PerkinElmer Gets FDA Emergency Use Authorization for COVID-19 Test
PerkinElmer has received an Emergency Use Authorization from the FDA for its PKamp Respiratory SARS-CoV-2 real-time polymerase chain-reaction assay to detect COVID-19 and several other respiratory infections.
The PKamp test can simultaneously detect and distinguish between COVID-19, influenza A, influenza B and respiratory syncytial virus isolated from swabs taken from the nasopharyngeal, mid-turbinate or anterior areas of the nose.
Test analysis must be performed by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 that meet requirements to perform high complexity tests.
The test has also earned a CE IVD mark certification, the Waltham, Mass.-based company said.