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HelpTest Code CCMVU Congenital Cytomegalovirus (cCMV), Molecular Detection, PCR, Urine
Ordering Guidance
This test should be ordered to test urine specimens from patients aged 21 days or younger. To test urine from patients older than 21 days, order CMVPV / Cytomegalovirus (CMV) Molecular Detection, PCR, Varies.
To test saliva specimens from patients aged 21 days or younger, order CCMVS / Congenital Cytomegalovirus (cCMV), Molecular Detection, PCR, Saliva. To test saliva from patients older than 21 days, order CMVPV / Cytomegalovirus (CMV) Molecular Detection, PCR, Varies.
Specimen Required
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Container/Tube: Plastic sterile container, 5 mL
Specimen Volume: 0.2 mL
Collection Instruction:
1. Collect a random urine from a urine bag, container, or catheter.
2. Transfer urine to sterile container.
3. No preservative
Useful For
Aiding in the rapid diagnosis of cytomegalovirus infections in neonates 21 days of age or younger using urine specimens
Reporting Name
Congenital CMV, PCR, UrineSpecimen Type
UrineSpecimen Minimum Volume
0.1 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Urine | Frozen | 72 hours |
Reject Due To
All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.Reference Values
Negative
Supportive Data
Accuracy:
To assess the accuracy of the Simplexa Congenital CMV (cytomegalovirus) Direct assay, clinical urine specimens (n=60) were tested and the results compared to those of a routine, lab-developed (LDT) CMV polymerase chain reaction (PCR) assay.(4) Results are summarized below in the Table.
Table. Urine Accuracy
|
Simplexa Congenital CMV Direct results |
CMV LDT PCR results |
|
|
|
Positive |
Negative |
|
Positive |
31(a) |
0 |
|
Negative |
2(b) |
26 |
|
Invalid |
1(c) |
0 |
a. One sample initially positive by CMV LDT PCR tested negative after frozen storage, but repeated positive results were obtained in triplicate by CMV LDT PCR (crossing point range: 36.94 to 40.00), and the sample was therefore included in accuracy experiments.
b. Two samples were negative by Simplexa but noted to have amplification curves and cycle threshold values (38.3 and 40.3) visible within the software, but outside of the defined positivity cutoff per the manufacturers instructions for use (≤37.5). These samples were also positive by CMV LDT (Cp, 36.62 and 36.94 to 40.00 [see footnote a]), indicating the presence of CMV DNA at or below the limit of detection of the Simplexa cCMV Direct assay.
c. There was one initial Simplexa internal control failure; the urine sample was retested by Simplexa in singlet but repeated as invalid.
Simplexa cCMV Direct assay accuracy results for urine samples produced 91% positive agreement, 100% negative agreement, and 95% overall agreement.
Day(s) Performed
Monday through Sunday
Report Available
Same day/1 to 2 daysSpecimen Retention Time
3 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
CPT Code Information
87496
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| CCMVU | Congenital CMV, PCR, Urine | 4999-9 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 620658 | Congenital CMV, PCR, Urine | 4999-9 |