Cytomegalovirus (CMV) DNA, Qualitative PCR, Non-Plasma
Test Mnemonic
CMVQL
CPT Codes
- 87496 - QTY (1)
LOINC ®
4999-9, 83065-3
Performing Laboratory
Cleveland Clinic Laboratories
Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 3 mL | Saliva | Universal Transport Media (UTM) | Ambient | Refrigerated | Newborn saliva collection: * Saliva swab specimens are only accepted from infants less than 21 days of age. 1. Obtain a regular or mini-tip flocked swab and tube containing 3 mL Universal Transport Medium (Oracle #1063581/1035694; Diagnostic Hybrids #402C/403C). 2. Confirm that the baby was breastfed > 1 hour before specimen collection. 3. Baby can be held or remain in the bassinet for specimen collection. 4. Wash hands and put gloves on. 5. Remove the sterile flocked swab from its wrapping. 6. 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. 7. Move the swab to the other side of the mouth for another 10-15 seconds. Make sure the swab appears moist when removed. 8. Remove the swab from the mouth and insert it into the UTM tube. 9. Break off the swab tip. Close the cap. |
| 5 mL | Urine, random | Sterile container | Ambient | Refrigerated | Urine collection: 1. Collect or transfer at least 1 mL of urine into a sterile container. 2. 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 |
Stability
| Environmental Condition | Description |
|---|---|
| Refrigerated | 24 hours for neat urine; 90 days for urine stabilized in cobas PCR media; 7 days for saliva in UTM |
| Ambient | 24 hours for neat urine; 90 days for urine stabilized in cobas PCR media; 48 hours for saliva in UTM |
| Frozen | 14 days if frozen immediately for saliva; Not acceptable for urine |
Days Performed
7 days a week
Turnaround Time
1 - 3 days
Methodology
| Name | Description |
|---|---|
| Real-Time PCR |
Reference Range
Special Info
Testing will be performed daily, 7 days per week. Results should generally be available within 1-2 days of receipt in Molecular Microbiology.
Clinical Info
The CMV DNA Amplification Assay, performed on the cobas 8800 system, is a qualitative, in a lab-developed diagnostic test system for the direct detection of cytomegalovirus (CMV) DNA. Saliva swab specimens collected from children less than 21 days of age are intended to diagnose congenital CMV infection. Urine is conventionally used to confirm saliva CMV positives. CMV urine testing is also used as an aid in the diagnosis of CMV infection in transplant or otherwise immunocompromised patients. The results of this test should be used in conjunction with the results of other clinical findings.
Clinical Limitation
1. Saliva sample should be obtained at least one-hour after breast feeding to avoid contamination from cytomegalovirus which may result in a false positive result. Positive saliva screening tests should be followed by confirmatory urine CMV testing. 2. Samples containing mucin at concentrations >25 mg/mL may produce invalid results with the CMV assay. 3. The results of the CMV assay are not intended to be used as the sole basis for diagnosis, treatment, or other patient management decisions. 4. The CMV assay is a qualitative assay and does not provide quantitative values or information about viral load. 5. Viral nucleic acid may persist in vivo, independent of viability. The CMV assay does not distinguish between viable and nonviable virus.