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August 9, 2021

FDA grants EUA to Qiagen’s rapid SARS-CoV-2 antigen test 

The test can assess nasal and nasopharyngeal swab specimens obtained from eight symptomatic individuals at the same time.

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to Qiagen’s rapid and portable QIAreach SARS-CoV-2 Antigen Test.

Made for settings that need an increased volume of quick and precise test results, the QIAreach test can identify SARS-CoV-2 antigens in individuals with active infections in two to 15 minutes.

Developed in collaboration with Australian digital diagnostics company Ellume, the test can process nearly 30 swab samples in an hour and offers digital test results which do not need subjective interpretation.

The QIAreach antigen test utilises the company’s eHub and eStick systems, which include a portable reader with backup battery power that enables remote use for up to eight hours.

Furthermore, the test can simultaneously assess nasal and nasopharyngeal swab samples obtained from up to eight symptomatic patients, Qiagen noted.

Leveraging nanoparticle fluorescent detection technology, the eStick system can detect the SARS-CoV-2 nucleocapsid protein, which is an antigen seen on the virus surface.

In clinical studies, the test was demonstrated to have a minimum sensitivity of 80% and specificity of 98%.

Qiagen immune monitoring franchise head Jenny Howard said: “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.”

In May, Qiagen’s QIAreach Anti-SARS-CoV-2 Total Test received FDA EUA to identify previous SARS-CoV-2 infections.

Both QIAreach tests can be run concurrently on a single device to identify previous as well as active infections.

Separately, Becton, Dickinson and Company (BD) and CerTest Biotec have received CE Mark for a molecular test that can identify and differentiate between the Alpha (B.1.1.7), Beta (B.1.351) and Gamma (P.1) SARS-CoV-2 variants.

The VIASURE SARS-CoV-2 Variant Real-Time PCR Detection Kit for BD MAX can be used along with VIASURE SARS-CoV-2 (N1+N2) Real Time PCR Detection Kit for BD MAX or as a reflex test to detect variants from a positive sample.

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