EuroImmun, Waltham, Mass, a PerkinElmer company, has received FDA emergency use authorization for its EuroRealTime SARS-CoV-2 assay.

US clinical laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity tests can immediately begin using the reverse-transcription polymerase chain reaction (RT-PCR) test to detect SARS-CoV-2, the virus that causes covid-19. The test is authorized for use with upper respiratory specimens collected from individuals suspected by their healthcare provider to have covid-19.

The assay has also received CE mark, making it available to countries in Europe.

PerkinElmer now offers three FDA-authorized tests for covid-19: the PerkinElmer coronavirus nucleic acid detection kit, the EuroImmun EuroRealTime SARS-CoV-2 assay, and the EuroImmun Anti-SARS-CoV-2 enzyme-linked immunosorbent assay (IgG).

Hamid Erfanian, EuroImmun US.

Hamid Erfanian, EuroImmun US.

“Since the onset of this pandemic, PerkinElmer has been working diligently to support laboratories across the United States and globally by offering RT-PCR and serology assays for covid-19 testing,” says Hamid Erfanian, chief executive officer of EuroImmun US. “This latest emergency use authorization further bolsters our SARS-COV-2 detection offerings. PerkinElmer’s RT-PCR and serological testing solutions will help more customers continue to battle the pandemic.”

For more information, visit EuroImmun.