Cytomegalovirus (CMV) DNA, Qualitative PCR, Non-Plasma
Test Mnemonic
CMVQL
CPT Codes
- 87496 - QTY (1)
LOINC ®
5000-5
Aliases
- cCMV
- CMVQL
- congenital CMV
- SQCMVQL
Includes
- CMV DNA
Performing Laboratory
Cleveland Clinic Laboratories
FDA Category
Laboratory Developed Test
Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 3 mL | Saliva | Universal Transport Media (UTM) | Refrigerated | Saliva swab specimens are only accepted from infants less than 21 days of age. Obtain a regular-tip flocked swab and tube containing 3 mL Universal Transport Medium (Oracle #1063581). Confirm that the infant has not been fed with human milk within the 1 hour before specimen collection. Infant can be held or remain in the bassinet for specimen collection. Wash hands and put gloves on. Remove the sterile flocked swab from its wrapping. Place the swab between the baby's cheek and gum on one side of the mouth. Keep the swab in place for 10-15 seconds. Move the swab to the other side of the mouth for another 10-15 seconds. Make sure the swab appears moist when removed. Remove the swab from the mouth and insert it into the UTM tube. Break off the swab tip. Close the cap. | |
| 5 mL | Urine, random | Sterile container | Refrigerated | Collect or transfer 5 mL of urine into a sterile, plastic, preservative-free container. Specimen must be transferred into cobas PCR Urine Sample Kit within 24 hours of collection. The correct volume of urine has been added when the fluid level is between the two black lines on the tube label. |
Minimum Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 1 mL | The minimum volume of saliva swab transport media or urine accepted is 1 mL. |
Stability
| Environmental Condition | Description |
|---|---|
| Refrigerated | 7 days for saliva swab in UTM; 24 hours for neat urine; 90 days for urine stabilized in cobas PCR media |
| Ambient | 48 hours for saliva swab in UTM; 24 hours for neat urine; 90 days for urine stabilized in cobas PCR media |
| Frozen | 14 days for saliva swab in UTM; Not acceptable for urine |
Days Performed
7 days a week
Turnaround Time
1 - 3 days
Methodology
| Name | Description |
|---|---|
| Real-Time Polymerase Chain Reaction (RT-PCR) |
Reference Range
| CMV DNA | |||||
|---|---|---|---|---|---|
| Sex | Age From | Age To | Type | Range | Range Unit |
| Normal | Not detected |
Special Info
CMVQL should only be used for saliva and urine. For EDTA plasma, utilize CMVQNT. For amniotic fluid, utilize CMVAMF. For all other specimen types (CSF, BAL, fluids, tissue, bone marrow), utilize CMVCSF.
Clinical Info
Cytomegalovirus (CMV) is a common viral pathogen that can cause severe disease in immunocompromised patients, and lead to a range of presentations in congenitally-exposed infants. The cobas CMV assay is an FDA-approved test for human EDTA plasma, which has been modified and validated as a lab-develop test to accept alternative sample types of saliva swabs in viral transport media and urine for qualitative CMV detection. The assay is a real-time PCR assay that targets highly-conserved regions of the CMV DNA polymerase (UL54) gene. The results of this test should be interpreted within the context of all relevant clinical and laboratory findings.
Clinical Limitation
For full limitations, refer to the assay instructions for use available on the manufacturer's website. The most important limitations are summarized as follows. Mutations within the highly-conserved regions of the CMV DNA polymerase (UL54) gene covered by cobas CMV may affect primers and/or probe binding resulting in the failure to detect the presence of virus. The cobas CMV mitigates this risk through the use of redundant amplification primers. Detection of CMV in patients >21 days of age is not specific for congenital CMV (cCMV), and could be the result of postnatal infection. Detection of CMV in saliva could be due to contamination from human milk feeding or other sources. Confirmation with a second specimen (ideally urine) is recommended. Samples containing mucin at concentrations >25 mg/mL may produce invalid results with the CMV assay. The results of this assay are not intended to be used as the sole basis for diagnosis, treatment, or other patient management decisions. Viral nucleic acid may persist in vivo, independent of viability, and the assay does not distinguish between viable and nonviable virus.
Clinical Reference
1. Leber AL. Maternal and congenital human cytomegalovirus infection: laboratory testing for detection and diagnosis. J Clin Microbiol. 2024 Apr 10;62(4):e0031323. doi: 10.1128/jcm.00313-23. Epub 2024 Feb 23. PMID: 38391188. 2. U.S. Food and Drug Administration (FDA). Premarket Approval Summary of Safety and Effectiveness Data P160041. Accessed July 5, 2024. https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160041B.pdf.