Test Methodology

This test was developed and its performance characteristics determined by the University of Chicago Medical Center Clinical Microbiology Lab. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA does not require this test to go through premarket FDA review. This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity laboratory testing. This test is used for clinical purposes. It should not be regarded as investigational or research.