Topic:
CMV
Quantification by PCR
Testing to be performed at Avera McKennan Regional
Laboratory
Effective
Date: December 17,
2007
Test
Name: CMV Quantification by
PCR
CPT:
87497
Test
Mnemonic:
CMVPCR
Performed:
Monday, Wednesday, and
Friday
Reported:
1-3 days
Specimen
Requirements: One 5ml lavender
(EDTA). Remove EDTA plasma from cells and freeze in a sterile
polypropylene tube.
Transport:
1ml plasma, frozen.
Pediatric
Collection/Transport:
Same as above.
Unacceptable:
Serum or heparinized
plasma.
Stability:
Ambient: 8 hours.
Refrigerated: 3 days. Frozen: 3
months.
Interpretation:
1. Negative
a. Comments:
Cytomegalovirus DNA not detected by PCR.
b. Interpretive comment:
A negative result does not rule out the presence or absence of PCR inhibitors in
the patient specimen or cytomegalovirus DNA concentrations below the level of
detection of the assay.
2. Positive
a. Comments: Copies/ml.
(Numerical Value) Cytomegalovirus DNA detected by
PCR.
b. Interpretive comment:
A positive test result should not be used as the only criterion to form a
clinical conclusion. Results should be correlated with other serological
tests, patient symptoms, and clinical presentation.
3. All interpretations will
include the following comment:
a. This test was developed
using commercial Analyte Specific Reagents and its performance characteristics
determined by Avera McKennan laboratory. It has not received FDA 510 K
clearance nor been approved by the U.S. Food and Drug
Administration.