Test Overview
Test Methodology

Real-time Polymerase chain reaction (PCR)

Test Usage

This test is intended for the detection of CMV from saliva swabs and urine from infants less than 21 days of age. The results of this assay should be used in conjunction with the results of other clinical findings as an aid in the diagnosis of congenital CMV infection. Positive results from saliva are presumptive and should be confirmed with CMV PCR from urine or dried blood spot.

Reference Range *

Not detected

* Reference ranges may change over time. Please refer to the original patient report when evaluating results.

Test Limitations

This test is not validated for sample types other than saliva swab and urine specimens from infants less than 21 days of age or younger.
Negative results do not preclude cytomegalovirus (CMV) infection and should not be used as the sole basis for treatment or other patient management decisions
The performance of this test has not been established for monitoring treatment of CMV infection.

Test Details
Days Set Up
Monday - Sunday
Analytic Time

24 hours

Soft Order Code
Specimen Requirements
Collection Instructions

Saliva specimens: Confirm that the baby last consumed breast milk or was put to breast > 1 hour prior to collection of the sample. Wash hands and put gloves on, then proceed to open the sterile flocked swab. Introduce the swab between the cheek and the gum in one side of the mouth. Allow to sit for 10-15seconds. Move the swab tip to the other side of the mouth for another 10-15 seconds. Make sure the swab appears moistened when removed. Remove the swab from the mouth and place in transport medium. Snap off shaft and cap tube tightly.
Saliva swab specimens processed for testing within 48 hours post collection can be sent/stored at 18°C to 25°C.
If there is a greater than 2 days delay before receipt of the specimen by the lab, store the specimen for up to 14 days at -20 ±10 °C.

Urine specimens: Neat urine collected from urine bags/containers/catheters.
Urine specimens must be sent to lab frozen (-20 °C) and maintained frozen during shipment. Once received by lab, urine specimens are maintained frozen at -20 °C until testing (up to 3 days).

False-negative results may occur if the viral nucleic acid is present at a level below the analytical sensitivity of the assay, if the virus has genomic mutations, insertions, deletions, or rearrangements, or if the assay is performed very early in the course of illness. This test has not been cleared for screening of blood or blood products for the presence of CMV or for use with samples other than urine and saliva swabs. False-positive results may occur if used in infants >21 days of age as after that time it becomes difficult to distinguish congenital infection from postnatal infection.
Normal Volume
1 swab in viral transport media
5 mL Urine in sterile container
Minimum Volume
1 swab in viral transport media
.5 mL Urine in sterile container
Storage Temperature
Rejection Criteria
Specimens send on patient >21 days of age without prior approval.
CPT Code
Fee Code