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 Total Test, is a high-performance serological test which detects antibodies in people who have been exposed to SARS-CoV-2. The test received US FDA Emergency Use Authorization (EUA) in May 2021*.
The QIAreach™ Anti-SARS-CoV-2 Antigen Test detects SARS-CoV-2 antigens in people with active infections. The test received US FDA Emergency Use Authorization (EUA) in August 2021**.
Key Features
- Early positive results from 3 minutes
- Simple testing process
- Minimal training requirements
- Single patient visit
- Objective automated test result
- No device calibration or maintenance required
- No cold chain required
- No continuous power supply required
- No computer access required
Coronavirus: The Facts
Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus. COVID-19 is a respiratory illness primarily spread from person to person. COVID-19 symptoms can range from mild (or no symptoms) to severe illness. While multiple vaccines for COVID-19 are now approved, rapid diagnosis remains pivotal to minimising transmission.
*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.
**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.