LETTER OF AUTHORIZATION

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  • UltimateDX is a CLIA certified high complexity lab with expertise in research and development of many laboratory developed tests (LDTs).
  • UltimateDX Laboratories, the world leader in providing PCR and Next Generation DNA Sequencing in microbial identification, has validated a real-time Reverse Transcriptase PCR (rRT-PCR) assay for the specific detection of the SARS-CoV-2 virusUltimateDX has been validated for nasal swabs, sputum, and saliva samples for COVID-19 testing.
  • UltimateDX Laboratory COVID-19 Testing Status and Approval for Diagnostic Testing for SARS-CoV-2 using Nasal Swabs, Sputum and Saliva Samples.
  • Detection of the SARS-CoV-2 virus. The assay validation exceeds the minimum recommendations put forth by the FDA guidance policies and has been determined to be 100% specific and sensitive in vitro.
    CLICK HERE to review the UDX SARS-CoV-2      Molecular Diagnostic Validation Summary 
  • We have been validated and added to the FDA Website as a resource laboratory for COVID-19 Testing.
  • UltimateDX’s COVID-19 Rapid PCR Test has a 24-hour turn around time from time of receipt.
  • UltimateDX laboratory has been validated to offer the COVID-19 TEST utilizing nasal swabs, sputum and saliva samples.
  • UltimateDX will have the capacity to process 10,000 samples per day.