Cytomegalovirus DNA Detection and Quantitation by PCR

Cleveland HeartLab C, Test

NEW YORK DOH APPROVED: NO
CPT Code: 87497
Order Code: C2562
ABN Requirement: No
Synonyms: CMV PCR
Specimen: EDTA Plasma
Volume:  2.0 mL
Minimum Volume:  1.0 mL
Container: EDTA (Lavender Top) tube, EDTA (Pink Top) tube

Collection:

  1. Draw and gently invert 8 to 10 times.
  2. Centrifuge for 10 minutes.
  3. Pre-squeeze transfer pipet bulb and draw off approximately 2/3 of the upper plasma layer.
    Note: This ensures that the buffy coat and red cells remain undisturbed.
  4. Aliquot plasma into labeled transport tube and cap tightly. Discard original tube.
  5. Store transport tube refrigerated at 2-8°C until ready to ship.

Special Instructions: Plasma must be separated from whole blood within 6 hours of collection by centrifugation. Transfer plasma to a sterile, screw-capped polypropylene tube. Store EDTA plasma refrigerated (2-8°C) once transferred.

Special Information: If EDTA plasma was not separated from red cells within 6 hours of collection and transported refrigerated, then the manufacturer’s requirements for the IVD reagent system have not been met and the following statements apply. “This test was developed and its performance characteristics determined by Cleveland Clinic’s Robert J. Tomsich Pathology and Laboratory Medicine Institute (RT-PLMI). It has not been cleared or approved by the FDA. RT-PLMI is regulated under CLIA as qualified to perform high complexity testing. This test is used for clinical purposes. It should not be regarded as investigational or for research.”

Transport: Store EDTA plasma at 2-8°C after collection and ship the same day per packaging instructions provided with the Cleveland HeartLab shipping box.

Stability:

Ambient (15-25°C): Not Acceptable
Refrigerated (2-8°C):
7 days
Frozen (-20°C):
6 weeks
Deep Frozen (-70°C):
Not Acceptable

Causes for Rejection: Specimens other than EDTA plasma; improper labeling; samples not stored properly; samples older than stability limits

Methodology: Polymerase Chain Reaction (PCR), Quant

Turn Around Time: 4-6 days

Reference Range:

Age Component (units) Normal Range
All Ages CMV DNA Specimen Source – Normal Not Applicable
All Ages CMV DNA (IU/mL) – Normal Negative for CMV DNA
All Ages CMV DNA (log IU/mL) – Normal Negative for CMV DNA
All Ages CMV DNA (copies/mL) – Normal Negative for CMV DNA

 

Clinical Significance: Detection and monitoring of CMV viral loads is indicated in patients at risk for progressive serious disease caused by this virus. Patients at risk include transplant recipients and patients with advanced HIV infection, among others. This test is used to monitor the amount of virus present in the blood of the patient and to initiate therapy or to suggest changing therapy.

The CPT codes provided 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 payer being billed.