EPIC Code

LAB3243
CMVPCRBLD
CMVPCRPLS

Performing Lab

UCHealth University of Colorado Hospital Clinical Laboratory - Molecular Diagnostics

Collect

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

Specimen Preparation

Whole blood (CMVPCRBLD): 1 mL of EDTA whole blood (Min: >0.2).

Plasma (CMVPCRPLS): Separate plasma from cells within 24 hours of collection. Transfer 1 mL plasma (Min: >0.5) in a sterile container.

Unacceptable Conditions

  • Blood collected in containers other than EDTA.
  • Plasma from green tops (LiHep or NaHep).
  • 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 CMV PCR Whole Blood (CMVPCRBLD):

  • EDTA plasma.

Additionally, for CMV PCR - Plasma (CMVPCRPLS):

  • EDTA plasma not separated from cells within 24 hours of collection.
  • Grossly hemolyzed plasma.
  • Frozen whole blood.

Storage/Transport Temperature

Internal: Ambient
Offsite: Refrigerated

Performed

Day shift: Daily

Stability (from collection to initiation)

EDTA whole blood (CMVPCRBLD):
Room Temp: 24 hours
Refrigerated: 3 days
Frozen: 6 months

EDTA plasma (CMVPCRPLS):
Room Temp: 24 hours
Refrigerated: 6 days
Frozen: 6 months
Note: EDTA plasma must be separated from cells within 24 hours of collection.

Remarks

Specimen source must be identified on order or requisition.

Order Specimen Source = “Blood” for whole blood test (CMVPCRBLD); Specimen Source=“Plasma” for plasma test (CMVPCRPLS).

Performed

Day shift: Daily

Methodology

Quantitative Real-time PCR using cobas® 6800 System

Reported

1–3 days

Synonyms

  • CMVPCRBLD
  • CMVPCRPLS
  • Cytomegalovirus PCR
  • HHV-5
  • CMV PCR Whole blood
  • CMV PCR Plasma

Ordering Recommendations

Whole blood (CMVPCRBLD) vs. plasma (CMVPCRPLS) testing is determined by which Specimen Source ("Blood" or "Plasma") is selected during ordering. Changing the Specimen Source after collection/printing a label will not change the test.

EPIC Code

LAB3243
CMVPCRBLD
CMVPCRPLS

Reference Interval

0 IU/mL

Interpretive Data

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

Methodology:
Nucleic acid amplification test (NAAT)

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.

CPT Codes

87497
Collection

EPIC Code

LAB3243
CMVPCRBLD
CMVPCRPLS

Performing Lab

UCHealth University of Colorado Hospital Clinical Laboratory - Molecular Diagnostics

Collect

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

Specimen Preparation

Whole blood (CMVPCRBLD): 1 mL of EDTA whole blood (Min: >0.2).

Plasma (CMVPCRPLS): Separate plasma from cells within 24 hours of collection. Transfer 1 mL plasma (Min: >0.5) in a sterile container.

Unacceptable Conditions

  • Blood collected in containers other than EDTA.
  • Plasma from green tops (LiHep or NaHep).
  • 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 CMV PCR Whole Blood (CMVPCRBLD):

  • EDTA plasma.

Additionally, for CMV PCR - Plasma (CMVPCRPLS):

  • EDTA plasma not separated from cells within 24 hours of collection.
  • Grossly hemolyzed plasma.
  • Frozen whole blood.

Storage/Transport Temperature

Internal: Ambient
Offsite: Refrigerated

Performed

Day shift: Daily

Stability (from collection to initiation)

EDTA whole blood (CMVPCRBLD):
Room Temp: 24 hours
Refrigerated: 3 days
Frozen: 6 months

EDTA plasma (CMVPCRPLS):
Room Temp: 24 hours
Refrigerated: 6 days
Frozen: 6 months
Note: EDTA plasma must be separated from cells within 24 hours of collection.

Remarks

Specimen source must be identified on order or requisition.

Order Specimen Source = “Blood” for whole blood test (CMVPCRBLD); Specimen Source=“Plasma” for plasma test (CMVPCRPLS).
Ordering

Performed

Day shift: Daily

Methodology

Quantitative Real-time PCR using cobas® 6800 System

Reported

1–3 days

Synonyms

  • CMVPCRBLD
  • CMVPCRPLS
  • Cytomegalovirus PCR
  • HHV-5
  • CMV PCR Whole blood
  • CMV PCR Plasma

Ordering Recommendations

Whole blood (CMVPCRBLD) vs. plasma (CMVPCRPLS) testing is determined by which Specimen Source ("Blood" or "Plasma") is selected during ordering. Changing the Specimen Source after collection/printing a label will not change the test.

EPIC Code

LAB3243
CMVPCRBLD
CMVPCRPLS

Result Interpretation

Reference Interval

0 IU/mL

Interpretive Data

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

Methodology:
Nucleic acid amplification test (NAAT)

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.

Administrative

CPT Codes

87497

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