CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
January 2021—Fluidigm received emergency use authorization from the FDA for the Advanta Dx SARS-CoV-2 RT-PCR assay, an extraction-free, saliva-based test to detect nucleic acid from the SARS‑CoV‑2 virus. The test runs on the Fluidigm Biomark HD microfluidics platform, which can generate as many as 6,000 test results in one day.
The clinical study associated with the EUA submission demonstrated 100 percent agreement between the saliva results from the Advanta Dx SARS-CoV-2 RT-PCR assay and results from paired nasopharyngeal samples tested with authorized assays.
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