LAB3243
CMVPCRBLD
CMVPCRPLS

UCHealth University of Colorado Hospital Clinical Laboratory - Molecular Diagnostics

Preferred: 6 mL Pink (K2 EDTA)
Acceptable: 4 mL Purple (EDTA)

• Blood collected in containers other than EDTA.
• Heparinized specimens (LiHep or NaHep).
• Sample not properly identified, incorrect container, insufficient volume, past stability, or leaking container.
• Lab Note: Samples processed in lab using non-sterile technique—including samples previously tested with a “common needle” on an instrument—are unacceptable.

Additionally, for CMV PCR Whole Blood (CMVPCRBLD):

• EDTA plasma.

Additionally, for CMV PCR - Plasma (CMVPCRPLS):

• Plasma not separated from cells within 24 hours of collection.
• Frozen whole blood.
• Serum.

Internal: Ambient
Offsite: Refrigerated

Day shift: Monday–Friday

Whole blood:
Room Temp: 12 hours
Refrigerated: 3 days
Frozen: ≥6 months

EDTA plasma:
Room Temp: 24 hours
Refrigerated: 6 days
Frozen: ≥3 months

Day shift: Monday–Friday

Quantitative Real-time PCR

1–3 days

LAB3243
CMVPCRBLD
CMVPCRPLS

Whole Blood (CMVPCRBLD):
Interpretation:
Not detected = Negative, no virus detected
<1000 IU/mL = Positive.  Virus detected below 1000 IU/mL
1000 IU/mL to 1,000,000 IU/mL = Positive
>1,000,000 IU/mL = Positive. Virus detected above maximum quantitative range.

Methodology:
This test employs real-time PCR amplification of a Cytomegalovirus-specific conserved genetic target. A positive result should be coupled with clinical indicators for diagnosis. A "Not detected" result for this assay does not exclude Cytomegalovirus involvement in a disease process. This test was developed and its performance characteristics determined by the UCH Clinical Laboratory.  It has not been cleared or approved by the U.S. Food and Drug Administration.  The FDA has determined that such clearance or approval is not necessary.  This test is used for clinical purposes.  It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendment of 1988 ("CLIA") as qualified to perform high complexity clinical testing.

Plasma (CMVPCRPLS):
Interpretation:
Not detected = No virus detected.
Detected = Virus detected.
<35 IU/mL = Virus detected below the minimum quantitative range.
35 IU/mL to 10,000,000 IU/mL = Virus detected within quantitative range.
>10,000,000 IU/mL = Virus detected above maximum quantitative range.

Methodology (plasma):
This CMV DNA real-time assay utilizes the Roche cobas 6800 CMV test. A detected result should be coupled with clinical indicators for diagnosis.  A not detected result for this assay does not exclude Cytomegalovirus involvement in a disease process. This test has been approved by the U.S. Food and Drug Administration. This laboratory is certified under the Clinical Laboratory Improvement Amendment of 1988 ("CLIA") as qualified to perform high complexity clinical testing.

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