This presentation will discuss the use of the FDA EUA process to implement SARS-CoV-2 assays to address the COVID-19 pandemic.  The use of a team-based approach, through an Incident Command structure, to optimally address all the operational challenges in validating, implementing and maintaining SARS-CoV-2 testing for the patient population in a large tertiary care referral center.  The presentation we review a comparison of five SARS-CoV-2 assays.   Evaluation of the changes in viral load thoughout the time course of COVID-19 infections will be reviewed, and how this related back to the five test comparison will be discussed.  The importance of the population tested (i.e. high versus low prevalence) will be reviewed, as diagnostic tests are being used as screening tests.  The presentation will review the testing of saliva as an alternate diagnostic specimen, and will explain the benefits and limitations of pool testing of diagnostic specimens.  In conclusion, the presentation will describe how testing is integrated with mitigation strategies necessary to curtail the COVID-19 pandemic.

Learning Objectives:

1. Describe the optimal uses for the various types of SARS-CoV-2 tests (i.e. antigen, antibody, & different nucleic acid amplification assays)

2. Discuss the molecular detection of SARS-CoV-2 during COVID-19 convalescence

3. Discuss the impact of utilizing a test with high (95%) specificity in a diagnostic setting versus screening setting

4. Review the benefits and limitations of testing alternate specimen types (e.g. saliva) and utilizing alternate testing strategies (e.g. pooling) for the detection of SARS-CoV-2