, Rhode Island, and Maryland.
Eurofins stated that FDA has authorised the home-collection kit under an EUA only for the self-collection and maintenance of nasal swab specimens to detect nucleic acid from SARS-CoV-2 and not for any other viruses or pathogens.
In March, Eurofins U.S. Clinical Diagnostics network had launched its first real-time reverse-transcriptase polymerase chain reaction (RT-PCR) assay for SARS-CoV-2.
Eurofins already offers various assays, including pooled testing, antibody testing, wastewater, used-mask. It will also shortly launch saliva testing to efficiently detect Covid-19 disease.
The company supplied sensitive and specific, active infection and antibody assays to multiple clients across the world, including hospitals, physicians’ offices, nursing homes, government entities, sports organisations and employers.
In September, Eurofins Diatherix introduced a new Flu Plus test for the identification of SARS-CoV-2 and five additional viruses.