Audere Receives EUA for HealthPulse@home COVID-19 Specimen Collection Test Kit
By Sam Brusco, Associate Editor | 12.07.21
CLIA-certified labs using HealthPulse@home authorized labeling instructions can offer new kits under Audere's EUA.
Digital health nonprofit Audere earned an Emergency Use Authorization (EUA) for the HealthPulse@home COVID-19 specimen collection test kit. The kit lets CLIA-certified labs bring their own self-collection COVID-19 specimen kits to market without needing to obtain their own EUA.
HealthPulse@home’s instructions provide for custom branding, registration, and accessioning processes what require no additional usability studies. Audere also offers recommended vendors and guidance for kit packaging, ordering, and accessioning. Organizations can then offer test kits for nasal swab self-collection that is either unsupervised or administered by a caregiver.
“Despite progress made over the past two years, COVID-19 testing remains a pain point in the United States,” Paul Isabelli, Audere’s COO told the press. “With breakthrough cases and testing mandates for unvaccinated individuals, there is a continued need for a broad set of accessible testing options. HealthPulse@home aims to eliminate many of the barriers—time, cost, and effort—that currently prevent or delay laboratories from offering their own authorized self-collection kits. Through Audere and its partnerships with organizations like LumiraDx and Previon, we look to further democratize the availability of testing.”
HealthPulse@home is currently certified for use with LumiraDx’s SARS-CoV-2 RNA STAR Complete test assay. HealthPulse@home kits must be prescribed by a healthcare provider based on clinical assessment or recommended by a public health agency.
HealthPulse@home’s instructions provide for custom branding, registration, and accessioning processes what require no additional usability studies. Audere also offers recommended vendors and guidance for kit packaging, ordering, and accessioning. Organizations can then offer test kits for nasal swab self-collection that is either unsupervised or administered by a caregiver.
“Despite progress made over the past two years, COVID-19 testing remains a pain point in the United States,” Paul Isabelli, Audere’s COO told the press. “With breakthrough cases and testing mandates for unvaccinated individuals, there is a continued need for a broad set of accessible testing options. HealthPulse@home aims to eliminate many of the barriers—time, cost, and effort—that currently prevent or delay laboratories from offering their own authorized self-collection kits. Through Audere and its partnerships with organizations like LumiraDx and Previon, we look to further democratize the availability of testing.”
HealthPulse@home is currently certified for use with LumiraDx’s SARS-CoV-2 RNA STAR Complete test assay. HealthPulse@home kits must be prescribed by a healthcare provider based on clinical assessment or recommended by a public health agency.
