LAB3244
CMVPCR
CMVPCRUR

UCHealth University of Colorado Hospital Clinical Laboratory - Molecular Diagnostics

Effective Jan 16^th, 2023, this test can only be performed in-house on the following sources:

• Amniotic fluid
• Bronchoalveolar lavage (BAL) or bronchial wash
• Tracheal aspirate
• CSF
• Eye fluid
• Buccal/oral swab
• Stool
• Urine (received within 24 hours of collection strongly preferred). Minimum volume: 0.5 mL.

• Sources other than those listed cannot be performed in-house.
• Eye swabs.
• eSwabs.
• Wooden-shafted or cotton swabs.
• Sample not properly identified, incorrect container, insufficient volume, past stability, or leaking container.

• Urine in preservative or non-sterile container.
• Frozen urine.
• Lab Note: Samples processed in lab using non-sterile technique—including samples previously tested with a “common needle” on an instrument—are unacceptable.

Internal: Ambient
Offsite: Refrigerated. Do not freeze urine.

Urine (CMVPCRUR): Day shift: Daily
Other sources (CMVPCR): Day shift: Monday–Friday

Urine:
Room Temp (strongly preferred): 24 hours
Refrigerated (strongly preferred): 24 hours
Frozen: Unacceptable

Other Sources:
Room Temp: 12 hours
Refrigerated: 3 days
Frozen: ≥31 days

Specimen source must be identified on order or requisition.

Quantitative results will be reported for CSF, BAL, bronch wash, tracheal aspirate, amniotic fluid, and eye fluid.
Qualiative results will be given for urine, buccal/oral swabs, stool, or diluted samples.

Urine (CMVPCRUR): Day shift: Daily
Other sources (CMVPCR): Day shift: Monday–Friday

Real-time PCR

1–3 days

LAB3244
CMVPCR
CMVPCRUR

Urine (CMVPCRUR):
Interpretation:  
Not detected = No virus detected.  
Detected = Virus detected.  

Methodology (urine):  
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 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.

Other Sources (or urine >24h old) (CMVPCR):
Interpretation:
Not detected = No virus detected.
Detected = Virus detected.
<1,000 IU/mL = Virus detected below the minimum quantitative range.
1,000 IU/mL to 1,000,000 IU/mL = Virus detected within quantitative range.
>1,000,000 IU/mL = Virus detected above maximum quantitative range.

Methodology:
This test employs real-time PCR amplification of a Cytomegalovirus-specific conserved genetic target. 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 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.

87497 (quantitative)
87496 (qualitative)