EPIC Code

LAB3244
CMVPCR
CMVPCRUR

Performing Lab

UCHealth University of Colorado Hospital Clinical Laboratory - Molecular Diagnostics

Collect

Effective Jan 16th, 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 (minimum volume: >0.5 mL)
Minimum volume (non-urine): >0.2 mL

Specimen Preparation

BAL, bronchial wash, tracheal aspirate, CSF, eye fluid, or stool: Transfer 1 mL (Min: >0.2 mL) of sample to a sterile container.
Urine: Transfer 1 mL (Min: >0.5 mL) of urine to a 6 mL Clear Top. Also acceptable: Sterile container.
Buccal/oral swabs: See pediatric collection.
Tissue or bone marrow: ARUP

Pediatric Collection

Buccal/oral/saliva swab: Place flocked swab between infant’s cheek and gum, allow swab to become saturated with saliva. Place saturated swab in M6/VTM/UTM/sterile PBS. Do not use a wooden-shafted, calcium alginate, or cotton swab.
Also acceptable: Flocked swab in Clear Top or non-additive, sterile container.

Urine: Transfer 1 mL (Min: >0.5 mL) of urine to a Clear Top or sterile, non-additive container.

Unacceptable Conditions

  • Sources other than those listed (see LAB3243 for whole blood or plasma order).
  • Eye swabs.
  • Specimens (except buccal swabs) submitted in media.
  • ESwab®.
  • Wooden-shafted, calcium alginate, or cotton swabs.
  • Sample not properly identified, incorrect container, insufficient volume, or past stability.
  • 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 urine (CMVPCRUR):
  • Urine in preservative or non-sterile container.
  • Frozen urine.

Storage/Transport Temperature

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

Performed

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

Stability (from collection to initiation)

Urine (CMVPCRUR):
Room Temp: 24 hours
Refrigerated: 3 days
Frozen: Unacceptable

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

Remarks

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.

Performed

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

Methodology

Real-time PCR

Reported

1–3 days

Synonyms

  • CMVPCR
  • Cytomegalovirus PCR
  • HHV-5
  • CMVPCRUR
  • CMV PCR Urine
  • CMV PCR
  • CMV PCR (sources other than blood)

Ordering Recommendations

For CMV blood (EDTA plasma or whole blood) testing see LAB3243.

EPIC Code

LAB3244
CMVPCR
CMVPCRUR

Reference Interval

Not detected
0 IU/mL

Interpretive Data

Urine (CMVPCRUR):
Interpretation (urine):  
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 (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.

CPT Codes

87497 (quantitative)
87496 (qualitative)

Collection

EPIC Code

LAB3244
CMVPCR
CMVPCRUR

Performing Lab

UCHealth University of Colorado Hospital Clinical Laboratory - Molecular Diagnostics

Collect

Effective Jan 16th, 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 (minimum volume: >0.5 mL)
Minimum volume (non-urine): >0.2 mL

Specimen Preparation

BAL, bronchial wash, tracheal aspirate, CSF, eye fluid, or stool: Transfer 1 mL (Min: >0.2 mL) of sample to a sterile container.
Urine: Transfer 1 mL (Min: >0.5 mL) of urine to a 6 mL Clear Top. Also acceptable: Sterile container.
Buccal/oral swabs: See pediatric collection.
Tissue or bone marrow: ARUP

Pediatric Collection

Buccal/oral/saliva swab: Place flocked swab between infant’s cheek and gum, allow swab to become saturated with saliva. Place saturated swab in M6/VTM/UTM/sterile PBS. Do not use a wooden-shafted, calcium alginate, or cotton swab.
Also acceptable: Flocked swab in Clear Top or non-additive, sterile container.

Urine: Transfer 1 mL (Min: >0.5 mL) of urine to a Clear Top or sterile, non-additive container.

Unacceptable Conditions

  • Sources other than those listed (see LAB3243 for whole blood or plasma order).
  • Eye swabs.
  • Specimens (except buccal swabs) submitted in media.
  • ESwab®.
  • Wooden-shafted, calcium alginate, or cotton swabs.
  • Sample not properly identified, incorrect container, insufficient volume, or past stability.
  • 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 urine (CMVPCRUR):
  • Urine in preservative or non-sterile container.
  • Frozen urine.

Storage/Transport Temperature

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

Performed

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

Stability (from collection to initiation)

Urine (CMVPCRUR):
Room Temp: 24 hours
Refrigerated: 3 days
Frozen: Unacceptable

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

Remarks

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.

Ordering

Performed

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

Methodology

Real-time PCR

Reported

1–3 days

Synonyms

  • CMVPCR
  • Cytomegalovirus PCR
  • HHV-5
  • CMVPCRUR
  • CMV PCR Urine
  • CMV PCR
  • CMV PCR (sources other than blood)

Ordering Recommendations

For CMV blood (EDTA plasma or whole blood) testing see LAB3243.

EPIC Code

LAB3244
CMVPCR
CMVPCRUR

Result Interpretation

Reference Interval

Not detected
0 IU/mL

Interpretive Data

Urine (CMVPCRUR):
Interpretation (urine):  
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 (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.

Administrative

CPT Codes

87497 (quantitative)
87496 (qualitative)

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