COVID-19 Response

We have developed a suite of products in response to the COVID-19 pandemic

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:

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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 above for over-the-counter home use in the U.S*. Clinically proven for use for people with and without symptoms, with accurate test results in 15 minutes.

The app will guide you through the test including an integrated information video and step-by-step instructions. The sample is analyzed and the result is displayed on your phone after 15 minutes. Results are saved within the app and can be shared via email.

The Ellume COVID-19 Home Test complies with CDC reporting requirements and automatically reports the required data to health authorities through our secure encrypted, HIPAA compliant, cloud connection.

Not available in Australia.

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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. Both tests are now available in the U.S.

The tests are run on the eHub platform, an easy-to-use and portable digital device that provides results in less than 15 minutes.

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ellume·lab COVID Antigen & Serology Tests for 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.

Two tests can be performed at the same time, with simple, animated on-screen instructions and rapid results in 15 minutes.

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.

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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.

***The ellume·lab COVID Antigen Test 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.

****QIAreach™ Anti-SARS-CoV-2 Antigen Test has not been FDA cleared or approved, but has been authorized by 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.

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