This test is not validated for lung tissue or biopsy specimens; it is only validated for the lower respiratory specimens indicated in Specimen Required.
Negative results do not preclude cytomegalovirus (CMV) infection and should not be used as the sole basis for treatment or other patient management decisions.
False-negative results may occur if the viral nucleic acid is present at a level below the analytical sensitivity of the assay, if the virus has genomic mutations, insertions, deletions, or rearrangements, or if the assay is performed very early in the course of illness.
The performance of this test has not been established for monitoring treatment of CMV infection.