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Bio-Rad Laboratories Gets FDA Emergency Use Authorization for ddPCR COVID-19 Assay

NEW YORK – Bio-Rad Laboratories has been granted Emergency Use Authorization from the US Food and Drug Administration for a digital PCR molecular diagnostic test for SARS-CoV-2, the virus that causes coronavirus disease COVID-19.

The 2019-nCoV CDC ddPCR Triplex Probe Assay is now authorized for use on the firm's QX200 and QXDx Droplet Digital PCR systems.

The plate-based digital PCR test can process 93 patient samples in a run without the need for calibration against standards required for traditional RT-qPCR. It is authorized to detect SARS-CoV-2 in nasopharyngeal, anterior nasal and mid-turbinate nasal swab specimens, nasopharyngeal wash or aspirate, and nasal aspirate specimens. 

The assay uses the primers and probes developed by the US Centers for Disease Control and Prevention, and is authorized for samples extracted with the ThermoFisher MagMAX Viral/Pathogen Nucleic Acid Isolation Kit or Qiagen QIAamp Viral Mini Kit.

The firm has reported that the test's limit of detection is 625 copies/ml using synthetic virus diluted in nasopharyngeal swab matrix and extracted with the two different extraction methods. 

Bio-Rad's ddPCR COVID-19 test has been evaluated in preliminary studies of patient samples in China, showing enhanced sensitivity relative to RT-qPCR.

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