Skip to main content
Premium Trial:

Request an Annual Quote

Qiagen SARS-CoV-2 Serological Test Gets FDA Emergency Use Authorization

NEW YORK – Qiagen said after the close of the market on Wednesday that it has received Emergency Use Authorization from the US Food and Drug Administration for the QiaReach Anti-SARS-CoV-2 Total Test to identify whether a person carries antibodies to SARS-CoV-2 from a prior infection.

The test, which detects total antibodies specific to a SARS-CoV-2 immune response, takes about 10 minutes to perform and is read on a digital eHub device that can process up to 32 tests per hour. Qiagen said the assay has demonstrated a sensitivity of about 93.9 percent and a specificity of about 97.8 percent.

Qiagen developed the test in partnership with Australian diagnostics firm Ellume, and it is the first of two assays that will run on Ellume's digital eHub and eStick system — the other is the QiaReach SARS-CoV-2 Antigen Test to detect active SARS-CoV-2 infection, which Qiagen has submitted to the FDA for EUA.

"Serological testing for antibodies is central to identifying people who have been recently infected by the virus or have been infected in the recent past, especially those who did not show any symptoms and therefore might not know of an infection," Davide Manissero, chief medical officer at Qiagen, said in a statement. "As societies are now returning to normal daily routines, understanding the COVID-19 immunity in a population can help guide public health measures."

Qiagen is also using the same Ellume platform to develop its QiaReach QuantiFeron-TB test for identifying latent tuberculosis infections in resource-poor regions.

In November, Qiagen also launched the QuantiFeron SARS-CoV-2 test, which can detect T-cell responses in previously infected or vaccinated individuals, for research use only.