Netherlands-based Qiagen has initiated the commercialisation of the portable digital QIAreach SARS-CoV-2 Antigen Test in the US that can be used by laboratories to detect active infections in two to 15 minutes.
The company plans to add a point-of-care (POC) claim and amend emergency use authorisation (EUA) later this year.
Developed in partnership with the Australian company Ellume, the test can potentially process over 30 swab samples an hour.
It provides digital test results that do not need subjective interpretation and enable antibody tests to run simultaneously with antigen tests.
The test provides a higher throughput testing for SARS-CoV-2 antigen by processing up to eight tests per hub.
Qiagen started marketing and distributing QIAreach SARS-CoV-2 Antigen Test in the US after applying for the Food and Drug Administration (FDA) EUA for symptomatic patients.
The company anticipates receiving CE-IVD registration for the EU and other markets by the end of the year.
Qiagen CEO Thierry Bernard said: “QIAreach SARS-CoV Antigen is a fast, digital, and easy to use test that makes use of sensitive nanoparticle technology from Ellume.
“In as little as two minutes, it allows objective reading of test results that provide clear qualitative interpretation.”
QIAreach SARS-CoV-2 Antigen Test has shown a sensitivity of 90% and a specificity of 100% in clinical sample testing.
The portable system has a rechargeable battery for eight hours of remote use and can connect to laboratory information management systems (LIMS) with an optional use software.
The test uses the rugged and portable eHub to evaluate eight eSticks with nasopharyngeal swab samples from symptomatic individuals at once, each test running independently of the others.
Using nanoparticle fluorescent detection technology, the eStick identifies the SARS-CoV-2 nucleocapsid protein, an antigen present on the virus’ surface.