Name: CMV Quantitative by PCR
Test Name: CMV Quantitative by PCR
Health Link Test Code: HCCMVDNA
LIS Test Code: CMVDNA
CPT Code(s): 87497
Methodology: Real-Time PCR
Detect and quantitate CMV in blood.
Days Performed: Mon-Fri.
In-Lab Turnaround Time: 2 - 3 days.
Stat In-Lab Turnaround Time: Not available stat.
Collection Container: Lavender top
Also Acceptable: K2EDTA Plasma Preparation Tube (PPT)
Collection Volume: 6 mL
Pediatric Collection Volume: 2 mL
|Whole Blood||Not acceptable|
||Indefinitely at -70°C|
|7 days at -20°C|
Sample Analyzed: Plasma
Testing Volume: 3 mL
Pediatric Testing Volume: 1.2 mL
For optimal specimen, separate cell-free plasma from whole blood and transfer to a sterile polypropylene tube preferrably within 6 hours of collection. Freeze plasma at -60°C to -80°C (preferred). Prior to freezing, EDTA plasma may also be stored at either 2°C to 8°C or frozen at -20°C for up to 7 days.
Outreach Specimen Processing:
Transport whole blood or separated plasma (preferred) at room temperature to Laboratory using priority overnight delivery only.
Transport specimen to Laboratory immediately. If frozen, transport separated plasma on dry ice and keep frozen.
LIMIT: One specimen every 48 hours.
The reported concentration of CMV virus particles in blood may indicate viremia levels and treatment efficacy.
Interpretation Type: Expected Results
Analytical measurement range for this test is 250-10,000,000 IU/mL (2.40-7.00 log10 IU/mL) of plasma. Detection range is 50 - unlimited IU/mL of plasma.
For plasma samples in which CMV DNA is detected between the analytical measurement range (AMR), a quantitative value (IU/mL) will be reported. If 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.