PerkinElmer new coronavirus detection kit authorized under EUA
March 27, 2020
PerkinElmer announced that its nucleic acid detection kit for detecting SARS-CoV-2, the virus that causes COVID-19, has received emergency use authorization (EUA) approval from the Food and Drug Administration (FDA).
The detection kit is test is a real-time RT-PCR test intended for the qualitative detection of nucleic acid (NA) from SARS-CoV-2 in human oropharyngeal and nasopharyngeal swab samples. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 to perform high complexity tests, or by similarly qualified non-U.S. laboratories.
