FDA has granted emergency use authorization for the new Coronavirus Nucleic Acid Detection kit from PerkinElmer, Waltham, Mass. The kit is a real-time RT-PCR test using samples from oropharyngeal and nasopharyngeal swabs. Clinical laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) can immediately begin using the kit to detect SARS-CoV-2, the virus that causes covid-19. PerkinElmer’s RT-PCR test is marketed as an in vitro diagnostic device by meeting the requirements of the European In Vitro Diagnostic Directive, and is available in more than 30 countries worldwide.
“Despite the challenging environment, our employees have demonstrated unwavering commitment over the past 2 months to combat this global pandemic,” says Prahlad Singh, president and chief executive officer of PerkinElmer. “The breadth of PerkinElmer’s total workflow solution puts us in a unique position to rapidly address the needs of our clinical diagnostics customers.”
For more information, visit PerkinElmer.