The Human Advantage

Test Limitations

This Cystic Fibrosis genetic testing report is intended to facilitate identification of the disease carrier status. This test should not be used for stand-alone diagnostic purposes, prenatal diagnostic, pre-implantation or population screening. This assay will not detect all of the mutations in the CFTR gene that cause cystic fibrosis or other related conditions. Therefore, the absence of a detectable mutation does not rule out the possibility that an individual is a carrier of or affected with these diseases. Test results should be interpreted in the context of clinical findings, family history, and other laboratory data. Misinterpretation of results may occur if the information provided is inaccurate or incomplete. Rare polymorphisms exist that could lead to false-negative or false-positive results. If results obtained do not match the clinical findings, additional testing should be considered. Allogeneic bone marrow transplantation will interfere with testing and should be discussed with the laboratory or the ordering physician before testing. These results are only meant to be used by a medical professional or a genetic counselor. This test was developed and its performance characteristics determined by Advanta Analytical Laboratories. It has not been cleared or approved by the FDA. The laboratory is regulated under CLIA and CAP as qualified to perform this high-complexity testing.