Cytomegalovirus (CMV), Congenital, Qualitative PCR, Urine
Use
This test is intended for the in vitro qualitative detection of cytomegalovirus (CMV) DNA from urine from infants <21 days of age. 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.
Special Instructions
Urine should be collected in a sterile urine cup or transport tube without preservatives. The specimen must be frozen within 8 hours of collection to ensure sample integrity. Testing schedules may vary, and additional time may be required for confirmatory or reflex tests.
Limitations
Results must be interpreted with consideration of the clinical context. Proper specimen handling and preparation are crucial as improper procedures can lead to inaccurate results. Negative results do not exclude CMV infection and false negatives may occur if the virus load is below detection sensitivity. Additionally, mutations and sample timing may affect results. False positives may occur based on viral prevalence.
Methodology
PCR-based (PCR)
Biomarkers
LOINC Codes
- 4999-9
- 4999-9
Result Turnaround Time
2-3 days
Related Documents
For more information, please review the documents below
Specimen
Urine
Volume
1 mL
Minimum Volume
0.5 mL
Container
Urine transport cup or tube (without preservatives)
Collection Instructions
Urine should be collected in a sterile urine cup or transport tube without preservatives.
Storage Instructions
Urine specimens must be frozen (-20°C) within 8 hours of collection.
Causes for Rejection
Urine specimens submitted with preservative or transport media; nonfrozen specimens; urine specimens not meeting the minimum specimen volume; specimens submitted from patients >21 days old
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Unacceptable |
| Refrigerated | Unacceptable |
| Frozen | 3 days (-20°C); > 3 days (< -70°C) |