For plasma samples in which CMV DNA is detected and between the analytical measurement range (AMR), a quantitative value (IU/mL) will be reported. In patient's where the CMV DNA is detected outside the Analytical Measurement Range (AMR), a result of <250 IU/mL or >10,000,000 IU/mL will be reported. If CMV DNA is not detected, a result of "Not detected" will be reported.
A result of "not detected" does not rule out the presence of CMV DNA or the absence of infection. False negative results may be due to the suppression of viral replication to levels below the detection threshold, or to inhibitory substances that may be present in the specimen. Inadequate specimen collection, processing and storage may invalidate test results. This test should not be used as the only criterion to form a clinical conclusion, instead, results should be correlated with other test results, patient symptoms and clinical presentation.
DNA sequence polymorphisms in CMV strains may underestimate viral levels. The presence of variations in CMV DNA sequences are monitored in the real-time PCR assay and, if detected, the sample is retested using reagents to alternate amplification targets to verify CMV detection and quantification. This assay does not genotype the virus, and consequently does not provide any information with regard to CMV drug resistance.
The performance characteristics of this test were validated by UWHC Clinical Laboratories. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test; however, FDA approval or clearance is currently not required for clinical use of this test. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. The UWHC Clinical Laboratories is authorized under Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing.