EPIC Code

LAB3244
CMVPCR
CMVPCRbuccal
CMVPCRUR

Performing Lab

UCHealth University of Colorado Hospital Clinical Laboratory - Molecular Diagnostics

Collect

Specimen Source 
  • Amniotic fluid
  • Bronchoalveolar lavage (BAL) or bronchial wash
  • Tracheal aspirate
  • CSF
  • Eye fluid
  • Stool
  • Urine
     

Minimum volume (non-urine): >0.2 mL
Minimum volume (urine): >0.3 mL
  • Buccal/oral swab

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.
Buccal/oral swabs: See pediatric collection.Urine: Transfer 1 mL (Min: >0.3 mL) of urine to a 6 mL Clear Top. Also acceptable: Sterile container.
Tissue or bone marrow: ARUP (qualitative)

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: >0.3 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 preservative or media.
  • 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 (e.g., Sysmex)—are unacceptable.
Additionally, for buccal swabs (CMVPCRbuccal):
  • ESwab®.
  • Wooden-shafted, calcium alginate, or cotton swabs.
Additionally, for urine (CMVPCRUR):
  • Urine in preservative or non-sterile container.
  • Grossly bloody urine
  • Frozen urine.

Storage/Transport Temperature

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

Performed

Buccal swabs and Urine (CMVPCRbuccal and CMVPCRUR): Day shift: Daily
Other sources (CMVPCR): Day shift: Monday–Friday

Stability (from collection to initiation)

Buccal (CMVPCRbuccal):
Room Temp: 24 hours
Refrigerated: 3 days
Frozen: 6 months

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

Buccal swabs and Urine (CMVPCRbuccal and 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
  • CMV PCR
  • CMV PCR (sources other than blood)
  • CMV Quantitative PCR
  • CMV PCR Quantitative
  • CMVPCRUR
  • CMV PCR Urine
  • CMV PCR - Buccal
  • CMVPCRbuccal
  • CMV PCR Qualitative
  • CMV Qualitative PCR
  • 0060040 Cytomegalovirus by Qualitative PCR

Ordering Recommendations

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

Test (CMVPCR, CMVPCRbuccal, CMVPCRUR, CMVPCRBLD, CMVPCRPLS) is determined by which Specimen Type and Specimen Source is selected during ordering. Changing the Specimen Source after collection/printing a label will not change the test.

EPIC Code

LAB3244
CMVPCR
CMVPCRbuccal
CMVPCRUR

Reference Interval

Not detected
0 IU/mL

Interpretive Data

Buccal (CMVPCRbuccal):
Component Result Comment (buccal):
CMV Not Detected
An interpretation of “Not Detected” does not rule out the presence of inhibitors or CMV DNA concentration below the limit of detection of the assay.

Result Comment (buccal):  
The CMV buccal swab assay is a qualitative nucleic acid amplification test for the detection of CMV using the cobas 6800 system. This assay is based on the in vitro CMV nucleic acid amplification test and has been modified for use with buccal swab specimens. The analytical performance characteristics were established by the UCHealth Molecular Diagnostics Laboratory. The specimen type has not been cleared or approved by the U.S. Food and Drug Administration. This test was performed in a CLIA-certified laboratory and is intended for clinical use.

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
CMVPCRbuccal
CMVPCRUR

Performing Lab

UCHealth University of Colorado Hospital Clinical Laboratory - Molecular Diagnostics

Collect

Specimen Source 
  • Amniotic fluid
  • Bronchoalveolar lavage (BAL) or bronchial wash
  • Tracheal aspirate
  • CSF
  • Eye fluid
  • Stool
  • Urine
     

Minimum volume (non-urine): >0.2 mL
Minimum volume (urine): >0.3 mL
  • Buccal/oral swab

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.
Buccal/oral swabs: See pediatric collection.Urine: Transfer 1 mL (Min: >0.3 mL) of urine to a 6 mL Clear Top. Also acceptable: Sterile container.
Tissue or bone marrow: ARUP (qualitative)

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: >0.3 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 preservative or media.
  • 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 (e.g., Sysmex)—are unacceptable.
Additionally, for buccal swabs (CMVPCRbuccal):
  • ESwab®.
  • Wooden-shafted, calcium alginate, or cotton swabs.
Additionally, for urine (CMVPCRUR):
  • Urine in preservative or non-sterile container.
  • Grossly bloody urine
  • Frozen urine.

Storage/Transport Temperature

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

Performed

Buccal swabs and Urine (CMVPCRbuccal and CMVPCRUR): Day shift: Daily
Other sources (CMVPCR): Day shift: Monday–Friday

Stability (from collection to initiation)

Buccal (CMVPCRbuccal):
Room Temp: 24 hours
Refrigerated: 3 days
Frozen: 6 months

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

Buccal swabs and Urine (CMVPCRbuccal and 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
  • CMV PCR
  • CMV PCR (sources other than blood)
  • CMV Quantitative PCR
  • CMV PCR Quantitative
  • CMVPCRUR
  • CMV PCR Urine
  • CMV PCR - Buccal
  • CMVPCRbuccal
  • CMV PCR Qualitative
  • CMV Qualitative PCR
  • 0060040 Cytomegalovirus by Qualitative PCR

Ordering Recommendations

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

Test (CMVPCR, CMVPCRbuccal, CMVPCRUR, CMVPCRBLD, CMVPCRPLS) is determined by which Specimen Type and Specimen Source is selected during ordering. Changing the Specimen Source after collection/printing a label will not change the test.

EPIC Code

LAB3244
CMVPCR
CMVPCRbuccal
CMVPCRUR

Result Interpretation

Reference Interval

Not detected
0 IU/mL

Interpretive Data

Buccal (CMVPCRbuccal):
Component Result Comment (buccal):
CMV Not Detected
An interpretation of “Not Detected” does not rule out the presence of inhibitors or CMV DNA concentration below the limit of detection of the assay.

Result Comment (buccal):  
The CMV buccal swab assay is a qualitative nucleic acid amplification test for the detection of CMV using the cobas 6800 system. This assay is based on the in vitro CMV nucleic acid amplification test and has been modified for use with buccal swab specimens. The analytical performance characteristics were established by the UCHealth Molecular Diagnostics Laboratory. The specimen type has not been cleared or approved by the U.S. Food and Drug Administration. This test was performed in a CLIA-certified laboratory and is intended for clinical use.

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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