Test Details
Methodology
Polymerase chain reaction (PCR)
Result Turnaround Time
2 - 3 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
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.
Limitations
Results from this test must be considered in conjunction with clinical history, epidemiological data and other laboratory information available to the clinician evaluating the patient.
The detection of viral nucleic acid is dependent on proper sample collection, transport, handling, storage and preparation. Failure to observe proper procedures in any of these steps can lead to incorrect results.
Negative results do not rule out congenital CMV infections and should net be used as the sole basis for treatment or other management decisions.
False negative results may occur if the viruses are present at a level that is below the analytical sensitivity of the assay or if the virus has nutations, insertions, deletions or rearrangements.
The prevalence of viral infections may affect the test's predictive value. As with other tests, false positive results may occur.
Specimen Requirements
Specimen
Urine
Volume
1 mL
Minimum Volume
0.5 mL (Note: This volume does not allow for repeat testing.)
0.5 mL |
0.5 mL (Note: This volume does not allow for repeat testing.) |
Container
Urine transport cup or tube (without preservatives)
Collection Instructions
Urine should be collected in a sterile urine cup or transport tube without preservatives.
Stability Requirements
| Temperature | Period |
|---|---|
| Room temperature | Unacceptable |
| Refrigerated | Unacceptable |
| Frozen | 3 days (-20°C) > 3 days (< -70°C) |
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
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 139840 | Congenital CMV PCR, Urine | 4999-9 | 139841 | Cytomegalovirus (CMV), DNA | 4999-9 | |
| Order Code | 139840 | |||||
| Order Code Name | Congenital CMV PCR, Urine | |||||
| Order Loinc | 4999-9 | |||||
| Result Code | 139841 | |||||
| Result Code Name | Cytomegalovirus (CMV), DNA | |||||
| UofM | ||||||
| Result LOINC | 4999-9 |