The rapid portable test holds the capacity to identify SARS-CoV-2 antigen in people with active infections in two to 15 minutes
Qiagen has secured FDA EUA for QIAreach SARS CoV-2 Antigen Test. (Credit: Gerd Altmann from Pixabay)
Qiagen has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its QIAreach SARS CoV-2 Antigen Test.
The rapid portable test, which can identify SARS-CoV-2 antigen in people with active infections in two to 15 minutes, has the potential to process an average of up to samples per hour.
According to the company, clinical studies demonstrated that the test has a sensitivity of at least 80% and a specificity of 98.0%.
The QIAreach SARS-CoV-2 Antigen Test is said to be the second Qiagen Covid-19 test, which uses the digital eHub and eStick system that was developed in collaboration with Australian digital diagnostics firm Ellume.
In May this year, the company secured an EUA status for its QIAreach Anti-SARS-CoV-2 Total Test, which uses the same technology and eHub.
The eHub is a portable reader with backup battery power, which can be operated remotely from main power for up to eight hours.
The QIAreach SARS-CoV-2 Antigen Test holds the capacity to analyse nasal and nasopharyngeal swab samples from up to eight symptomatic patients simultaneously.
The easy-to-use eStick uses nanoparticle fluorescent detection technology to show the SARS-CoV-2 nucleocapsid protein, an antigen present on the surface of the virus.
Qiagen immune monitoring franchise head Jenny Howard said: “Knowledge of past and present infections is key to understanding and inhibiting the spread of the disease.
“The QIAreach SARS-CoV-2 Antigen Test delivers rapid and highly accurate results and addresses the high-volume testing needs for SARS-CoV-2 antigens – and in combination with QIAreach Anti-SARS-CoV-2 Total Test allows labs to run antigen tests and antibody tests at the same time.”
QIAreach QuantiFERON-TB, a new solution under development to diagnose latent tuberculosis infection, will also use the eHub platform.