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 | Collect saliva swab samples and place into a transport tube with transport media according to established laboratory methods. No special preparation of the neonate is required in order to collect the sample. |
| 5 mL | Urine, random | Sterile container | Ambient | Refrigerated | Specimen source required. Specimen must be transferred into cobas PCR Urine Sample Kit within 24 hours of collection. |
Minimum Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 1 mL |
Stability
| Environmental Condition | Description |
|---|---|
| Refrigerated | neat urine, 24 hours urine stabilized in cobas PCR media, 90 days saliva in UTM, 7 days |
| Ambient | neat urine, 24 hours urine stabilized in cobas PCR media, 90 days saliva, 48 hours |
| Frozen | saliva, 14 days if frozen immediately urine should not be frozen |
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.