ellume·lab for the healthcare professionals
ellume·lab is a versatile, handheld digital device designed for healthcare professionals at the point of care. ellume·lab offers a growing range of highly accurate, rapid diagnostic tests for the detection of common infectious diseases.
ellume·lab provides practitioners with a suite of digital tools to support clinical decision-making and enhance patient engagement, on the same device. All ellume·lab digital tools offer secure, HIPAA compliant cloud connectivity for sharing results with patients or other healthcare professionals.
The COVID Antigen test (for the detection of active COVID-19 infections) is currently available*. The COVID Serology test (for the detection of total antibodies to SARS-CoV-2) is pending regulatory clearance.
Swab+drop COVID-19 Self-swab Kit
The swab+drop COVID-19 Self-Swab Kit allows for the self-collection of nasal samples to undergo testing at a laboratory. The self-swab kit will support screening at collection centres.
The Ellume swab+drop Self-Swab Kit has an entry on the Australian Register of Therapeutic Goods (ARTG). We endeavour to work with pathology laboratories to make this product available to Australian patients in the coming months.
*This product has not been FDA cleared or approved, but has been authorized by the FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, the emergency use of this product 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 authorization is revoked sooner.