Cytomegalovirus DNA, Quantitative, Real-Time PCR

Test Code
10600

CPT Codes
87497

Preferred Specimen
1 mL whole blood collected in a (lavender-top) tube, or acid citrate dextrose ACD A or B (yellow-top) tube

Other Acceptable Specimens
Plasma collected in EDTA potassium PPT (white-top) tube • Serum • CSF, amniotic fluid collected in a sterile, leak-proof container

Instructions
Whole blood: Collect whole blood in sterile tubes containing EDTA or ACD as anticoagulant. Store refrigerated. Blood collected in tubes containing ACD anticoagulant will yield results approximately 15% lower when compared to EDTA tubes due to a dilution effect. Do not freeze whole blood.

Plasma: Collect blood in sterile tubes containing EDTA or ACD as anticoagulant or in plasma preparation tubes (PPTs). Store collected whole blood at room temperature and separate plasma from cells within 2 hours of collection. Transfer plasma to sterile, plastic, screw-cap tubes and store refrigerated or frozen. If blood is collected in a PPT tube, centrifuge within 2 hours of collection and store refrigerated or frozen. It is not necessary to transfer the plasma from a PPT tube to aliquot tubes. Blood collected in tubes containing ACD anticoagulant will yield results approximately 15% lower when compared to EDTA tubes due to a dilution effect.

Serum: Collect in a red top tube (no gel) or serum separator tube.

CSF or amniotic fluid: Collect in a sterile container and store refrigerated or frozen.

Transport Temperature
Refrigerated (cold packs)

Specimen Stability
Whole blood
Room temperature: 48 hours
Refrigerated: 8 days
Frozen: Unacceptable

All other sample types
Room temperature: 48 hours
Refrigerated: 8 days
Frozen: 30 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Heparinized specimens • Unspun PPT tube

Methodology
Real-Time Polymerase Chain Reaction (PCR)

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Set up: Daily; Report available: 1 day

Reference Range
CMV DNA, QN PCR Not Detected IU/mL
CMV DNA, QN PCR Not Detected Log IU/mL


Clinical Significance
In patients who are immunocompromised, CMV may cause disseminated, severe disease. CMV is also the most common cause of congenital viral infection in humans. Quantitative PCR methods may be useful in monitoring CMV replication in immunosuppressed patients or in determining the viral load of CMV in amniotic fluid. This is a quantitative molecular test, with a linear range of 200-2,000,000 IU/mL.

Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Dr
Chantilly, VA 20153



The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.