New York – PerkinElmer said after the close of the market on Tuesday that the US Food and Drug Administration has issued Emergency Use Authorization for the firm's coronavirus RT-PCR test.
CLIA-certified labs can immediately use the PerkinElmer New Coronavirus Nucleic Acid Detection Kit, which detects the SARS-CoV-2 coronavirus that causes COVID-19.
The assay recently received CE-IVD marking and can detect the coronavirus in oropharyngeal swab, nasopharyngeal swab, bronchoalveolar lavage, sputum, plasma, or serum samples. It detects SARS-CoV-2 ORF1a and N genes and has a limit of detection of 20 copies per mL using a 400 µL sample, the Waltham, Massachusetts-based firm said on its website.