The global COVID-19 pandemic has reinforced the critical role of rapid, accurate diagnostics. Rapid diagnostic tests help to reduce disease burden, manage outbreaks and community transmission, and reduce pressure on healthcare systems. Accessible, reliable, and fast diagnostics are integral to the COVID-19 response.
At Ellume, we are committed to developing high-quality digital diagnostics that can be relied on in a health crisis.
Leveraging our expertise in infectious disease, we have developed the following COVID-19 products:
COVID-19 Home Test for Consumers
The Ellume COVID-19 Home Test is an over-the-counter, rapid self-test which detects SARS-CoV-2 antigen. The test is suitable for ages 2+ years and will be available for non-prescription use in the U.S.*. It enables individuals, with and without symptoms, to test for COVID-19 infection in 15 minutes, anywhere.
Utilizing the dedicated App, users follow step-by-step instructions to perform the test including a self-collected mid-turbinate swab. The sample is analyzed and results are automatically transmitted to the user’s smartphone via Bluetooth®. Results can be shared with healthcare professionals to enable optimal therapy.
Through a secure, HIPAA compliant cloud connection, the Ellume COVID-19 Home Test provides real-time reporting of results and critical patient data to health authorities, employers and educators, for efficient COVID-19 mapping.
In U.S. – For use under Emergency Use Authorization (EUA) only.
Not available in Australia.
QIAreach™ COVID Antigen & Antibody Tests for the Laboratory Market
In partnership with global diagnostics company QIAGEN®, Ellume has developed two rapid COVID-19 tests: the QIAreach™ SARS-CoV-2 Antigen Test for active infections and the QIAreach™ Anti-SARS-CoV-2 Total Test** for past infections.
The tests are run on the eHub platform, an easy-to-use and portable digital device that provides results in less than 15 minutes.
ellume·lab COVID Serology & Antigen Tests for Healthcare Professionals
ellume·lab is a hand-held, versatile digital device designed for healthcare professionals at the point-of-care. The device will offer a rapid, highly accurate, fluorescent immunoassay-based COVID Serology test (for detecting recent or past infections) and a COVID Antigen test (for detecting active infections).
Two tests can be performed simultaneously, allowing clinics to increase testing throughput. Both tests are easy to use due to simple, interactive, on-screen instructions and feature results in 15 minutes. The ellume·lab COVID tests are undergoing clinical validation in a CLIA-waived setting.
In addition, the device features a broad menu of digital tools designed to support effective clinical decision making and enhance patient engagement.
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 in 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 endeavor to work with pathology laboratories to make this product available to Australian patients in the coming months.
*The Ellume COVID-19 Home Test has not been FDA cleared or approved; but has been authorized by the FDA under an emergency use authorization. This product 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 Cosmetics Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
**QIAreach Anti-SARS-CoV-2 Total testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C §263a, that meet requirements to perform moderate or high complexity tests. This test has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories; this test has been authorized only for detecting the presence of total antibodies to SARS-CoV-2, not for any other viruses or pathogens; and the emergency use of this test 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. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.