The new digital test enables the detection of SARS-CoV-2 coronavirus antibodies within 10 minutes
Qiagen has secured FDA EUA for QIAreach Anti-SARS-CoV-2 Total Test. (Credit: PIRO4D from Pixabay)
Qiagen has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its fast and easy-to-use QIAreach Anti-SARS-CoV-2 Total Test.
The new digital test will allow healthcare professionals to detect SARS-CoV-2 coronavirus antibodies within 10 minutes.
Qiagen has developed the QIAreach Anti-SARS-CoV-2 Total Test by partnering with Australian digital diagnostics company Ellume.
The test is said to be the first of two Qiagen Covid-19 tests to make use of Ellume’s digital eHub and eStick system.
The digital eHub device, which allows to read individual test results, has the potential to process up to 32 tests per hour. It is also designed to run the antigen test.
According to the company, the QIAreach Anti-SARS-CoV-2 Total Test is a serological test that has demonstrated to have a sensitivity of 93.85% and a specificity of 97.83 %.
Qiagen’s technology enables to identify total antibodies (Total immunoglobulin) specific to SARS-CoV-2 immune response.
Qiagen chief medical officer Davide Manissero said: “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.
“As societies are now returning to normal daily routines, understanding the Covid-19 immunity in a population can help guide public health measures.”
The QIAreach Anti-SARS-CoV-2 Total Test is designed to produce easy-to-read results on the digital eHub platform.
According to the company, each QIAreach eHub can handle up to eight samples on eight eSticks simultaneously.
In early September 2020, Qiagen unveiled QIAreach SARS-CoV-2 Antigen Test for the detection of active SARS-CoV-2 infection. It was submitted to the FDA for an EUA.
The company also introduced the QuantiFERON SARS-CoV-2 test in November last year, to identify T-cell responses in people who have had natural infection or vaccination.