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Test 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 minitip flocked swab (T971)

Collection Container/Tube: Flocked swab

Submission Container/Tube: Sterile, screw-capped, tube containing viral transport media with flocked swab containing saliva

Specimen Volume: 1 Swab in viral transport media

Collection Instructions: Collect and send specimen per swab manufacturer instructions.


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, Saliva

Specimen Type

Swab

Specimen Minimum Volume

Saliva swab submitted in minimum volume of 0.3 mL of viral transport media.

Specimen Stability Information

Specimen Type Temperature Time Special Container
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:

Table. Saliva Accuracy

Simplexa Congenital CMV Direct results

CMV LDT PCR results

 

Positive

Negative

Positive

30(a)

0

Negative

0

24(a)

Invalid

0

1(a)

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.

Day(s) Performed

Monday through Sunday

Report Available

Same day/1 to 2 days

Specimen Retention Time

7 days

Performing 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