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QIAreach™

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 QIAGEN rapid test in laboratory
ellume QIAGEN hub with laptop

QIAreach™ Antigen and Antibody Tests: Fighting the COVID-19 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 U.S. 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 U.S. FDA Emergency Use Authorization (EUA) in August 2021**.

Learn More
ellume QIAGEN QuantiFERON in use

QIAreach™ QuantiFERON®-TB: Fighting the tuberculosis epidemic

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.

The QIAreach™ QuantiFERON®-TB test for tuberculosis (TB) infection, received CE marketing in October 2021 and is now accessible in high burden, low-resource countries and decentralized settings.

ellume QIAGEN QuantiFERON in use

Features and benefits

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
*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. **QIAreach™ Anti-SARS-CoV-2 Total Test 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.
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