COVID-19 QIAreach™ Antigen and Antibody Tests
In partnership with QIAGEN®, Ellume has accelerated the development of two rapid, reliable COVID-19 tests to support the global response to the coronavirus pandemic.
The QIAreach™ Anti-SARS-CoV-2 Antigen Test detects SARS-CoV-2 antigens in people with active infections. The QIAreach™ Anti-SARS-CoV-2 Total Test*, is a high-performance serological test which detects antibodies in people who have been exposed to SARS-CoV-2.
We are bringing the next generation of Latent Tuberculosis Infection diagnostics to those who need it most.
In partnership with QIAGEN®, we are advancing the way tuberculosis is diagnosed. Combining our technology with Qiagen’s market leading test, QuantiFERON®, we are taking testing out of the laboratory and into the community.
ELLUME PANDEMIC INFLUENZA SELF-TEST
We have created a highly accurate digital test, which enables a user to detect influenza in 12 minutes. The Ellume Pandemic Influenza Self-test connects to a user’s smartphone and provides simple, step-by-step, on-screen instructions through the test’s app. The app also allows direct access to clinical advice and treatment.
We are working closely with relevant health authorities to connect into aggregated data in real-time, allowing for immediate response during pandemic outbreaks.
*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.