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).
“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.