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Cytomegalovirus DNA, Quantitative PCR

Item Value
Test Update Information On 9/18/13, UCSF will change in the test method for cytomegalovirus (CMV) PCR due to discontinuation of the prior assay reagents.

While the two assays are similar, there are some differences providers should note:

1) The results will be listed in International Units per milliliter (IU/mL), which is similar in clinical interpretation to the previously reported units of copies/mL.

2) The lower limit for quantification will be 137 IU/mL rather than 1000 copies/mL. The new assay has a slightly improved limit of detection compared to the previous assay.

3) There is a bias between the test methods, with results by the new method on average 0.91 log IU/mL lower than the previous method. Contact the Microbiology Laboratory (353-1268) to discuss re-establishing baseline CMV titers in patients with longstanding CMV infection.

Treatment of CMV infection should take into account the clinical presentation as well as the change in level of CMV DNA and not just the absolute level of DNA.
Approval req'd? No
Available Stat? No, however, if the patient needs the result rapidly, contact the Virology lab at 415-353-4730 to make sure the sample is included in the next available run.
Test code CMVQT
Test group CMV
Performed by Microbiology
In House Availability Test performed Monday - Friday day shift only
Method Quantitative Real time PCR
Collection Instructions Do not draw from heparin containing lines.

Note: If the patient needs the result rapidly, contact the Virology lab at 415-353-4730 to make sure the sample is included in the next available run.
Container type Lavender top
Amount to Collect 3 mL blood
Sample type EDTA Plasma
Preferred volume 1.5 mL plasma
Min. Volume 1 mL plasma IMPORTANT: for samples between 0.5 and 1.0 mL forward sample to Microbiology for them to detrmine if it can be tested.
UCSF Rejection Criteria Heparinized, grossly hemolyzed samples or repeat sample from a patient within 7 days.
Processing notes Separate plasma from cells and freeze at -70C within 6 hours of collection.
Units IU/mL
Normal range Not detected
Synonyms CMV; PCR; CID; CMV inclusion disease
Stability Room temperature 6 hours for whole blood, frozen at -70C indefinite.
Turn around times Turnaround time 1-4 days
Additional information This assay uses real-time PCR methodology to amplify a segment of the DNA polymerase (UL54) gene, and is capable of accurate quantification from 137 IU/mL to 9.10 x 10e8 IU/mL. Samples with DNA detected below the linear range will be reported as "Detected, < 137 IU/mL". Change in virus DNA level over time is a better indicator of clinical significance than absolute copy number.

The assay can reliably detect CMV DNA down to a lower limit of approximately 91 IU/mL.

This assay is most useful in monitoring patients at risk for development of CMV disease with end-organ manifestations (pneumonia, colitis, esophagitis, nephritis, chorioretinitis, encephalitis, polyradiculopathy, adrenalitis, hepatitis) or dissemination. Immunocompromised patients, including solid organ and hematopoietic stem cell transplant recipients and AIDS patients are at higher risk for clinical disease.

Changes in CMV viremia often parallel or precede end-organ clinical manifestations and can also be used to monitor treatment efficacy. Because different test methods can yield varying results, we recommend utilizing the same laboratory methodology to compare values.
CPT coding 87497
LOINC code 33006-8
LDT or Mod FDA? No
Last Updated 9/30/2013 11:37:02 AM
Entry Number 1210
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