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HelpTest Code CCMVS Congenital Cytomegalovirus (cCMV), Molecular Detection, PCR, Saliva
Ordering Guidance
This test should be ordered to test saliva specimens from patients 21 days old or younger. To test saliva from patients older than 21 days, order CMVPV / Cytomegalovirus (CMV) Molecular Detection, PCR, Varies.
To test urine specimens from patients 21 days or younger, order CCMVU / Congenital Cytomegalovirus (cCMV), Molecular Detection, PCR, Urine. To test urine from patients older than 21 days, order CMVPV / Cytomegalovirus (CMV) Molecular Detection, PCR, Varies.
For CMV testing on plasma specimens, order CMVQN / Cytomegalovirus (CMV) DNA Detection and Quantification by Real-Time PCR, Plasma.
Specimen Required
Supplies: BD UVT with mini tip flocked swab (T971)
Collection Container/Tube: Flocked swab
Submission Container/Tube: Sterile, screw-capped, tube containing viral transport media with flocked swab containing saliva. See Collection Instructions for acceptable media.
Specimen Volume: 1 Swab in viral transport media
Collection Instructions:
1. Collect a saliva specimen using a flocked swab per swab manufacturer instructions.
2. Place in a sterile, screw capped tube containing BD Universal Viral Transport Medium (UVT) (1 mL or 3 mL), Copan Universal Transport Medium (UTM) (1 mL or 3 mL), Remel M4-RT, Remel M4, or Remel M6.
Useful For
Aiding in the rapid diagnosis of cytomegalovirus (CMV) infections in neonates 21 days of age or younger using saliva specimens
Reporting Name
Congenital CMV, PCR, SalivaSpecimen Type
SwabSpecimen Minimum Volume
Saliva swab submitted in minimum volume of 0.3 mL of viral transport media.
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Swab | Frozen | 7 days |
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 saliva swab specimens (n=47) and contrived saliva samples (n=8) were tested, and the results compared to those of a routine, lab-developed (LDT) CMV PCR assay.(4) Results are summarized in the Table:
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Table. Saliva Accuracy
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a. There were three initial Simplexa internal control failures; all saliva swab samples were retested by Simplexa in singlet. Two samples returned valid results and one repeated as invalid.
Simplexa cCMV Direct assay accuracy results for saliva samples produced 100% positive agreement, 96% negative agreement, and 98% overall agreement.
Method Description
The Simplexa Congenital CMV Direct assay is a real-time polymerase chain reaction (PCR) system that enables the direct amplification and detection of CMV DNA from either saliva swab or urine specimens without nucleic acid extraction. The system consists of the Simplexa Congenital CMV Direct Reaction Mix, the LIAISON MDX (with LIAISON MDX Studio Software), the direct amplification disc, and associated accessories.
In the Simplexa Congenital CMV Direct assay, bifunctional fluorescent probe-primers are used together with corresponding reverse primers to amplify CMV DNA. A well-conserved region of the CMV UL83 gene is targeted to identify CMV DNA. An internal control is used to detect PCR failure or inhibition.(Package insert: Simplexa Congenital CMV Direct. Diasorin; REF MOL2255. Rev. 01, 011/2022)
Day(s) Performed
Monday through Sunday
Report Available
Same day/1 to 2 daysSpecimen Retention Time
7 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
CPT Code Information
87496
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| CCMVS | Congenital CMV, PCR, Saliva | 83065-3 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 620659 | Congenital CMV, PCR, Saliva | 83065-3 |