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Cytomegalovirus (CMV) DNA Quantitation by PCR

Human CMV, hCMV, Viral Load, CMV Quantification, Herpesvirus, HHV-5

Test Codes

EPIC: LAB9130, Beaker: CMV

Department

Molecular Pathology

Specimen Collection Criteria

Collect: One Lavender-top EDTA tube.

• Preferred: 1mL; Minimum: 0.500 mL
• Separate samples must be submitted when multiple tests are ordered.

Physician Office/Draw Specimen Preparation

Centrifuge to separate plasma from cells within 24 hours of collection.

Collect enough whole blood to allow for a minimum of 1 mL of plasma. Whole blood collected in EDTA tubes are stable for up to 24 hours at room temperature (20-26°C or 68-78.8°F) or refrigerated (2-8°C or 36-46°F) prior to centrifugation.

After centrifugation, transfer all available plasma to a sterile plastic transport tube and refrigerate (2-8°C or 36-46°F). Plasma or serum samples may be stored refrigerated (2-8°C or 36-46°F) for up to 6 days.

Preparation for Courier Transport

Transport:

• Uncentrifuged whole blood can be transported at room temperature (20-26°C or 68-78.8°F) or refrigerated (2-8°C or 36-46°F) if processed within 24 hours of collection.
• Plasma, refrigerated (2-8°C or 36-46°F). Freezing plasma is no longer required if delivered to the lab within 6 days of collection.

Rejection Criteria

• Specimens not centrifuged with plasma separated within 24 hours of collection.
• Specimens not collected in Lavender-top EDTA tubes.
• Specimens not maintained refrigerated following separation.
• Specimens exposed to repeated freeze/thaw cycles.
• Specimens which yield less than 0.5 mL plasma.
• Unlabeled tubes.

In-Lab Processing

Specimens must be centrifuged with plasma or serum separated from cells within 24 hours of collection. After centrifugation, please ensure that all available plasma or serum is transferred to a sterile plastic transport tube.

Storage

Specimen Stability for Testing:

Room Temperature (20-26°C or 68-78.8°F): 24 hours
Refrigerated (2-8°C or 36-46°F): 6 days – Centrifuged plasma only
Frozen (-20°C/-4°F or below): 12 weeks – Centrifuged plasma only

Specimen Storage in Department Prior to Disposal:

Frozen (-20°C/-4°F or below): 4 weeks

Laboratory

Royal Oak Molecular Pathology Laboratory

Performed

At least once per week (Tuesday).
Results available within 7–10 days.

Reference Range

CMV DNA not detected. The analytical sensitivity is 35 IU/mL (plasma).

Reportable range is 35 - 10,000,000 IU/mL. Results exceeding 10,000,000 will not be diluted and will be reported as greater than 10,000,000 IU/mL.

NOTE: CMV DNA (copies/mL) = CMV DNA result (IU/mL) x 1.1 copies/IU.

Test Methodology

Quantitative real-time polymerase chain reaction (qPCR)-Roche COBAS® 6800 CMV (FDA Approved).

Clinical Utility

• This test is intended for use as an aid in the management of solid-organ transplant patients who are undergoing anti-CMV therapy. In this population serial DNA measurements can be used to assess virological response to antiviral treatment. The results of this test should be interpreted within the context of all relevant clinical and laboratory findings.
• The lower limit of reporting in this assay is less than 35 IU/mL. A result reported as “detected” less than 35 IU/mL indicates the presence of CMV DNA concentrations below the level of quantitation of the assay.
• This test is NOT intended for use as a screening test for the presence of CMV DNA in blood or blood products.

CPT Codes

87497

Contacts

Last Updated

8/19/2024