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May 13, 2021

FDA grants EUA to Qiagen’s digital SARS-CoV-2 antibody test

Qiagen’s portable rapid test has received FDA EUA for Covid-19 antibody detection.

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to Qiagen’s portable, rapid QIAreach Anti-SARS-CoV-2 Total Test for Covid-19 antibody detection.

Developed in collaboration with Australian digital diagnostics firm Ellume, the serological test is based on the firm’s eHub technology and eStick system.

Each test, which detects if an individual has SARS-CoV-2 antibodies from a previous infection, delivers results in approximately ten minutes.

Users will be able to read individual test results on the digital eHub device, which can process up to 32 tests an hour, and will eventually carry out the antigen test at the same time.

Qiagen noted that the test exhibited 93.85% sensitivity and 97.83% specificity.

As compared to many standard tests that detect only selected antibodies, Qiagen’s technology identifies total antibodies, also known as total immunoglobulin, specific to the virus immune response.

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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.”

With FDA approval, the test will now be made available to healthcare specialists in the US. In March, Qiagen’s NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay also secured FDA EUA.

In another development, scientists at the NYU Grossman School of Medicine, US, have created an artificial intelligence computer programme that examines thousands of chest X-rays to identify which Covid-19 patients would develop fatal complications in four days.

In a study of 5,224 chest X-rays taken from 2,943 seriously ill Covid-19 patients, the programme showed an ability to predict complications with an accuracy of up to 80%.

Separately, Penn Medicine, US, has created an inexpensive, rapid Covid-19 diagnostic test that delivers results in four minutes with an accuracy of 90%.

Named Real-time Accurate Portable Impedimetric Detection prototype 1.0 (RAPID 1.0), the scalable test consists of an electrode that can be printed using a screen printer.

The electrode identifies virus present in nasal swab or saliva specimens and the results are read on a benchtop instrument or smartphone.

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