Cytomegalovirus DNA, Qualitative Real-Time PCR

Test Code
10601


CPT Codes
87496

Preferred Specimen
1 mL whole blood collected in an EDTA (lavender-top) tube or
1 mL plasma collected in an EDTA (lavender-top), or PPT EDTA (white-top) tube or
1 mL serum or
1 mL CSF, bronchoalveolar lavage, amniotic fluid amniotic fluid supernatant, random urine collected in a sterile leak-proof container or
0.5 mL vitreous (eye) fluid collected in a sterile leak-proof container


Minimum Volume
0.5 mL whole blood, plasma, serum, CSF, BAL, amniotic fluid, urine • 0.25 mL vitreous eye fluid • 3 cubic mm fresh tissue


Other Acceptable Specimens
3 cubic mm fresh (unfixed) tissue collected in a sterile plastic leak-proof container


Instructions

Whole blood: Collect whole blood in sterile tubes containing EDTA anticoagulant. Store refrigerated. Do not freeze.

Plasma: Collect blood in sterile tubes containing EDTA anticoagulant or in plasma preparation tubes (PPT). 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, centrifuge within 2 hours of collection and store refrigerated or frozen. It is not necessary to transfer the plasma from a PPT to aliquot tubes.

Serum: Collect in a red-top tube (no gel) or serum separator tube (SST) and store refrigerated or frozen.

CSF, amniotic fluid, urine, BAL, Vitreous (eye) fluid: Collect in a sterile, plastic, leak-proof container and store refrigerated or frozen.

Tissue: Fresh (unfixed) tissue submitted in a sterile, plastic, leak-proof 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 • Paraffin embedded (FFPE) tissue


Methodology
Real-Time Polymerase Chain Reaction

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 FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Set up: Daily; Report available: 1-3 days


Reference Range
Not detected


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.


Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
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.