According to the FDA, if you are a CLIA lab already EUA authorized to process COVID-19 diagnostic tests using one of these five authorized commercial RNA extraction chemistries (Perkin Elmer, Thermo Fisher, Roche, King Fisher, and Qiagen) you can immediately integrate saliva-based testing into your current protocol. Spectrum’s SDNA-1000 EUA-202432 means your lab does not need to submit for its own individual EUA for saliva-based testing. Validations for the FDA using Spectrum’s SDNA-1000 saliva collection system are only required should your lab wish to receive its own EUA for saliva-based testing incorporating an element not previously authorized or validated by the FDA.
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