FDA approves QIAreach SARS CoV-2 Antigen Test

The test has the capacity to analyze nasal and nasopharyngeal swab samples from up to eight symptomatic patients simultaneously. The easy-to-use eStick uses nanoparticle fluorescent detection technology to flag the SARS-CoV-2 nucleocapsid protein, an antigen present on the surface of the virus. The device delivers negative results in 15 minutes – and in as little as two minutes in the case of a strong positive. This means one eHub can process on average about 30 tests per hour with the possibility for one user to operate more than one eHub. The QIAreach SARS-coV-2 Antigen Test and the QIAreach SARS-CoV-2 Antibody Test run on the eHub platform that Qiagen is using for QIAreach QuantiFERON-TB, a new solution still in development that will help low-resource and high-burden regions diagnose latent tuberculosis infection.

The rapid portable test can detect SARS-CoV-2 antigen in people with active infections in 2 to 15 minutes and can process an average of around 30 swab samples per hour, providing digital test results that do not require subjective interpretation. Clinical studies have shown the test to have a sensitivity of at least 80% and a specificity of 98.0%.