Name: CMV Qualitative by PCR, Tissue
Test Name: CMV Qualitative by PCR, Tissue
Health Link Test Code: HCCMVT
LIS Test Code: CMVT
CPT Code(s): 87496
Methodology: Real-Time PCR
Detect CMV in tissue.
Days Performed: Mon-Fri.
In-Lab Turnaround Time: 2 - 3 days.
Stat In-Lab Turnaround Time: Not available stat.
Specimen: Lung, liver, kidney, esophageal, or rectal biopsies
Collection Container: UTM(Universal Transport Medium)
Obtain Universal transport medium (UTM) or M4 Culture Transport medium from UWHC Central Service. Place tissue in UTM or M4 Culture Transport medium. Do not freeze tissue in medium.
Collection Volume: 0.1 - 0.2 g
Pediatric Collection Volume: 0.1 - 0.2 g
Testing Volume: 0.1 - 0.2 g
Pediatric Testing Volume: 0.1 - 0.2 g
Transport to Laboratory within 2 hours of collection.
Interpretation Type: Expected Results
A "Not detected" result may be the result of PCR inhibitors or virus levels below the level of detection of this test and should not be interpreted as the absence of virus. Virus quantitation is not possible due to the nature of the specimen.
A "Detected" result indicates the presence of CMV DNA. 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.
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.