Qiagen to Launch Rapid Digital COVID-19 Antibody Test

Qiagen is set to launch a portable digital test to detect antibodies in people exposed to COVID-19. The Venlo, Netherlands-based company said the test provides results in about 10 minutes.

Qiagen said the new serological test has shown to have a sensitivity 100% (CI 88.43–100.00%) and specificity of 100% (CI 95.20–100.00%). The test was developed in partnership with Ellume, a digital diagnostics company.

The test is performed on the eHub, a small portable digital device. Each eHub can handle up to eight patient samples simultaneously and can perform up to 32 total tests per hour. The nanoparticle fluorescent detection technology uses serum or plasma from patient samples. The same platform is being used for QuantiFERON-TB Access, a new solution in development for diagnosis of latent tuberculosis (TB) infection in low-resource regions with a high TB disease burden.

“Increased testing is the only way to gain visibility on the magnitude of the pandemic, which will ultimately lead to helping control it,” Davide Manissero, MD, Chief Medical Officer of Qiagen said in a release. “As a trusted partner in the fight against COVID-19, Qiagen has now added the Access Anti-SARS-CoV-2 to our portfolio as a smart solution for antibody testing that provides results with confidence. This is a rugged and portable platform that requires no hardware, can process a wide range of tests, and provides fast results. We look forward to working with Ellume to discover and develop additional tests for this platform.”

The launch of the digital antibody test comes on the heels of Thermo Fisher Scientific pulling out of its $12.5 billion bid to acquire Qiagen.

If the deal closed, then Thermo Fisher Scientific would have significantly boosted its COVID-19 detection offerings. Interestingly enough the company had a set back of sorts with its COVID-19 tests.

 FDA recently warned the Waltham, MA-based company’s TaqPath test could have a risk of false results. The risks are based on two issues related to the test kit and the associated Applied Biosystems COVID-19 Interpretive Software.