CYTOMEGALOVIRUS DNA, QUANTITATIVE

Test Documentation
Specimen Required
Specimen source required
Draw blood in a lavender EDTA tube. Centrifuge and separate plasma from cells within 6 hours of collection. Send 2.0 mL plasma (1.0 mL minimum) frozen in a screw-capped plastic vial. Dedicated specimens are required. Specimens used in other assays will not be tested.

Alternate Specimen
CSF: Send 2.0 mL CSF (1.0 mL minimum) undiluted, and frozen in in a screw-capped plastic vial.
Urine: Send 2.0 mL urine (1.0 mL minimum) undiluted, and frozen in in a screw-capped plastic vial.
Amniotic Fluid, 1.0 mL (0.5 mL minimum) in in a screw-capped plastic vial.
The Laboratory Director or Supervisor must approve testing of specimens other than those listed above.

Rejection Criteria
The following specimens will not be tested:
Serum specimens
Heparinized specimens
Specimens in any gel-based plasma-separation media
Shared specimens
Specimens submitted to repeated freeze-thaw cycles
Urine in Grey-Top (boric acid) urine Vacutainers
Specimens received in non-sterile or leaking containers
Specimens that do not meet the storage/handling conditions criteria above
Stool

Methodology
This test utilizes the polymerase chain reaction to amplify a 60 base pair region of the cytomegalovirus (CMV) DNA polymerase gene. Real-time detection and quantification are used to determine the viral copy number. The analytical measurement range is 250 to 5 million copies/mL (2.40 to 6.70 log(10) copies/mL). The qualitative limit of detection is 160 copies/mL (2.20 log(10) copies/mL) compared to the WHO International Standard, 1 IU=1.72 copies/mL.
Specimens reported as POSITIVE but <250 copies/mL contain detectable levels of CMV DNA but the viral load is below the limit of quantitation. A negative result does not rule out infection.

Stability
Room Temperature: 24 hours; Refrigerated: 3 days; Frozen (-20°C): 30 days; Frozen (-70°C): 6 months

Reference Range
<250 copies/mL
<2.40 log(10) copies/mL

Performed
Monday-Friday

Turnaround Time1-3 days
Test CodeCMVQN
CPT-4 Code (s)
87497
LOINC Codes
CMV   33006-8  
Source   31208-2  

Warde
Medical
Laboratory