Regulatory Statement
Vibrant testing does not demonstrate absolute positive and negative predictive values for any disease state or condition. Its clinical utility has not been fully established.Vibrant validates the accuracy and precision of the testing but not of its clinical or diagnostic value. So these tests are for wellness and informational purpose only. Vibrant is actively doing clinical research on these samples, de-identified from patients under an IRB and will make research publications towards the same as and when the clinical utility is well established.These tests have been laboratory developed and their performance characteristics determined by Vibrant America LLC, a CLIA-certified laboratory performing the test CLIA#:05D2078809. The test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). Although FDA does not currently clear or approve laboratory-developed tests in the U.S., certification of the laboratory is required under CLIA to ensure the quality and validity of the tests.The general wellness test intended uses relate to sustaining or offering general improvement to functions associated with a general state of health while making reference to diseases or conditions. Content provided for informational purposes only and should not be construed as medical advice. Content provided to help you make healthy lifestyle, dietary, and treatment choices in consultation with your healthcare provider. It is intended to be used as a tool to encourage a general state of health and well-being. Please consult with your healthcare practitioner for diagnosis and treatment considerations.
This test is not available in NY.